Clinical trial NCT06783608: Laughter Yoga on Blood Glucose Levels, Disease Perception and Perceived Stress Level
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Blood Glucose
Diabetes Mellitus
Laughter Yoga
Nursing
Stress
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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: The effect of Laghter yoga on blood glucose value
timeFrame: 1 month
Secondary outcomes:
measure: The effect of Laghter yoga on disease perception
timeFrame: 1 month
Other outcomes:
measure: The effect of Laghter yoga on percived stress
timeFrame: 1 month
Locations:
city: Malatya
country: Turkey
facility: Hakime Aslan
Study officials:
affiliation: Inonu University
name: Hakime Aslan
role: STUDY_DIRECTOR
References:
citation: 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.