Diabetes Mellitus, Type 2NCT06783608
Laughter Yoga on Blood Glucose Levels, Disease Perception and Perceived Stress Level
A study testing Laughter yoga in people with Diabetes Mellitus, Type 2, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Aim This study was conducted to evaluate the effect of laughter yoga on blood glucose level, disease perception and perceived stress level in patients with Type 2 diabetes mellitus. Method The study was conducted using a randomized controlled experimental design with a pre-test and post-test. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- 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
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 20 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with T2DM for at least 6 months,
- Able to use computer and/or mobile applications,
- At least primary education graduate,
- Using oral antidiabetic drugs,
- No diagnosed psychiatric illness,
- No communication problems,
- Patients who volunteered to participate in the study were included.
Who cannot join
- Using Parenteral Insulin,
- The one who doesn't attend all the yoga sessions,
- Patients with physical conditions that prevent them from participating in laughter yoga sessions (respiratory distress, persistent cough, veritgo, severe heart disease, hemeroid, hernia of any kind, severe back pain, urinary incontinence, epilepsy, bleeding tendency, thrombocytopenia and deformity visible on examination),
- Patients taking medication or other nonpharmacological methods to reduce stress,
- Patients who did not want to participate in the study were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga on Postprandial Blood Glucose Levels, Disease Perception and Perceived Stress Level in Patients With Type 2 Diabetes Mellitus: Randomized Controlled Trial
Aim This study was conducted to evaluate the effect of laughter yoga on blood glucose level, disease perception and perceived stress level in patients with Type 2 diabetes mellitus.
Method The study was conducted using a randomized controlled experimental design with a pre-test and post-test. The population of the study was followed up with the diagnosis of Type 2 diabetes mellitus (T2DM) in the endocrine outpatient clinics of a hospital in the western region of Turkey. The sample consisted of 100 patients (laughter yoga group=50, control group=50) determined by power analysis. Participants were assigned to each group through a process of simple randomization. Data collection was facilitated using a "Patient Identification Form,", "The Brief Disease Perception Scale," and " The Perceived Stress Scale".
Read the detailed description
During the research process, in the laughter yoga group participated in eight laughter yoga sessions. while the patients in the control group continued to receive routine care practices.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Laughter yoga
- Keywords
- Blood Glucose, Diabetes Mellitus, Laughter Yoga, Nursing, Stress
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaBehavioural
Laughter yoga was applied to the experimental group for 4 weeks, 2 days a week, for 8 sessions (each session duration is 30-45 minutes on average). Patients were asked to measure and record their blood glucose value before breakfast. The yoga session was started 30 minutes after breakfast, and after the session was completed, they were asked to measure and record their blood glucose value again at 120 minutes after breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Laughter yoga group | Experimental | Laughter yoga Receives: Behavioral: Laughter yoga |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Laghter yoga on blood glucose value
Blood glucose follow-up charts were given to the patients and they were informed about the measurement times. In this study, the blood glucose measurement of the patients was before breakfast and after the sessions (after breakfast in the control group). Postprandial blood glucose (2-hour postprandial) was performed twice. Measurements were measured from fingertips by enzyme colorimetric assay using a blood glucose meter by the individuals themselves.
Patients were asked to measure and record their blood glucose level before breakfast. The yoga session was started 30 minutes after breakfast, and after the session was completed, they were asked to measure and record their blood glucose level again at 120 minutes after breakfast.
Measured: 1 month
Secondary outcomes (1)
The effect of Laghter yoga on disease perception
'The Brief Disease Perception Scale (B-IPQ)' was used to evaluate how diabetic patients perceive the disease. During the data collection process, the scale was applied to the patients in both groups and pre-test data were collected. One month later, the scale was applied again and the change in disease perceptions was evaluated.
The Brief Disease Perception Scale (B-IPQ) The Brief Illness Perception Questionnaire (B-IPQ), developed by Broadbent and colleagues, examines how individuals perceive their illness. It comprises nine items. Each item investigates a different aspect of illness perception. Respondents are asked to rate each item on a scale from 0 to 10. The Turkish version of the B-IPQ was validated and deemed reliable by Karataş and others in 2017.Scores between 0 and 80 can be obtained from the scale. As the disease perception score increases, the level of being affected by the disease and the level of seeing the disease as worrying also increases.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Jul 2022
- Primary completion15 Jan 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakime Aslan, Inonu University
- Investigators
- Hakime Aslan, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783608
- Sponsor's protocol ID
- Abdurrahman Akçin
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aslan H, Erci B. The effect of playing games with toys made with medical materials in children with cancer on pain during intravenous treatment. Palliat Support Care. 2022 Feb;20(1):84-93. doi: 10.1017/S1478951521000390.
PubMed 33947501
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Postprandial Blood Glucose Levels, Disease Perception and Perceived Stress Level in Patients With Type 2 Diabetes Mellitus: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06783608
- Acronym / sponsor ID
- Abdurrahman Akçin
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Blood Glucose, Diabetes Mellitus, Laughter Yoga, Nursing, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 20 Jan 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.
Aim This study was conducted to evaluate the effect of laughter yoga on blood glucose level, disease perception and perceived stress level in patients with Type 2 diabetes mellitus.
Method The study was conducted using a randomized controlled experimental design with a pre-test and post-test. The population of the study was followed up with the diagnosis of Type 2 diabetes mellitus (T2DM) in the endocrine outpatient clinics of a hospital in the western region of Turkey. The sample consisted of 100 patients (laughter yoga group=50, control group=50) determined by power analysis. Participants were assigned to each group through a process of simple randomization. Data collection was facilitated using a "Patient Identification Form,", "The Brief Disease Perception Scale," and " The Perceived Stress Scale".
Detailed description
During the research process, in the laughter yoga group participated in eight laughter yoga sessions. while the patients in the control group continued to receive routine care practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter yoga group | Experimental | Behavioral: Laughter yogaLaughter yoga |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with T2DM for at least 6 months,
- Able to use computer and/or mobile applications,
- At least primary education graduate,
- Using oral antidiabetic drugs,
- No diagnosed psychiatric illness,
Key exclusion criteria (5 listed)
- Using Parenteral Insulin,
- The one who doesn't attend all the yoga sessions,
- Patients with physical conditions that prevent them from participating in laughter yoga sessions (respiratory distress, persistent cough, veritgo, severe heart disease, hemeroid, hernia of any kind, severe back pain, urinary incontinence, epilepsy, bleeding tendency, thrombocytopenia and deformity visible on examination),
- Patients taking medication or other nonpharmacological methods to reduce stress,
- Patients who did not want to participate in the study were excluded.
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 yogaLaughter yoga was applied to the experimental group for 4 weeks, 2 days a week, for 8 sessions (each session duration is 30-45 minutes on average). Patients were asked to measure and record their blood glucose value before breakfast. The yoga session was started 30 minutes after breakfast, and after the session was completed, they were asked to measure and record their blood glucose value again at 120 minutes after breakfast. | Behavioural | Laughter yoga group |
Primary outcome
The effect of Laghter yoga on blood glucose value
Time frame: 1 month
Blood glucose follow-up charts were given to the patients and they were informed about the measurement times. In this study, the blood glucose measurement of the patients was before breakfast and after the sessions (after breakfast in the control group). Postprandial blood glucose (2-hour postprandial) was performed twice. Measurements were measured from fingertips by enzyme colorimetric assay using a blood glucose meter by the individuals themselves. Patients were asked to measure and record their blood glucose level before breakfast. The yoga session was started 30 minutes after breakfast, and after the session was completed, they were asked to measure and record their blood glucose level again at 120 minutes after breakfast.
1 secondary outcome
The effect of Laghter yoga on disease perception
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 33947501Aslan H, Erci B. The effect of playing games with toys made with medical materials in children with cancer on pain during intravenous treatment. Palliat Support Care. 2022 Feb;20(1):84-93. doi: 10.1017/S1478951521000390.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hakime Aslan study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter yoga in people with Diabetes Mellitus, Type 2, run by Inonu University at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effect of Laghter yoga on blood glucose value (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06783608, which also lists 1 linked publication.
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 22 Jan 2025.