DiabetesNCT06667804
The Effect of Laughter Yoga on Blood Glucose Level, Disease Perception and Stress Level in Patients With Type 2 Diabetes
A study testing Laughter yoga in people with Diabetes and Laughter Yoga, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Objective:This study was conducted to evaluate the effect of laughter yoga on postprandial blood glucose level, disease perception and perceived stress level in patients with Type 2 diabetes. Materials and Methods: The research was carried out as a randomized controlled trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Laughter Yoga, Glucose
- What is being tested?
- Laughter yoga
- 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 15 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 Any age
- All sexes
- No healthy volunteers
- Child, 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 Blood Glucose Level, Disease Perception and Stress Level in Patients With Type 2 Diabetes;Randomized Controlled Trial
Objective:This study was conducted to evaluate the effect of laughter yoga on postprandial blood glucose level, disease perception and perceived stress level in patients with Type 2 diabetes.
Materials and Methods: The research was carried out as a randomized controlled trial. The population of the study consisted of patients who were followed up with the diagnosis of Type 2 diabetes mellitus in a hospital located in western Turkey. The sample consisted of 100 patients (experimental group = 50, control group = 50) determined by power analysis. In the study, simple randomization was performed to assign patients to groups. Patient Introduction Form, The Brief Disease Perception Scale (B-IPQ), Perceived Stress Scale (PSS) and Blood Glucose Level Registration forms were used to collect data from the patients. The patients in the experimental group were made to do 8 sessions of laughter yoga. The experimental group received 8 sessions (each session lasted 30-45 minutes on average) of laughter yoga, 2 days a week for 4 weeks. Patients were asked to measure and record their blood glucose level before breakfast. The yoga session started 30 minutes after breakfast and after the session was completed, they were asked to measure and record their blood glucose levels again at 120 minutes after breakfast. Blood glucose levels of the patients in the control group were measured before and 2 hours after breakfast, 2 days a week.
Read the detailed description
Non-pharmacological methods, which are now widely used in nursing care, are accepted as a useful approach to reduce pain, stress and anxiety. In this study, the investigators focused on the therapeutic effect of laughter yoga in individuals with diabetes. In the literature, it has been determined that laughter reduces postprandial blood glucose levels, improves the clinical outcomes of disorders such as inflammation, asthma, cancer and heart disease, reduces anxiety and depression, and the reasons for this are the reduction of physiological stress response. In this study, it was thought that laughter yoga would have an effect on blood glucose value, disease perception and perceived stress level in individuals with Type 2 diabetes.
- Conditions
- Diabetes, Laughter Yoga, Glucose, Stress
- Being tested
- Laughter yoga
- Keywords
- Blood Glucose, Nursing, Laughter Yoga, Diabetes Mellitus, Stress
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaOther
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). - The researcher is certified as an International Leader of Laughter Yoga. As a nursing intervention, patients with T2DM were made to do laughter yoga by the researcher. The laughter yoga program was conducted online (Google meet online) due to the ongoing COVID-19 pandemic at the time of the study. - The sessions were organized as follows: Monday-Thursday 10:00-10:45, Tuesday-Friday 10:00-10:45, Wednesday-Saturday 10:00-10:45. Participants participated in two sessions that were suitable for them within a week. A participant in a group was not allowed to change days in the following weeks.
| Study group | Role | What they receive |
|---|---|---|
| Laughter yoga group | Experimental | Laughter yoga group Receives: Other: Laughter yoga |
| Control group | No intervention | No intervention was applied to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glukose level
Fasting blood glucose was measured before breakfast. Postprandial blood glucose was measured 2 hours after breakfast. Laughter yoga sessions were applied to the patients in the experimental group within this two-hour period.
Measured: two days a week for one month
Secondary outcomes (1)
Perception of Illness and Perceived Stress
Perception of Illness (The Brief Disease Perception Scale (B-IPQ)) and Perceived Stress (The Perceived Stress Scale (PSS)) level were collected as pre-test data when the study started. One month later, the scales were reapplied and post-test data were collected.
In the scoring of the Brief Disease Perception Scale (B-IPQ), 7 items are scored on a Likert-type scale between 0-10. A score between 0 and 70 can be obtained from the scale. As the score obtained from the scale increases, the person's threat perception towards the disease increases negatively.
A score between 0-56 can be obtained from the Perceived Stress Scale (PSS). There is no cut-off point in the scale, and a higher score indicates that the stress perception of the individual is high.
Measured: one month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start15 Jul 2022
- Primary completion15 Dec 2022
- Study completion15 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 DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cotrolled clinical trial
- Masking
- None (open label)
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667804
- Sponsor's protocol ID
- HAslan
- Other IDs
- Hakime Aslan
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aslan H, Akturk U. Demographic characteristics, nutritional behaviors, and orthorexic tendencies of women with breast cancer: a case-control study. Eat Weight Disord. 2020 Oct;25(5):1365-1375. doi: 10.1007/s40519-019-00772-y. Epub 2019 Sep 11.
PubMed 31512190
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Blood Glucose Level, Disease Perception and Stress Level in Patients With Type 2 Diabetes;Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06667804
- Acronym / sponsor ID
- HAslan
- Conditions
- Diabetes, Laughter Yoga, Glucose, Stress
- Keywords
- Blood Glucose, Nursing, Laughter Yoga, Diabetes Mellitus, 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 Dec 2022 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 31 Oct 2024 (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.
Objective:This study was conducted to evaluate the effect of laughter yoga on postprandial blood glucose level, disease perception and perceived stress level in patients with Type 2 diabetes.
Materials and Methods: The research was carried out as a randomized controlled trial. The population of the study consisted of patients who were followed up with the diagnosis of Type 2 diabetes mellitus in a hospital located in western Turkey. The sample consisted of 100 patients (experimental group = 50, control group = 50) determined by power analysis. In the study, simple randomization was performed to assign patients to groups. Patient Introduction Form, The Brief Disease Perception Scale (B-IPQ), Perceived Stress Scale (PSS) and Blood Glucose Level Registration forms were used to collect data from the patients. The patients in the experimental group were made to do 8 sessions of laughter yoga. The experimental group received 8 sessions (each session lasted 30-45 minutes on average) of laughter yoga, 2 days a week for 4 weeks. Patients were asked to measure and record their blood glucose level before breakfast. The yoga session started 30 minutes after breakfast and after the session was completed, they were asked to measure and record their blood glucose levels again at 120 minutes after breakfast. Blood glucose levels of the patients in the control group were measured before and 2 hours after breakfast, 2 days a week.
Detailed description
Non-pharmacological methods, which are now widely used in nursing care, are accepted as a useful approach to reduce pain, stress and anxiety. In this study, the investigators focused on the therapeutic effect of laughter yoga in individuals with diabetes. In the literature, it has been determined that laughter reduces postprandial blood glucose levels, improves the clinical outcomes of disorders such as inflammation, asthma, cancer and heart disease, reduces anxiety and depression, and the reasons for this are the reduction of physiological stress response. In this study, it was thought that laughter yoga would have an effect on blood glucose value, disease perception and perceived stress level in individuals with Type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cotrolled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Laughter yoga group | Experimental | Other: Laughter yogaLaughter yoga group |
| Control group | No intervention | –No intervention was applied to the patients in the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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). - The researcher is certified as an International Leader of Laughter Yoga. As a nursing intervention, patients with T2DM were made to do laughter yoga by the researcher. The laughter yoga program was conducted online (Google meet online) due to the ongoing COVID-19 pandemic at the time of the study. - The sessions were organized as follows: Monday-Thursday 10:00-10:45, Tuesday-Friday 10:00-10:45, Wednesday-Saturday 10:00-10:45. Participants participated in two sessions that were suitable for them within a week. A participant in a group was not allowed to change days in the following weeks. | Other | Laughter yoga group |
Primary outcome
Blood glukose level
Time frame: two days a week for one month
Fasting blood glucose was measured before breakfast. Postprandial blood glucose was measured 2 hours after breakfast. Laughter yoga sessions were applied to the patients in the experimental group within this two-hour period.
1 secondary outcome
Perception of Illness and Perceived Stress
Time frame: one month later
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 4 Nov 2024.
- Results publication: PubMed 31512190Aslan H, Akturk U. Demographic characteristics, nutritional behaviors, and orthorexic tendencies of women with breast cancer: a case-control study. Eat Weight Disord. 2020 Oct;25(5):1365-1375. doi: 10.1007/s40519-019-00772-y. Epub 2019 Sep 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Laughter Yoga, 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 4 Nov 2024. 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?
Blood glukose level (time frame: two days a week for one 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 NCT06667804, 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 4 Nov 2024.