Clinical trial NCT06667804: The Effect of Laughter Yoga on Blood Glucose Level, Disease Perception and Stress Level in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Laughter Yoga
Glucose
Stress
Keywords: Blood Glucose
Nursing
Laughter Yoga
Diabetes Mellitus
Stress
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized cotrolled clinical trial
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood glukose level
timeFrame: two days a week for one month
Secondary outcomes:
measure: Perception of Illness and Perceived Stress
timeFrame: one month later
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
References:
citation: 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.