Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT04728503
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-23', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-24', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale - Anxiety 1 (Change in Anxiety)', 'timeFrame': 'baseline, pre-intervention/procedure', 'description': 'Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety.'}, {'measure': 'Visual Analogue Scale - Anxiety 2 (Change in Anxiety)', 'timeFrame': 'immediately after the intervention', 'description': 'Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety.'}, {'measure': 'Visual Analogue Scale - Anxiety 3 (Change in Anxiety)', 'timeFrame': 'immediately after the procedure', 'description': 'Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety.'}, {'measure': 'Visual Analogue Scale - Pain 1', 'timeFrame': 'baseline, pre-intervention', 'description': 'Using an iPad, participant slides a bar on a scale to the right or left to indicate level of pain. All the way to the right indicates highest pain (100) all the way to the left indicates no pain (0). Higher number indicates worse outcome/more pain.'}, {'measure': 'Visual Analogue Scale - Pain 2', 'timeFrame': 'immediately after the procedure', 'description': 'Using an iPad, participant slides a bar on a scale to the right or left to indicate level of pain. All the way to the right indicates highest pain (100) all the way to the left indicates no pain (0). Higher number indicates worse outcome/more pain.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'baseline, pre-intervention/procedure', 'description': 'Depression symptom severity scale; 9 items with a total score ranging from 0-27, higher score means a greater number of depressive symptoms endorsed. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.'}, {'measure': 'Exam Satisfaction Survey', 'timeFrame': 'immediately after the procedure', 'description': 'Assess overall patient satisfaction with exam, and likelihood to attend future appointments'}, {'measure': 'Mindfulness Perceptions Survey', 'timeFrame': 'immediately after the procedure', 'description': 'Treatment group completes a survey regarding perceptions of mindfulness video'}, {'measure': 'Physician Experience Survey', 'timeFrame': 'immediately after the procedure', 'description': 'Physician who completes the pelvic exam will rate their experience completing the pelvic exam'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety State', 'Pain', 'Depression']}, 'descriptionModule': {'briefSummary': "This study endeavors to implement a brief video-based mindfulness intervention within a clinic setting for women undergoing pelvic examinations, in hopes of reducing state anxiety and pain intensity during pelvic exams and improving overall exam satisfaction and likelihood to return for follow-up exams. This will be a pilot study will take place the University of Texas Southwestern (UTSW) Lowe Foundation Center for Women's Preventative Health Care. There will be a treatment and a control arm, estimated 50 women per group.", 'detailedDescription': 'Participants will be randomly assigned to either a treatment group or a control group. Treatment group will receive a 5-minute mindful movement video-based intervention before their previously scheduled pelvic exam. Control group will not receive the mindful movement video-based intervention and will instead be given a handout about the benefits of mindfulness to read prior to the pelvic exam. Control group will be given access to the mindfulness intervention via an online link upon completion of participation in the study to ensure they are provided the opportunity to benefit from mindfulness practice.\n\nParticipants will be recruited from a group of female patients at the Lowe Foundation Center who have already been scheduled for an upcoming pelvic exam. Therefore the pelvic exam procedure itself is standard of care, the experimental piece is the mindfulness intervention before the pelvic exam - either the video, or the written educational materials depending on whether participants are randomly assigned to the treatment or control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female\n2. Age of 18+ years\n3. Scheduled physical evaluation including pelvic exam at UT Southwestern's Lowe Foundation Center for Women's Preventative Health Care.\n\nExclusion Criteria:\n\n1. Participants who are unable to read, speak, write or understand verbally spoken English\n2. Participants who are blind or otherwise visually impaired will be excluded due to nature of video intervention.\n3. Participants who are pregnant will be excluded from the study.\n4. Individuals presenting to the clinic for an acute pain reason will be excluded from the study."}, 'identificationModule': {'nctId': 'NCT04728503', 'briefTitle': 'Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams', 'orgStudyIdInfo': {'id': 'STU-2019-1782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-Minute Mindful Movement Video', 'description': '5 minute mindful movement video watched in the exam room on an iPad', 'interventionNames': ['Behavioral: 5-Minute Mindful Movement Video']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Written Educative Materials', 'description': '1 page printed written educative material about mindfulness benefits read for 5 minutes in the exam room', 'interventionNames': ['Behavioral: Written Educative Materials']}], 'interventions': [{'name': '5-Minute Mindful Movement Video', 'type': 'BEHAVIORAL', 'description': '5 minute video includes a brief verbal introduction to mindfulness and then guides participants through a mindful movement exercise to facilitate grounding in the present moment and activation of the parasympathetic nervous system.', 'armGroupLabels': ['5-Minute Mindful Movement Video']}, {'name': 'Written Educative Materials', 'type': 'BEHAVIORAL', 'description': '1 page written educative material about the benefits of mindfulness to serve as a control.', 'armGroupLabels': ['Written Educative Materials']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Tracy Greer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not have a formal data sharing plan; however, if investigators are interested in using these data, they may contact us to determine if that may be possible.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Psychiatry', 'investigatorFullName': 'Tracy Greer', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}