Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 2:26 AM
Study NCT ID:
NCT07171268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga Asana Chandra Harmoni on Psychological Well-being and Learning Readiness Among Medical Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "To minimize bias, this study will implement masking procedures. Specifically, investigators involved in direct participant interaction will not be masked because of the nature of intervention (yoga classes require a known instructor), The outcome assessors responsible for administering and scoring the questionnaires (DASS-21, PSQI, SDLR, and Self-Efficacy) will be masked to the participant's group assignment."}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The Yoga Asana Chandra Harmoni intervention is a structured yoga program based on a specific sequence of asanas, pranayama (breathing exercises), and meditation techniques. The core asana sequence includes both static and dynamic movements designed to promote physical flexibility, strength, and balance. Pranayama techniques focus on regulating the breath to calm the nervous system and reduce stress. Meditation practices aim to cultivate mindfulness and improve emotional regulation. The intervention will be delivered in two phases: an initial face-to-face instruction session, followed by independent practice supported by a video and WhatsApp support. Participants in the intervention group will also be prescribed with online audio guided practices 5 times/week for 20-30 minutes. The audio practice will include breathing exercises (weeks 1-2) and body scans (weeks 3-4).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological well-being (measured by the Depression Anxiety Stress Scales - DASS-21)', 'timeFrame': 'Baseline (Prior to the intervention); Post-test (Immediately following the 4-week intervention period); Follow-up (Two weeks after the post-test assessment).', 'description': 'The DASS-21 is a self-report instrument that assesses the severity of symptoms of depression, anxiety, and stress experienced by individuals.'}], 'secondaryOutcomes': [{'measure': 'Sleep Quality (Measured by the Pittsburgh Sleep Quality Index - PSQI)', 'timeFrame': 'Baseline (Prior to the intervention); Post-test (Immediately following the 4-week intervention period); Follow-up (Two weeks after the post-test assessment).', 'description': 'The PSQI is a self-report questionnaire designed to assess sleep quality and disturbances over a 1-month time interval.'}, {'measure': 'SDLR (measured by the Indonesian version of the Self-Directed Learning Readiness Scale - SDLR)', 'timeFrame': 'Baseline (Prior to the intervention); Post-test (Immediately following the 4-week intervention period); Follow-up (Two weeks after the post-test assessment).', 'description': "SDLR scale measures an individual's preparedness to engage in self-directed learning activities."}, {'measure': 'Self-Efficacy (Measured by the Indonesian version of the Student Self-Efficacy Scale)', 'timeFrame': 'Baseline (Prior to the intervention); Post-test (Immediately following the 4-week intervention period); Follow-up (Two weeks after the post-test assessment).', 'description': "Self-Efficacy scale measures students' belief in their ability to succeed in specific situations or accomplish a task"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Yoga', 'Yoga Exercises', 'Well Being', 'Self Efficacy', 'Medical Student', 'Health and Wellness']}, 'referencesModule': {'references': [{'pmid': '38861675', 'type': 'BACKGROUND', 'citation': 'Maity S, Abbaspour R, Bandelow S, Pahwa S, Alahdadi T, Shah S, Chhetri P, Jha AK, Nauhria S, Nath R, Nayak N, Nauhria S. The psychosomatic impact of Yoga in medical education: a systematic review and meta-analysis. Med Educ Online. 2024 Dec 31;29(1):2364486. doi: 10.1080/10872981.2024.2364486. Epub 2024 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to learn if the Yoga Asana Chandra Harmoni intervention can improve psychological well-being and learning readiness in medical students. The main questions it aims to answer are:\n\nDoes Yoga Asana Chandra Harmoni improve psychological well-being (specifically, reduce stress, anxiety, and depression) in medical students? Does Yoga Asana Chandra Harmoni enhance self-directed learning readiness in medical students? Researchers will compare a group receiving the Yoga Asana Chandra Harmoni intervention to a control group to see if the intervention leads to significant improvements in psychological well-being and self-directed learning readiness.\n\nParticipants will:\n\nComplete baseline questionnaires assessing psychological well-being, sleep quality, self-directed learning readiness, and self-efficacy.\n\nParticipate in 3 weekly Yoga Asana Chandra Harmoni sessions for 4 weeks (intervention group).\n\nContinue with their usual activities (control group). Complete follow-up questionnaires at post-test (end of week 4) and at a 2-week follow-up to assess changes in the outcome measures.\n\nEngage in additional online audio guided practices 5 times/week for 20-30 minutes, including breathing exercises (weeks 1-2) and body scans (weeks 3-4) (intervention group).', 'detailedDescription': 'Background \\& Rationale\n\nMedical students face significant academic pressures, leading to elevated levels of stress, anxiety, and depression. These psychological challenges can negatively impact their academic performance, sleep quality, and overall well-being. Furthermore, the demands of medical education necessitate effective self-directed learning skills. Yoga interventions have demonstrated potential for improving mental health and cognitive function in various populations. This study aims to rigorously evaluate the effectiveness of a specific yoga intervention, Yoga Asana Chandra Harmoni, in addressing these challenges within a medical student population.\n\nIntervention Details:\n\nThe Yoga Asana Chandra Harmoni intervention is a structured yoga program based on a specific sequence of asanas, pranayama (breathing exercises), and meditation techniques. The core asana sequence includes both static and dynamic movements designed to promote physical flexibility, strength, and balance. Pranayama techniques focus on regulating the breath to calm the nervous system and reduce stress. Meditation practices aim to cultivate mindfulness and improve emotional regulation. The intervention will be delivered in two phases: an initial face-to-face instruction session, followed by independent practice supported by a video and WhatsApp support. Participants in the intervention group will also be prescribed with online audio guided practices 5 times/week for 20-30 minutes. The audio practice will include breathing exercises (weeks 1-2) and body scans (weeks 3-4).\n\nStudy Design and Procedures:\n\nThis study will utilize a randomized controlled trial (RCT) design. Eligible participants will be randomly assigned to either the Yoga Asana Chandra Harmoni intervention group or a control group receiving no intervention. Randomization will be performed using computer-generated random numbers. To ensure minimal contamination, participants will be encouraged not to discuss the intervention with those in the control group.\n\nAdherence to the intervention will be monitored through self-reported practice logs. Participants will be asked to record the frequency and duration of their yoga practice. In the event of significant non-adherence, strategies will be employed to encourage participation, such as reminder messages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3rd-year medical student\n* Willing to attend yoga sessions and practice at home.\n* Willing to provide consent and complete assessments.\n\nExclusion Criteria:\n\n* Regular yoga practice (≥ 6 months).\n* Physical contraindications to yoga.\n* Active treatment for severe mental health disorder.\n* Concurrent participation in another intervention study.'}, 'identificationModule': {'nctId': 'NCT07171268', 'briefTitle': 'Yoga Asana Chandra Harmoni on Psychological Well-being and Learning Readiness Among Medical Students', 'organization': {'class': 'OTHER', 'fullName': 'Gadjah Mada University'}, 'officialTitle': 'A Randomized Controlled Trial of Yoga Asana Chandra Harmoni on Psychological Well-being and Learning Readiness Among Medical Students', 'orgStudyIdInfo': {'id': '025UN481604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants randomized to the control group will continue with their usual daily activities and academic routines. They will not receive the Yoga Asana Chandra Harmoni intervention during the study period.', 'interventionNames': ['Behavioral: Yoga Asana Chandra Harmoni']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-List Control Group', 'description': 'Participants randomized to the wait-list control group will continue with their usual daily activities and academic routines. They will not receive the Yoga Asana Chandra Harmoni intervention during the study period.'}], 'interventions': [{'name': 'Yoga Asana Chandra Harmoni', 'type': 'BEHAVIORAL', 'description': 'Description: Participants randomized to the intervention group will receive the Yoga Asana Chandra Harmoni program. This program is designed to improve psychological well-being, sleep quality, and self-directed learning readiness.\n\nComponents:\n\nInitial Face-to-Face Session: Participants will attend one in-person session led by a qualified yoga instructor. This session will introduce the principles of Yoga Asana Chandra Harmoni and provide instruction on the core asana sequence, breathing techniques (pranayama), and meditation.\n\nWeekly Yoga Sessions: Participants will engage in three 45-minute yoga sessions per week for four weeks, practicing the Yoga Asana Chandra Harmoni sequence.\n\nVideo Support: Participants will be provided with a video demonstrating the Yoga Asana Chandra Harmoni sequence to support their home practice. The video will be shared individually via Whatsapp.\n\nHome Practice: Participants are expected to practice the Yoga Asana Chandra Harmoni sequence independently at home,', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81116', 'city': 'Singaraja', 'state': 'Bali', 'country': 'Indonesia', 'contacts': [{'name': 'Made Satya Nugraha Gautama, RN, M.Sc.', 'role': 'CONTACT', 'email': 'satyanugraha.g@gmail.com', 'phone': '+6282247469181'}], 'facility': 'Universitas Pendidikan Ganesha', 'geoPoint': {'lat': -8.112, 'lon': 115.08818}}], 'centralContacts': [{'name': 'Made Satya Nugraha Gautama RN, M.Sc.', 'role': 'CONTACT', 'email': 'mgautama@undiksha.ac.id', 'phone': '+6282247469181'}], 'overallOfficials': [{'name': 'Made Kurnia Widiastuti Giri, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitas Pendidikan Ganesha'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gadjah Mada University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Made Satya Nugraha Gautama', 'investigatorAffiliation': 'Gadjah Mada University'}}}}