DiabeticNCT07271706
The Effect of Laughter Yoga in Type 2 Diabetes Patients
A study testing Laughter yoga in people with Diabetic and Laughter Yoga, run by Bozok University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Diabetic, Laughter Yoga, Comfort
- What is being tested?
- Laughter yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 25 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 diabetes
- Age 18 years or older
- Willingness to participate in the Laughter Yoga intervention
- Ability to read and comprehend Turkish
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic, Laughter Yoga, Comfort
- Being tested
- Laughter yoga
- Keywords
- laughter yoga, diabetic, comfort, self-governance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| Laughter yoga | Experimental | Not described Receives: Behavioral: Laughter yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Day 0) and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion25 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Bal, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271706
- Sponsor's protocol ID
- Yobu
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Self-management and Comfort in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT07271706
- Acronym / sponsor ID
- Yobu
- Conditions
- Diabetic, Laughter Yoga, Comfort
- Keywords
- laughter yoga, diabetic, comfort, self-governance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 25 Jan 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| Laughter yoga | Experimental | Behavioral: Laughter yoga |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Type 2 diabetes
- Age 18 years or older
- Willingness to participate in the Laughter Yoga intervention
- Ability to read and comprehend Turkish
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter yogaArm 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. | Behavioural | Laughter yoga |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter yoga in people with Diabetic and Laughter Yoga, run by Bozok University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Self-Management Score (Diabetes Self-Management Questionnaire - DSMQ) (time frame: Baseline (Day 0) and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.