Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT02690194
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2016-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Greggory.Kobelski@childrens.harvard.edu', 'phone': '7812161093', 'title': 'Greggory Kobelski', 'organization': "Boston Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'title': 'BP-Systolic', 'categories': [{'measurements': [{'value': '121.9', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '121.9', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '127.3', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': 'BP-Diastolic', 'categories': [{'measurements': [{'value': '77.2', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '78.9', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '82.2', 'spread': '11.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-therapy/pre-procedure', 'description': 'Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pre-therapy/Pre-procedure Stress Level Measured by Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '66.4', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '69.5', 'spread': '11.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-therapy/pre-procedure', 'description': 'Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '14.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-therapy/pre-procedure', 'description': 'Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pre-therapy/Pre-procedure Anxiety Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'title': 'S-Anxiety Score', 'categories': [{'measurements': [{'value': '33.1', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '34.4', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '31.4', 'spread': '7.1', 'groupId': 'OG002'}]}]}, {'title': 'T-Anxiety Score', 'categories': [{'measurements': [{'value': '35.6', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '32.4', 'spread': '9.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-therapy/pre-procedure', 'description': 'Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'groupId': 'OG000', 'lowerLimit': '-8.1', 'upperLimit': '7.8'}, {'value': '3.48', 'groupId': 'OG001', 'lowerLimit': '-5.1', 'upperLimit': '12.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-therapy/pre-procedure', 'description': 'Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute. Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected for the control group in this Outcome Measure'}, {'type': 'SECONDARY', 'title': 'Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'groupId': 'OG000', 'lowerLimit': '-0.78', 'upperLimit': '0.51'}, {'value': '-0.70', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-therapy/pre-procedure', 'description': 'Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected for the control group in this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Post-therapy/Pre-procedure Change in Anxiety Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}], 'classes': [{'title': 'S-Anxiety Score', 'categories': [{'measurements': [{'value': '-2.82', 'groupId': 'OG000', 'lowerLimit': '-8.4', 'upperLimit': '2.7'}, {'value': '-12.3', 'groupId': 'OG001', 'lowerLimit': '-18.3', 'upperLimit': '-6.3'}]}]}, {'title': 'T-Anxiety Score', 'categories': [{'measurements': [{'value': '-8.44', 'groupId': 'OG000', 'lowerLimit': '-15.2', 'upperLimit': '-1.7'}, {'value': '-3.92', 'groupId': 'OG001', 'lowerLimit': '-11.2', 'upperLimit': '3.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-therapy/pre-procedure', 'description': 'Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected for the control group in this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}], 'classes': [{'title': 'BP-Systolic', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '11.3'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-9.1', 'upperLimit': '6.9'}]}]}, {'title': 'BP-Diastolic', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '12.4'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-7.1', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-therapy/Pre-procedure', 'description': 'Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected for the control group in this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately post-procedure', 'description': 'Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10. A score of 1 indicates "no hurt" (a better outcome) while a score of 10 indicates "hurts worst" (worst outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Drink in Last Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}, {'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Indication of if the patient has had a drink in the last hour', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Eat in Last Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Indication of if the patient has eaten in the last hour', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exercise in Last Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}, {'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Indication of if the patient has exercised in the last hour', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Injection Experiences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'Data Not Collected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Indication of prior injection experiences', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'OG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Average number of injections for patients that indicated that they previously have had injections', 'unitOfMeasure': 'Number of injections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that have had injections in the past'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'FG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'FG002', 'title': 'Control Group', 'description': '1. Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Control group data was not analyzed for all measures'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nPlacebo Group: The placebo group will wear headphones and listen to nature sounds.'}, {'id': 'BG001', 'title': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure\n\nBuddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.'}, {'id': 'BG002', 'title': 'Control Group', 'description': '1. Pre-Procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50.9', 'spread': '18.0', 'groupId': 'BG000'}, {'value': '53.9', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '55.5', 'spread': '17.1', 'groupId': 'BG002'}, {'value': '52.4', 'spread': '2.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'For the control group there were no post-therapy/pre-procedure data collected because there was no therapy for the control group.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2016-02-09', 'resultsFirstSubmitDate': '2018-09-04', 'studyFirstSubmitQcDate': '2016-02-19', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-20', 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure', 'timeFrame': 'Pre-therapy/pre-procedure', 'description': 'Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg'}, {'measure': 'Pre-therapy/Pre-procedure Stress Level Measured by Pulse', 'timeFrame': 'Pre-therapy/pre-procedure', 'description': 'Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.'}, {'measure': 'Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate', 'timeFrame': 'Pre-therapy/pre-procedure', 'description': 'Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.'}, {'measure': 'Pre-therapy/Pre-procedure Anxiety Level', 'timeFrame': 'Pre-therapy/pre-procedure', 'description': 'Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse', 'timeFrame': 'Post-therapy/pre-procedure', 'description': 'Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute. Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure.'}, {'measure': 'Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate', 'timeFrame': 'Post-therapy/pre-procedure', 'description': 'Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.'}, {'measure': 'Post-therapy/Pre-procedure Change in Anxiety Level', 'timeFrame': 'Post-therapy/pre-procedure', 'description': 'Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.'}, {'measure': 'Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure', 'timeFrame': 'Post-therapy/Pre-procedure', 'description': 'Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.'}, {'measure': 'Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale', 'timeFrame': 'Immediately post-procedure', 'description': 'Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10. A score of 1 indicates "no hurt" (a better outcome) while a score of 10 indicates "hurts worst" (worst outcome).'}, {'measure': 'Drink in Last Hour', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Indication of if the patient has had a drink in the last hour'}, {'measure': 'Eat in Last Hour', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Indication of if the patient has eaten in the last hour'}, {'measure': 'Exercise in Last Hour', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Indication of if the patient has exercised in the last hour'}, {'measure': 'Injection Experiences', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Indication of prior injection experiences'}, {'measure': 'Number of Injections', 'timeFrame': 'Pre-therapy/Pre-procedure', 'description': 'Average number of injections for patients that indicated that they previously have had injections'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Buddhify', 'Stress', 'Anxiety', 'Relaxation Technique'], 'conditions': ['Pain', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '25254059', 'type': 'BACKGROUND', 'citation': 'Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2.'}, {'pmid': '22092955', 'type': 'BACKGROUND', 'citation': 'Ko YL, Lin PC. The effect of using a relaxation tape on pulse, respiration, blood pressure and anxiety levels of surgical patients. J Clin Nurs. 2012 Mar;21(5-6):689-97. doi: 10.1111/j.1365-2702.2011.03818.x. Epub 2011 Nov 17.'}, {'pmid': '15110929', 'type': 'BACKGROUND', 'citation': 'Ebrecht M, Hextall J, Kirtley LG, Taylor A, Dyson M, Weinman J. Perceived stress and cortisol levels predict speed of wound healing in healthy male adults. Psychoneuroendocrinology. 2004 Jul;29(6):798-809. doi: 10.1016/S0306-4530(03)00144-6.'}, {'pmid': '15471050', 'type': 'BACKGROUND', 'citation': "Worley CA. 'Why won't this wound heal?' Factors affecting wound repair. Dermatol Nurs. 2004 Aug;16(4):360-1. No abstract available."}, {'pmid': '24957817', 'type': 'BACKGROUND', 'citation': 'Lim YC, Yobas P, Chen HC. Efficacy of relaxation intervention on pain, self-efficacy, and stress-related variables in patients following total knee replacement surgery. Pain Manag Nurs. 2014 Dec;15(4):888-96. doi: 10.1016/j.pmn.2014.02.001. Epub 2014 Jun 21.'}, {'pmid': '7475659', 'type': 'BACKGROUND', 'citation': 'Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress. Lancet. 1995 Nov 4;346(8984):1194-6. doi: 10.1016/s0140-6736(95)92899-5.'}, {'pmid': '25271180', 'type': 'BACKGROUND', 'citation': 'Heilbrunn BR, Wittern RE, Lee JB, Pham PK, Hamilton AH, Nager AL. Reducing anxiety in the pediatric emergency department: a comparative trial. J Emerg Med. 2014 Dec;47(6):623-31. doi: 10.1016/j.jemermed.2014.06.052. Epub 2014 Sep 27.'}, {'pmid': '33904781', 'type': 'DERIVED', 'citation': 'Sugimoto D, Slick NR, Mendel DL, Stein CJ, Pluhar E, Fraser JL, Meehan WP 3rd, Corrado GD. Meditation Monologue can Reduce Clinical Injection-Related Anxiety: Randomized Controlled Trial. J Evid Based Integr Med. 2021 Jan-Dec;26:2515690X211006031. doi: 10.1177/2515690X211006031.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing the stress and anxiety levels of patients. The secondary aim is to investigate the effect of prior stress and anxiety levels on the perceived pain level of undergoing a medical procedure, reported post-procedure.', 'detailedDescription': "Undergoing medical procedures is reported to cause stress and anxiety among many individuals.This can trigger the sympathetic nervous response, including decreased skin temperature, increased pulse, and increased blood pressure. While evolutionary advantageous, this response has deleterious effects on the healing process. Heightened stress levels can also trigger an increased release of cortisol, a naturally produced steroid hormone known to hinder the immune response. In response to high levels of stress, a patient's tolerance for pain decreases and the perceived pain level increases.\n\nRelaxation techniques can assist in reducing the stress and anxiety levels of a patient, which allows for lower perceived pain and more rapid healing. Many relaxation techniques exist, including acupuncture, child life intervention, breathing therapy and guided imagery. Buddhify, a mobile application, incorporates breathing therapy and audio-guided imagery into brief relaxation sessions, with the goal of reducing the stress and anxiety levels of the user. This application presents a convenient option for patients to use prior to undergoing a procedure. If proven to be effective, this application could be more widely used to help reduce the stress level, anxiety level and subsequent perceived pain level of patients, ultimately improving their healing reaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital.\n\nExclusion Criteria:"}, 'identificationModule': {'nctId': 'NCT02690194', 'briefTitle': 'A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures', 'orgStudyIdInfo': {'id': 'IRB-P00016464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': '1. Pre-Placebo therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PLACEBO THERAPY SESSION\n3. Post-Placebo therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure', 'interventionNames': ['Device: Placebo Group']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental (Buddhify) Group', 'description': '1. Pre-Buddhify therapy\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. BUDDHIFY THERAPY SESSION\n3. Post-Buddhify therapy/Pre-procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n4. PROCEDURE\n5. Post-procedure -Rate pain level of procedure', 'interventionNames': ['Device: Buddhify Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '1. Pre-Procedure\n\n * Blood pressure, pulse, and respiration rate\n * State-Trait Anxiety Inventory\n2. PROCEDURE\n3. Post-procedure -Rate pain level of procedure'}], 'interventions': [{'name': 'Placebo Group', 'type': 'DEVICE', 'description': 'The placebo group will wear headphones and listen to nature sounds.', 'armGroupLabels': ['Placebo Group']}, {'name': 'Buddhify Therapy', 'type': 'DEVICE', 'description': 'The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.', 'armGroupLabels': ['Experimental (Buddhify) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Childrens Hospital - Sports Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gianmichel Corrado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gianmichel D. Corrado, MD', 'investigatorFullName': 'Gianmichel Corrado', 'investigatorAffiliation': "Boston Children's Hospital"}}}}