The Effect of Laughter Yoga on Blood Glucose Level, Disease Perception and Stress Level in Patients With Type 2 Diabetes

NCT ID: NCT06667804

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-08-15

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.

Conditions

Diabetes; Laughter Yoga; Glucose; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Laughter yoga group

Laughter yoga group

Group Type: EXPERIMENTAL

Laughter yoga

Intervention Type: OTHER

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Laughter yoga

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Hakime Aslan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Inonu University

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 31512190 (View on PubMed)

Other Identifiers

Hakime Aslan

Identifier Type: OTHER

Identifier Source: secondary_id

HAslan

Identifier Type: -

Identifier Source: org_study_id