- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06783608
Laughter Yoga on Blood Glucose Levels, Disease Perception and Perceived Stress Level
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".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Malatya, Turkey, 44280
- Hakime Aslan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
No intervention
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Experimental: Laughter yoga group
Laughter yoga
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The effect of Laghter yoga on blood glucose value
Time Frame: 1 month
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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 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of Laghter yoga on disease perception
Time Frame: 1 month
|
'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. |
1 month
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The effect of Laghter yoga on percived stress
Time Frame: 1 month
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The Perceived Stress Scale (PSS) was used to evaluate the stress perceived by diabetic patients. During the data collection process, the scale was applied to patients in both groups and pre-test data were collected. One month later, the scale was applied again and the change in perceived stress was evaluated. The Perceived Stress Scale (PSS) The Perceived Stress Scale (PSS) was developed by Cohen, Kamarck, and Mermelstein. The Turkish validation and reliability of the scale was conducted by Eskin and colleagues. This tool includes 14 questions that assess individuals' perception of stress in various scenarios in their life. Using a five-point Likert scale, responses range from 0 (never) to 4 (very often). Scores between 0-56 can be obtained from the scale. There is no cut-off point in the scale, and an increase in the score indicates that the stress perception of the individual is high. |
1 month
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hakime Aslan, Inonu University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Abdurrahman Akçin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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