NCT06667804

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.

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

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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 29, 2024

Last Update Submit

October 31, 2024

Conditions

Keywords

Blood GlucoseNursingLaughter YogaDiabetes MellitusStress

Outcome Measures

Primary Outcomes (1)

  • Blood glukose level

    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 Outcomes (1)

  • Perception of Illness and Perceived Stress

    one month later

Study Arms (2)

Laughter yoga group

EXPERIMENTAL

Laughter yoga group

Other: Laughter yoga

Control group

NO INTERVENTION

No intervention was applied to the patients in the control group.

Interventions

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.

Laughter yoga group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized cotrolled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2024

First Posted

October 31, 2024

Study Start

July 15, 2022

Primary Completion

December 15, 2022

Study Completion

August 15, 2023

Last Updated

November 4, 2024

Record last verified: 2024-10

Locations