- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06667804
The Effect of Laughter Yoga on Blood Glucose Level, Disease Perception and Stress Level in Patients With Type 2 Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Malatya, Turkey, 44280
- Inonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- 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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laughter yoga group
|
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.
|
|
No Intervention: Control group
No intervention was applied to the patients in the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
two days a week for one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perception of Illness and Perceived Stress
Time Frame: one month later
|
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. |
one month later
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAslan
- Hakime Aslan (Other Identifier: Inonu University)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of Colorado, DenverMassachusetts General Hospital; Ann & Robert H Lurie Children's Hospital of... and other collaboratorsRecruitingDiabetes Mellitus | Diabetes | Type 2 Diabetes | Diabetes Mellitus Type 2 | Diabetes Mellitus, Type I | Diabetes Mellitus Type II | Diabetes Mellitus, Insulin-Dependent | Diabetes, Autoimmune | Type 1 Diabetes (T1D) | Diabetes Type 2 on Insulin | Diabetes, Type IIUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of North Carolina, Chapel HillAmerican Diabetes AssociationNot yet recruitingType 2 Diabetes Mellitus (T2DM) | Diabetes (DM) | Insulin Dependent Diabetes | Type 1 Diabetes (T1D) | Diabetes Education | Diabetes Care | Diabetes (Insulin-requiring, Type 1 or Type 2)United States
-
Cairo UniversityNot yet recruitingDiabetes Complication
-
University of North Carolina, Chapel HillAmerican Heart AssociationRecruitingType 2 Diabetes | Nutrition | Diabetes Type 2 | T2DM (Type 2 Diabetes Mellitus) | Diabetes Mellitis | T2DM | Diabetes EducationUnited States
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
COUR Pharmaceutical Development Company, Inc.RecruitingType 1 Diabetes | Type 1 Diabetes Mellitus | T1DM | T1D | Type 1 Diabetes in Adolescence | Type 1 Diabetes in Children | Type 1 Diabetes Patients | Type 1 Diabetes Mellitis | T1DM - Type 1 Diabetes Mellitus | Type 1 Diabetes (Juvenile Onset)United States
Clinical Trials on Laughter yoga
-
Ataturk UniversityKTO Karatay UniversityRecruiting
-
Artvin Coruh UniversityAtaturk UniversityRecruiting
-
Mersin UniversityCompletedSleep | Vasomotor; SyndromeTurkey
-
Adiyaman University Research HospitalCompletedDepression | Stress | Anxiety | Psychological ResilienceTurkey
-
Mersin UniversityNot yet recruitingQuality of Life | Premenstrual Syndrome
-
Ataturk UniversityCompleted
-
Muğla Sıtkı Koçman UniversityNot yet recruitingLaughter Yoga | Haemodialysis PatientsTurkey
-
Pamukkale UniversityNot yet recruitingPremenstrual Syndrome | Laughter
-
Izmir Democracy UniversityCompletedSpirituality | Laughter Yoga | Spiritual Well-beingTurkey
-
Ataturk UniversityActive, not recruiting