NCT07271706

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2026

Completed
Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

10 days

First QC Date

November 21, 2025

Last Update Submit

December 6, 2025

Conditions

Keywords

laughter yogadiabeticcomfortself-governance

Outcome Measures

Primary Outcomes (2)

  • Diabetes Self-Management Score (Diabetes Self-Management Questionnaire - DSMQ)

    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)

    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

Study Arms (2)

control group

NO INTERVENTION

Laughter yoga

EXPERIMENTAL
Behavioral: Laughter yoga

Interventions

Laughter yogaBEHAVIORAL

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.

Laughter yoga

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Type 2 diabetes
  • Age 18 years or older
  • Willingness to participate in the Laughter Yoga intervention
  • Ability to read and comprehend Turkish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Laughter Yoga Protocol The 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: 1. 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. 2. 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. 3. Diaphragmatic Breathing and Relaxat
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 9, 2025

Study Start

December 15, 2025

Primary Completion

December 25, 2025

Study Completion

January 25, 2026

Last Updated

December 9, 2025

Record last verified: 2025-11