NCT06783608

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 14, 2025

Last Update Submit

January 20, 2025

Conditions

Keywords

Blood GlucoseDiabetes MellitusLaughter YogaNursingStress

Outcome Measures

Primary Outcomes (1)

  • The effect of Laghter yoga on blood glucose value

    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

Secondary Outcomes (1)

  • The effect of Laghter yoga on disease perception

    1 month

Other Outcomes (1)

  • The effect of Laghter yoga on percived stress

    1 month

Study Arms (2)

Laughter yoga group

EXPERIMENTAL

Laughter yoga

Behavioral: Laughter yoga

Control group

NO INTERVENTION

No intervention

Interventions

Laughter yogaBEHAVIORAL

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.

Laughter yoga group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hakime Aslan

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 33947501BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Hakime Aslan

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

July 15, 2022

Primary Completion

January 15, 2023

Study Completion

August 20, 2023

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations