Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00735618
Status:
COMPLETED
Last Update Posted:
2011-12-19
First Post:
2008-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Relaxation and Heart Rate Variability
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jaallo@mdanderson.org', 'title': 'Ying Guo, MD, MS/Associate Professor', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Guided Relaxation', 'description': 'Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Differences Between Pre/Post ESAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Guided Relaxation', 'description': 'Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program and summed ESAS scores'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.1', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)', 'description': 'Total symptom burden as measured by Edmonton Symptom Assessment Scale (ESAS) in which there are eight visual analog scales (VAS) of 0 to 10, with 10 being most severe. The differences from ESAS baseline (before) to post (after) a 15 minute, one-time, guided relaxation program for each participant assessed, with the average difference in ESAS scores for all participants reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all study participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Guided Relaxation', 'description': 'Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment Period: 7/09/2008 through 7/10/2008. All participants recruited at University of Texas MD Anderson Cancer Center.', 'preAssignmentDetails': 'One of twenty enrolled participants did not meet eligibility criteria and was excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Guided Relaxation', 'description': 'Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-15', 'studyFirstSubmitDate': '2008-08-12', 'resultsFirstSubmitDate': '2009-03-03', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-15', 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences Between Pre/Post ESAS Score', 'timeFrame': 'Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)', 'description': 'Total symptom burden as measured by Edmonton Symptom Assessment Scale (ESAS) in which there are eight visual analog scales (VAS) of 0 to 10, with 10 being most severe. The differences from ESAS baseline (before) to post (after) a 15 minute, one-time, guided relaxation program for each participant assessed, with the average difference in ESAS scores for all participants reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Cancer', 'Cancer Patients', 'Relaxation Therapy', 'Relaxation and Heart Rate Variability', 'Guided Relaxation', 'HRV', 'Stress, Anxiety, and Panic Disorder'], 'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'U.T. M.D. Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Primary:\n\n* To characterize the physiologic changes of the autonomic nervous system, demonstrated by heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program for cancer patients.\n\nSecondary:\n\n* To assess whether change of HRV correlates with subjective feeling for anxiety, based on visual analog scale scores.', 'detailedDescription': 'Rhythm changes in your heart rate are part of the "autonomic" nervous system. This is the part of your nervous system that controls the body functions that you do not have to think about. Researchers want to find out if a "guided relaxation" session will make your heart rate more variable, with more rhythm changes.\n\nIf you are found to be eligible to take part in this study, you will first answer a brief questionnaire that will measure several symptoms, such as pain and anxiety (worry). This questionnaire will take less than 5 minutes. You will also be asked questions about your alcohol and smoking history, and if you have ever used relaxation or meditation techniques in the past. This will also take less than 5 minutes.\n\nYou will then be asked to lay on your back, on a hospital bed or exam table. Electrodes will be placed along your chest, the same way they are placed for an electrocardiogram (ECG--a test to measure the electrical activity of the heart). You will be asked to rest for 15 minutes, and then your heart rhythm will be recorded for 5 minutes. After this first recording, you will begin the relaxation program by listening to an audio recording for about 15 minutes, using headphones. After the relaxation program has ended, your heart rhythm will be recorded for another 5-minute period while you are resting.\n\nYou will then be asked to complete the same questionnaire as before.\n\nThe entire procedure will take about 45-60 minutes. After this second questionnaire, your participation on this study will be over.\n\nThis is an investigational study. Up to 20 people will take part in this study. All will be enrolled at M. D. Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written informed consent\n2. Normal cognition (per treating physician's assessment)\n\nExclusion Criteria:\n\n1. Dementia\n2. Psychosis\n3. Delirium\n4. Not fluent in English\n5. Cardiac dysrhythmia\n6. Inability to lay supine\n7. Pacemaker"}, 'identificationModule': {'nctId': 'NCT00735618', 'briefTitle': 'Relaxation and Heart Rate Variability', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Pilot Study on the Effects of a Brief Relaxation Program on Heart Rate Variability in Cancer Patients', 'orgStudyIdInfo': {'id': '2008-0028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guided Relaxation', 'description': 'Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program', 'interventionNames': ['Other: Guided Relaxation']}], 'interventions': [{'name': 'Guided Relaxation', 'type': 'OTHER', 'otherNames': ['Relaxation Therapy', 'Guided Relaxation Program'], 'description': 'Following 5 minute questionnaire, 15 minute rest and 5 minute heart rhythm recording, 15 minute relaxation program (listening via headphone to audio recording) to be completed by second heart rhythm recording and same questionnaire. Entire procedure 45-60 minutes.', 'armGroupLabels': ['Guided Relaxation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ying Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U.T. M.D. Anderson Cancer Center Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}