Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women

Официальное название

Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia: Protocol of a Randomized Clinical Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Pelvify: Menopause and dyspareunia treatment
  Topics addressed in the Asynchronous Online Telerehabilitation Program would be: 1. What it is and why it hurts during sex. What is dyspareunia? 2. How to recover vaginal elasticity. 3. Massage 4. Self-palpation. 5. Stretching of the pelvic floor muscles. 6. Use of vaginal dilators. 7. Moisturizers and lubricants. 8. Sexual pleasure. 9. Communication with the partner.
• Другое Face to Face Physical Therapy Protocol
  Physical Therapy Protocol will be based on: 1. Health education: 2. CMRF: INDIBA® ACTIV CT8 will be used to apply the radiofrequency 3. Manual therapy: it will be based on performing the Thiele's massage. 4. Vaginal dilators: FEMINAFORM® vaginal dilators will be used.
• Другое Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program
  Both, the face to face protocol and the Asynchronous Telerehabilitation Program will be carried on on this group.

Первичные конечные точки

• Improved Female Sexual Function via Female Sexual Function Index (FSFI) [Срок оценки: 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]
• Reduction in the Intensity of Dyspareunia Pain via Visual Analogue Scale (VAS) [Срок оценки: From enrollment to the end of treatment at 5 weeks, one week after treatment, and at six months and twelve months post treatment]
• Improved Quality of Life via Menopause Specific Quality of Life Questionnaire (MENQOL) [Срок оценки: 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]

Вторичные конечные точки (1)

• Change from the size of the Vaginal Dilator inserted without pain [Срок оценки: From enrollment to one week after treatment]

Критерии участия

Критерии включения

• Female
• Age from 45 to 65 years.
• Menopausal
• Suffer dyspareunia for 3 months of evolution.
• Willing to complete study questionnaires and informed consent study.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• RAPbarcelona — Barcelona

Публикации

• Marino JM. Genitourinary Syndrome of Menopause. J Midwifery Womens Health. 2021 Nov;66(6):729-739. doi: 10.1111/jmwh.13277. Epub 2021 Aug 31. PMID 34464022

Идентификаторы

NCT: NCT06710002 · RAPbarcelonaPAULA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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