Laughter Yoga for Improving Sexual Function and Psychosocial Outcomes in Multiple Sclerosis

NCT06947434 | Completed

• 1 other identifier: 2022/352
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether laughter yoga can improve sexual functioning and reduce psychological symptoms in adults diagnosed with multiple sclerosis (MS). The main questions it aims to answer are: Does laughter yoga improve sexual functioning in individuals with MS? Does laughter yoga reduce anxiety, depression, and fatigue, and improve quality of life in this population? Participants will: Attend 10 online laughter yoga sessions over 5 weeks (2 sessions per week, 40 minutes each) Complete online questionnaires before, during, and after the intervention to assess sexual functioning, anxiety, depression, fatigue, and quality of life

Conditions

Multiple Sclerosis; Sexual Dysfunction

Keywords

multiple sclerosis; sexual life; anxiety; depression; quality of life; laughter yoga

Outcome Measures

Primary Outcomes (1)

• Change in Sexual Functioning (MSISQ-19 Total Score)

  Sexual functioning will be assessed using the Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 (MSISQ-19). This scale includes 19 items measuring primary, secondary, and tertiary sexual dysfunctions in individuals with MS. Scores range from 19 to 95, with higher scores indicating greater dysfunction. A reduction in score reflects improvement in sexual functioning.

  Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)

Secondary Outcomes (2)

• Change in Anxiety Level (HADS-A Score)

  Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)

• Change in Fatigue Level (Fatigue Severity Scale Score)

  Baseline (Week 0), Pre-Intervention (Week 5), and Post-Intervention (Week 11)

Study Arms (1)

Single Arm

EXPERIMENTAL

Participants in this single-arm study will undergo a structured laughter yoga intervention after a 5-week observation period without any intervention. The intervention consists of 10 sessions delivered over the subsequent 5 weeks (2 sessions per week). Each session lasts approximately 40 minutes and is conducted online via Zoom. Sessions include four core components: rhythmic clapping, deep breathing exercises (pranayama), playful activities, and guided laughter exercises. This design allows within-subject comparison of outcomes before and after the intervention. The goal is to assess the effects of laughter yoga on sexual functioning and psychological well-being in individuals with multiple sclerosis.

Other: Laughter Yoga

Interventions

Laughter Yoga OTHER

Laughter yoga is a behavioral intervention that combines intentional laughter exercises with yogic breathing techniques. In this study, the intervention consisted of 10 sessions delivered over five weeks (two sessions per week), each lasting approximately 40 minutes. Sessions were conducted live via Zoom and included components such as rhythmic clapping, deep breathing (pranayama), playful movements, and guided laughter exercises. The aim was to promote relaxation, reduce stress, and enhance psychological well-being in individuals with multiple sclerosis.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Diagnosed with multiple sclerosis (MS)
• Literate and able to complete self-report questionnaires
• Expanded Disability Status Scale (EDSS) score \< 4
• HADS-Anxiety score \> 10
• HADS-Depression score \> 7
• Reporting sexual problems based on MSISQ-19
• Having an active sexual life
• Access to internet and a device capable of video conferencing
• Willing to participate and able to attend all 10 laughter yoga sessions

You may not qualify if:

• MS relapse or acute exacerbation within the last 3 months
• Severe cognitive impairment or communication difficulties
• Current participation in any laughter therapy, yoga, or similar psychosocial intervention
• Diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder)
• Unwillingness or inability to provide informed consent

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University School Of Nursing

Istanbul, 34116, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Sexual Dysfunction, Physiological; Anxiety Disorders; Depression

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Genital Diseases; Urogenital Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant Professor

Model Details: This study utilizes a single-group pretest-posttest quasi-experimental design to evaluate the effects of a structured laughter yoga intervention on psychological symptoms (anxiety and depression), fatigue, sexual life, and quality of life in individuals with multiple sclerosis (MS). The model includes three data collection points: baseline (Week 0), five weeks after the pretest (Week 5, without intervention), and post-intervention (Week 11, after 10 laughter yoga sessions). This within-subject design allows for the comparison of participant outcomes over time, enabling the assessment of changes attributable to the intervention. No control group is included in this design.

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 27, 2025
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)