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临床试验/NCT06805331
NCT06805331已完成不适用

The Effect of Health Belief Model-Based Pelvic Floor Muscle Exercise Training on Urinary Incontinence and Quality of Life in Female Patients With Multiple Sclerosis

Nurgül KAPLAN1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年4月9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
发起方
入组人数
46
试验地点
1
主要终点
Urinary Incontinence

研究概览

简要总结

The aim of this study is to evaluate the effect of Pelvic Floor Muscle Exercise Training According to the Health Belief Model on Urinary Incontinence and Quality of Life in Female Patients with Multiple Sclerosis.

Hypothesis 01: Pelvic floor muscle exercise training applied using the health belief model is not effective in reducing urinary complaints in female MS patients.

Hypothesis 1: Pelvic floor muscle exercise training applied using the health belief model is effective in reducing urinary complaints in female MS patients.

Hypothesis 02: Pelvic floor muscle exercise training applied using the health belief model is not effective on the quality of life of female MS patients.

Hypothesis 2: Pelvic floor muscle exercise training applied using the health belief model is effective on the quality of life of female MS patients.

详细描述

This study will be conducted to evaluate the effect of pelvic floor muscle exercise (PFMT) training on urinary incontinence and quality of life in women with multiple sclerosis (MS) according to the health belief model (HBM). This study will be conducted as a randomized controlled experimental study with 46 women with urinary incontinence complaints who were diagnosed with MS and followed up at the MS outpatient clinic of the Neurology Department of Tokat Gaziosmanpaşa University Hospital. Patients will be included in the control (23) and intervention (23) groups by simple randomization method. In collecting the research data; Questionnaire on Descriptive Characteristics, International Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life Scale (I-QOL), Incontinence Severity Index (ISI), Broome Pelvic Floor Muscle Exercise Self-Efficacy Scale (Broome PMSES), Expanded Disability Status Scale (EDSS), Bladder diary will be used. The research data will be collected after the experimental and control groups are determined after the approval. Data collection forms will be applied to both groups at the beginning of the study and at the end of the 1st and 3rd months. Patients in the intervention group will perform pelvic floor muscle exercises 3 times a day (morning-afternoon-evening) for 3 months. No intervention will be applied to patients in the control group. The data will be entered into a statistical package program and evaluated. No study has been found in the literature evaluating the effect of PTCE training according to the SIM on urinary incontinence and quality of life in female patients with MS. The research has original value in this respect and will contribute scientifically to national and international literature. If the research is successful, it is thought that PTCE training according to the health belief model in female patients with MS will be proven as a non-pharmacological intervention and will provide a new nursing intervention in the field. PTCE training according to the SIM in female patients with MS will reduce urinary incontinence and increase quality of life. In addition, it is thought that it will contribute positively to the physiological, psychological and social recovery process of MS patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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 the groups.

入排标准

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

入选标准

  • •Being 18 years old and above,
  • •Being a woman,
  • •Being diagnosed with MS,
  • •Having urinary incontinence,
  • •Not having an attack in the last thirty days,
  • •No change in medical treatment in the last three months,
  • •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,

排除标准

  • •Presence of pregnancy,
  • •Presence of urinary tract infection,
  • •Presence of another neurological disease that may cause incontinence,
  • •History of cancer,
  • •History of pelvic surgery,
  • •Presence of pelvic organ prolapse,
  • •Deficiency in evaluation parameters,
  • •Non-compliance with treatment programs,
  • •Change in drug treatment during treatment,
  • •Receiving PTCE in the last six months

研究组 & 干预措施

Intervention Group (Pelvic Floor Muscle Exercise Training)

Experimental

The researcher will explain pelvic floor muscle exercises to the patients within the framework of the health belief model. After the pelvic floor muscle exercise training is given, the patients will be asked to do these exercises three times a day (morning-afternoon-evening) for three months (12 weeks).

干预措施: Intervention group(Pelvic Floor Muscle Exercise Training) (Behavioral)

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.

干预措施: control group (Other)

结局指标

主要结局

Urinary Incontinence

时间窗: Three months

Urinary incontinence severity and impact will be assessed at baseline and after 3 months using the International Incontinence Questionnaire Short Form (ICIQ-SF).

次要结局

  • Quality of life in Women with Multiple Sclerosis(Three months)

研究者

发起方
Nurgül KAPLAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nurgül KAPLAN

Instructor

Tokat Gaziosmanpasa University

研究点 (1)

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