Telerehabilitation program for improving sexual function and reducing pain in menopausal women
Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women With Dyspareunia: Protocol of a Randomized Clinical Trial.
This study is testing a telerehabilitation program to see if it can help menopausal women with painful sex feel better and improve their overall quality of life compared to regular in-person therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | Instituto Médico Tecnológico SL Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barcelona, Spain) |
| Trial ID | NCT06710002 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a telerehabilitation program compared to traditional face-to-face physiotherapy for menopausal women experiencing dyspareunia. It will assess improvements in sexual function, pain reduction, and quality of life using validated instruments such as the Female Sexual Function Index and the Visual Analogue Scale. The study will also explore the potential benefits of combining telerehabilitation with in-person treatment and monitor adherence and satisfaction levels among participants.
Who should consider this trial
Good fit: Ideal candidates are menopausal women aged 45 to 65 who have been experiencing dyspareunia for at least three months.
Not a fit: Patients with certain medical conditions, such as active cancer or neuromuscular diseases, or those who have undergone recent pelvic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide a convenient and effective treatment option for menopausal women suffering from sexual dysfunction and pain.
How similar studies have performed: While telerehabilitation has shown promise in various health fields, this specific approach comparing it to face-to-face physiotherapy in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age from 45 to 65 years. * Menopausal * Suffer dyspareunia for 3 months of evolution. * Willing to complete study questionnaires and informed consent study. Exclusion Criteria: * 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.
Where this trial is running
Barcelona, Spain
- RAPbarcelona — Barcelona, Spain, Spain (Recruiting)
Study contacts
- Study coordinator: Paula Sanfeliu Rosell, MSc
- Email: fisiopaulasanfeliu@gmail.com
- Phone: +34 648222751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.