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Completed

NCT Number: NCT06947434

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

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

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Key information

Conditions

Multiple Sclerosis Anxiety Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Genital Diseases Immune System Diseases Mental Disorders Nervous System Diseases Sexual Dysfunction Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University School Of Nursing

Istanbul, 34116, Turkey (Türkiye)

About this study

This quasi-experimental study investigates the effectiveness of laughter yoga in improving sexual functioning and psychosocial outcomes in adults with multiple sclerosis (MS). Laughter yoga is a behavioral intervention combining voluntary laughter with yogic breathing techniques, aiming to enhance emotional well-being and reduce stress-related symptoms.

The study includes three assessment points: baseline (pretest), five weeks after the baseline (pre-intervention), and post-intervention. The intervention consists of 10 structured laughter yoga sessions conducted via Zoom over a 5-week period. Each session lasts approximately 40 minutes and includes rhythmic clapping, deep breathing exercises, playful activities, and simulated laughter practices guided by a certified laughter yoga facilitator.

Validated self-report instruments are used to assess sexual functioning, anxiety, depression, fatigue, and quality of life. The study specifically targets individuals with MS who report sexual problems and experience mild to moderate psychological symptoms.

The primary aim is to determine the effect of laughter yoga on sexual functioning (measured by MSISQ-19). Secondary outcomes include changes in anxiety, depression, fatigue, and health-related quality of life. This study seeks to explore laughter yoga as a feasible, non-pharmacological, and low-cost approach to improving multidimensional well-being in MS patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in Sexual Functioning (MSISQ-19 Total Score)

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

    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.

Secondary outcomes

  1. Change in Anxiety Level (HADS-A Score)

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

    Anxiety levels will be measured using the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). Scores range from 0 to 21, with higher scores indicating greater anxiety. A decrease in the score reflects improvement.

  2. Change in Fatigue Level (Fatigue Severity Scale Score)

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

    Fatigue will be assessed using the Fatigue Severity Scale (FSS), consisting of 9 items rated on a scale from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater fatigue. A mean score ≥4 indicates clinically significant fatigue.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Effects of Laughter Yoga on Sexual Functioning, Anxiety, Depression, Fatigue, and Quality of Life in Patients With Multiple Sclerosis: A Quasi-Experimental Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 27, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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