Effects of Laughter Yoga on Fatigue, Sleep Quality and Psychological Well-Being in Patients With Multiple Sclerosis: A Randomized Controlled Trial

NCT06783413 | Completed

• 1 other identifier: GaziosmanpasaU- HMŞRLK-NK-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is planned to evaluate the effects of laughter yoga applied to patients with multiple sclerosis on fatigue, sleep quality and psychological well-being. Although there are studies in the national and international literature that separately address the effects of laughter therapy on fatigue, sleep quality and psychological well-being, no studies have been found that address the effects of laughter therapy on fatigue, sleep quality and psychological well-being in patients with multiple sclerosis. This study is expected to make a significant contribution to the literature as it is the first experimental study to evaluate the effects of laughter therapy and laughter yoga applied to patients with multiple sclerosis on fatigue, sleep quality and psychological well-being. It is also thought that this study can guide studies to be conducted with other parameters. This study is planned to evaluate the effects of laughter yoga applied to patients with multiple sclerosis on fatigue, sleep quality and psychological well-being. Research Hypothesis H1: Laughter yoga reduces the fatigue level of multiple sclerosis patients compared to the control group. H2: Laughter yoga increases the sleep quality of multiple sclerosis patients compared to the control group. H3: Laughter yoga increases the effect of laughter yoga on psychological well-being of multiple sclerosis patients compared to the control group. Variables of the Study Dependent Variables: Introductory Information Form, Fatigue Severity Scale-YSQ, Pittsburgh Sleep Quality Index (PSQI), Psychological Well-Being Scale (PWSS) and Expanded Disability Status Scale (EDSS) will be used. Independent Variables: Laughter Yoga

Conditions

Fatigue; Sleep Quality; Psychological Well-being; Multiple Sclerosis

Keywords

Multiple Sclerosis; Laughter Yoga; Fatigue; Sleep Quality; Psychological Well-Being; Nursing

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Change in fatigue levels measured using the Fatigue Severity Scale (FSS). Participants' fatigue scores will be assessed at baseline and at the end of 6 weeks to assess the effectiveness of laughter yoga.

  6 weeks

Secondary Outcomes (1)

• Sleep Quality

  6 weeks

Other Outcomes (1)

• Effect on Psychological Well-Being

  6 weeks

Study Arms (2)

Intervention Group( Laughter Yoga Group)

EXPERIMENTAL

This group will participate in laughter yoga sessions twice a week for 30 minutes. These sessions include breathing techniques, laughter exercises and relaxation activities. The intervention period is 6 weeks in total.

Behavioral: Intervention group (Laughter Yoga)

No Intervention (Control Group)

OTHER

Participants in the control group will undergo standard care procedures without receiving any intervention. The results will be evaluated for comparison purposes.

Other: Control group

Interventions

Intervention group (Laughter Yoga) BEHAVIORAL

Laughter yoga is a practice that includes physical laughing exercises and breathing techniques. Sessions will be conducted as group therapy with a trained guide. The intervention will be applied to evaluate changes in participants' fatigue, sleep quality and psychological well-being.

Intervention Group( Laughter Yoga Group)

Control group OTHER

Participants in the control group will continue to receive their current standard of care and will not receive any additional interventions.

No Intervention (Control Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between the ages of 18-65
• Being literate
• Being diagnosed with MS
• Not having had an attack in the last month
• Being under 6.5 on the Expanded Disability Status Scale (EDSS)
• Not having a diagnosis of cognitive or mental disorder
• Being willing to participate in the study
• The patient has internet access
• Not having incontinence

You may not qualify if:

• Having a diagnosis of cognitive or mental disorder
• Having communication problems
• Having previously experienced laughter yoga
• Having a history of surgery in the last 3 months

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead
• Ataturk University: collaborator

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, 60500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Interventions

Laughter Therapy; Control Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which group they are in. The person who analyzes the data obtained at the end of the study will not know
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Randomized-controlled

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: April 15, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (1)