Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 9:10 AM
Study NCT ID:
NCT07271706
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Laughter Yoga in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D027641', 'term': 'Laughter Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Laughter Yoga Protocol\n\nThe Laughter Yoga program administered to participants in the intervention group will be structured in accordance with protocols used in similar studies in the literature. The program will be conducted twice a week for four weeks. Each session will last approximately 40 minutes and will include the following four components:\n\n1. Warm-up and Breathing Exercises (5-7 minutes) Participants will engage in gentle warm-up movements and guided breathing exercises to promote relaxation, increase body awareness, and prepare for laughter activities.\n2. Laughter Exercises (15-20 minutes) Participants will perform voluntary laughter through instructor-guided techniques. These exercises are designed to activate the diaphragm, enhance oxygenation, stimulate positive emotional states, and increase parasympathetic activity. Techniques may include greeting laughter, clapping rhythms, playful interactions, and simulated laughter sequences.\n3. Diaphragmatic Breathing and Relaxat'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes Self-Management Score (Diabetes Self-Management Questionnaire - DSMQ)', 'timeFrame': 'Baseline (Day 0) and Week 4', 'description': 'The Diabetes Self-Management Questionnaire (DSMQ), originally developed by Schmitt et al. (2013), will be used to evaluate diabetes self-management behaviors. The DSMQ consists of 16 items and four subscales:\n\nGlucose Management\n\nDietary Control\n\nPhysical Activity\n\nHealth-Care Use\n\nItems are rated on a 4-point Likert scale (0-3). Seven items are scored positively, and nine items are reverse-scored. Total scores are calculated by dividing the raw score by the maximum possible score and multiplying by 10. The resulting values range from 0 to 10, with higher scores indicating better diabetes self-management.'}, {'measure': 'Comfort Level Score (General Comfort Questionnaire - Short Form)', 'timeFrame': 'Baseline (Day 0) and Week 4', 'description': 'The General Comfort Questionnaire - Short Form, developed by Kolcaba (2006), will be used to assess comfort levels across physical, psychospiritual, environmental, and social domains. The scale consists of 28 items and three subscales:\n\nRelief\n\nEase\n\nTranscendence\n\nItems are rated on a 6-point Likert scale (1-6). Negative items are reverse-scored. The total comfort score ranges from 1 to 6, with higher scores indicating greater comfort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laughter yoga', 'diabetic', 'comfort', 'self-governance'], 'conditions': ['Diabetic', 'Laughter Yoga', 'Comfort']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of laughter yoga on self-management skills and comfort levels in patients with Type 2 diabetes.', 'detailedDescription': "Diabetes is a major global health problem affecting more than 537 million adults worldwide, a number expected to rise substantially in the coming decades. Type 2 diabetes, the most prevalent form, requires consistent self-management to maintain glycemic control and prevent complications. However, individuals living with chronic illness often experience ongoing physiological fatigue and emotional stress, which can reduce self-efficacy and hinder engagement in self-management behaviors. Comfort, identified as an important psychological resource, plays a supportive role in sustaining these behaviors.\n\nKatharine Kolcaba's Comfort Theory proposes that health behaviors can be positively influenced by enhancing individuals' physical, psychospiritual, sociocultural, and environmental comfort. Laughter Yoga-a mind-body intervention combining intentional laughter with breathing and relaxation techniques-has been shown to reduce stress, improve mood, and increase parasympathetic activity. Previous studies involving individuals with Type 2 diabetes have reported reductions in HbA1c, decreased stress levels, and improved quality of life following Laughter Yoga interventions. However, limited research has simultaneously examined its effects on both self-management behaviors and comfort levels.\n\nThis study aims to evaluate the effects of Laughter Yoga on self-management behaviors and comfort levels among individuals with Type 2 diabetes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Diagnosis of Type 2 diabetes\n* Age 18 years or older\n* Willingness to participate in the Laughter Yoga intervention\n* Ability to read and comprehend Turkish\n\nExclusion Criteria\n\n* Diagnosis of Type 1 diabetes\n* Participation in individual psychotherapy or group-based psychological intervention programs\n* Experience of a recent loss within the past month (e.g., death, divorce)\n* Presence of any psychiatric diagnosis\n* Use of psychiatric medication\n* Severe visual or hearing impairment preventing active participation in the intervention\n* Pregnancy or breastfeeding\n* Limitations in reading or comprehending Turkish'}, 'identificationModule': {'nctId': 'NCT07271706', 'briefTitle': 'The Effect of Laughter Yoga in Type 2 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bozok University'}, 'officialTitle': 'The Effect of Laughter Yoga on Self-management and Comfort in Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': 'Yobu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group'}, {'type': 'EXPERIMENTAL', 'label': 'Laughter yoga', 'interventionNames': ['Behavioral: Laughter yoga']}], 'interventions': [{'name': 'Laughter yoga', 'type': 'BEHAVIORAL', 'description': 'Arm Description: A structured laughter yoga program delivered twice weekly for four weeks. Each 40-minute session includes warm-up and breathing exercises (5-7 min), guided laughter exercises (15-20 min), diaphragmatic breathing and relaxation (5-7 min), and mindfulness-based closing practices (3-5 min). Conducted by a certified facilitator.', 'armGroupLabels': ['Laughter yoga']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bozok University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer Doctor', 'investigatorFullName': 'Betül Bal', 'investigatorAffiliation': 'Bozok University'}}}}