Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT05572294
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2022-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the intervention as measured by the proportion of sickle cell patients admitted over a consecutive 12 week time period who agree to participate in the study', 'timeFrame': '12 weeks'}, {'measure': 'Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization', 'timeFrame': '12 weeks'}, {'measure': 'Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpful', 'timeFrame': 'at the time of hospital discharge, up to 6 months post-intervention', 'description': 'This data will be collected via a post-intervention survey and interview. The survey will contain simple questions with yes/no answer options. The interview will be conducted by a study member, either in-person or by telephone.'}, {'measure': 'Acceptability of the intervention as measured by the proportion of participants who are interested in pursuing mindfulness therapies in the future', 'timeFrame': 'at the time of hospital discharge, up to 6 months post-intervention', 'description': 'This data will be collected via a post-intervention survey and interview. The survey will contain simple questions with yes/no answer options. The interview will be conducted by a study member, either in-person or by telephone.'}, {'measure': 'Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization', 'timeFrame': 'at the time of hospital discharge, up to 6 months post-intervention'}, {'measure': 'Participant engagement as measured by the percentage of videos completed. A video is considered completed if the participant watches more than 85% of the video.', 'timeFrame': 'at the time of hospital discharge, up to 6 months post-intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle Cell Disease', 'Yoga Therapy', 'Mindfulness'], 'conditions': ['Sickle Cell Crisis', 'Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'Patients with sickle cell disease suffer from acute and chronic pain that diminishes their quality of life. The purpose of this study is to assess the feasibility and acceptability of mindfulness meditation, breathing exercises, and gentle yoga therapy as supportive measures for the management of acute vaso-occlusive pain crises in the inpatient setting.', 'detailedDescription': "This is a prospective single arm study of mindfulness interventions for sickle cell patients admitted with an acute vaso-occlusive pain crisis. Patients will be accrued over a consecutive 12 week period. All genotypes of sickle cell disease will be eligible for enrollment.\n\nAfter providing informed consent, the patients will have access to 4 videos on their hospital room television. The videos contain guided mindfulness meditation, breathing exercises (including the use of an incentive spirometer), and gentle yoga therapy that can be performed in the supine position from a hospital bed. Videos vary in length from 5-12 minutes. Participants will have the ability to watch the videos as many times as they choose. They may also turn off the video at any time.\n\nThe primary outcome is feasibility and acceptability of the intervention. We will record objective data on how many videos are watched by each participant, as well as the percentage of each video completed. We will obtain information about the participants' perception of the intervention through a post-intervention survey and interview."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with sickle cell disease, any genotype\n* Adult patients at least 18 years of age\n* English speaking\n* Admitted to Clements University Hospital with an acute vaso-occlusive pain crisis\n\nExclusion criteria:\n\n* Unable to follow simple instructions\n* Admitted to the intensive care unit'}, 'identificationModule': {'nctId': 'NCT05572294', 'briefTitle': 'Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'STU-2021-0729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness and Yoga Therapy', 'description': 'Participants will have access to video-guided mindfulness interventions.', 'interventionNames': ['Behavioral: Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy']}], 'interventions': [{'name': 'Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy', 'type': 'BEHAVIORAL', 'description': 'Sickle cell patients admitted with a vaso-occlusive pain crisis over a consecutive 12-week period will be offered participation in the study. After providing informed consent, participants will have access to 4 videos containing guided mindfulness meditation, breathing exercises, and gentle yoga therapy. The videos are 5-12 minutes long and taught by a physical therapist who is also certified in yoga therapy. Participants may turn off the video at any time. Participants will have access to the videos for the duration of their hospitalization, and they may watch the videos as many times as they desire.', 'armGroupLabels': ['Mindfulness and Yoga Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Siayareh Rambally, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Siayareh Rambally', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}