The Effect of Laughter Yoga in Type 2 D… | Clinical Trial

Key information

Conditions

Diabetic Comfort Laughter Yoga

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laughter Yoga

Behavioral

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.

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

The Effect of Laughter Yoga on Self-management and Comfort in Type 2 Diabetes Patients

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Dec 9, 2025
Registry last updated: Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting