- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271706
The Effect of Laughter Yoga in Type 2 Diabetes Patients
The Effect of Laughter Yoga on Self-management and Comfort in Type 2 Diabetes Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Katharine 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.
This study aims to evaluate the effects of Laughter Yoga on self-management behaviors and comfort levels among individuals with Type 2 diabetes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Diagnosis of Type 2 diabetes
- Age 18 years or older
- Willingness to participate in the Laughter Yoga intervention
- Ability to read and comprehend Turkish
Exclusion Criteria
- Diagnosis of Type 1 diabetes
- Participation in individual psychotherapy or group-based psychological intervention programs
- Experience of a recent loss within the past month (e.g., death, divorce)
- Presence of any psychiatric diagnosis
- Use of psychiatric medication
- Severe visual or hearing impairment preventing active participation in the intervention
- Pregnancy or breastfeeding
- Limitations in reading or comprehending Turkish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Experimental: Laughter yoga
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Self-Management Score (Diabetes Self-Management Questionnaire - DSMQ)
Time Frame: Baseline (Day 0) and Week 4
|
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: Glucose Management Dietary Control Physical Activity Health-Care Use Items 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. |
Baseline (Day 0) and Week 4
|
|
Comfort Level Score (General Comfort Questionnaire - Short Form)
Time Frame: Baseline (Day 0) and Week 4
|
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: Relief Ease Transcendence Items 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. |
Baseline (Day 0) and Week 4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Yobu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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