Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia: Protocol of a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Improved Female Sexual Function via Female Sexual Function Index (FSFI)
研究概览
简要总结
The aim of this study is to analyze the effectiveness of a telerehabilitation program with respect to a face-to-face physiotherapy protocol in relation to the improvement of sexual function, the reduction of pain and the improvement of the quality of life, in the treatment of menopausal women with dyspareunia.
详细描述
Both therapies have been proven to be effective, but since now any randomized controlled trial has been conducted to compare the results regarding the improvement in the sexual function, the reduction of pain and the improvement of quality of life in this population. The investigators hypothesize that the implementation of an asynchronous online telerehabilitation program is not inferior to the effect of the treatment carried out with a face-to-face physiotherapy protocol, in relation to the main variables obtained with the instruments Female Sexual Function Index (FSFI), the Visual Analogue Scale (VAS) and Menopause Specific Quality of Life Questionnaire (MENQOL). Secondary goals are: 1) to evaluate whether the incorporation of a telerehabilitation program to face-to-face treatment increases the effectiveness in relation to performing only the face-to-face physiotherapy protocol, 2) compare the size of the vaginal dilator inserted painlessly at the end of the treatment in all groups, 3) identify any adverse effects associated with the intervention during the study, 4) detail the degree of adherence to the treatment and 5) record satisfaction with the treatment using the Likert Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 45 to 65 years.
- •Menopausal
- •Suffer dyspareunia for 3 months of evolution.
- •Willing to complete study questionnaires and informed consent study.
排除标准
- •Pacemaker or other types of electronic implant.
- •Thrombophlebitis.
- •Skin hypersensitivity or rejection of manual contact.
- •Active or previous treatment with chemotherapy or radiotherapy in the pelvic area.
- •Wounds or burns in the pelvic area.
- •Allergy to nickel and chromium.
- •Other pelvic floor physiotherapy treatments during the study intervention.
- •Other medical and surgical treatments in the pelvic region, such as muscle infiltrations or nerve blocks during the study intervention.
- •Surgical intervention in the pelvic area in the last 3 months.
- •Fibromyalgia.
- •Oncological processes that affect the sacrum.
- •Systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
- •Neuromuscular diseases (Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Myasthenia Gravis or spinal muscular atrophy).
- •Myelopathy and Osteomyelitis.
- •Diseases that cause alterations of the central nervous system (traumatic or vascular spinal cord injury).
- •Neurological or metabolic conditions that affect the ability to respond (Diabetes, Parkinson's disease, senile dementia, etc).
- •Serious mental disorder.
结局指标
主要结局
Improved Female Sexual Function via Female Sexual Function Index (FSFI)
时间窗: From registration to the end of treatment at 5 weeks, one week after the end of treatment, and at 6 and 12 months post-treatment
FSFI it is a self-administered instrument made up of 19 questions grouped into 6 domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Response is measured on a scale from 0 (no sexual activity) to 5 (almost always). The FSFI total score range is 2 to 36; a score of less than or equal to 26.55 points, or when the score of any domain is less than 3.6 points, is considered a risk criterion for sexual dysfunction.
Reduction in the Intensity of Dyspareunia Pain via Visual Analogue Scale (VAS)
时间窗: From enrollment to the end of treatment at 5 weeks, one week after treatment, and at six months and twelve months post treatment
This scale (VAS) adequately captures the intensity of pain perceived by the patient represented by a horizontal line of 10 cm, where the left end (0 cm) is the absence of pain and the right end (10 cm) is pain of maximum intensity possible. The patient is asked to mark on the line the point indicating the intensity of their pain and it is measured with a millimeter ruler. The intensity is expressed in centimeters. It is considered mild up to 4 cm, moderate from 5 to 7 cm and if it is greater than 7 cm.
Improved Quality of Life via Menopause Specific Quality of Life Questionnaire (MENQOL)
时间窗: From registration to the end of treatment at 5 weeks, one week after the end of treatment, and at 6 and 12 months post-treatment
MENQOL it is a questionnaire designed to assess the quality of life of women who are going through menopause. It consists of 29 questions grouped into 4 domains: vasomotor area, psychosocial area, physical area and sexual area. Each question has two answer options No/Yes, if yes, it is assigned a score ranging from 0 (not annoying) to 6 (very annoying). The total score is from 29 to 232 points. A higher score indicates more intense symptomatology.
次要结局
- Change from the size of the Vaginal Dilator inserted without pain(From enrollment to one week after treatment)
研究者
Inés Ramírez García
Principal Investigator. Professor. Physiotherapist PhD
University Ramon Llull