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临床试验/NCT06947434
NCT06947434已完成不适用

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

Istanbul University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Change in Sexual Functioning (MSISQ-19 Total Score)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Laughter Yoga (Other)

结局指标

主要结局

Change in Sexual Functioning (MSISQ-19 Total Score)

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cansu POLAT DÜNYA

PhD, Assistant Professor

Istanbul University

研究点 (1)

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