The Effect of Laughter Yoga in Type 2 Diabetes Patients

December 6, 2025 updated by: Betül Bal, Bozok University

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

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.

Study Overview

Status

Not yet recruiting

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

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

December 25, 2025

Study Completion (Estimated)

January 25, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 6, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Yobu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Comfort

Clinical Trials on Laughter yoga

Subscribe