About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Age from 45 to 65 years.
Menopausal
Suffer dyspareunia for 3 months of evolution.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Pelvify: Menopause and dyspareunia treatment
BehavioralTopics 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.
Face to Face Physical Therapy Protocol
Other interventionPhysical 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.
Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program
Other interventionBoth, the face to face protocol and the Asynchronous Telerehabilitation Program will be carried on on this group.
Treatment groups
Trial outcomes
Primary outcomes
Improved Female Sexual Function via Female Sexual Function Index (FSFI)
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)
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)
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.
Secondary outcomes
Change from the size of the Vaginal Dilator inserted without pain
It will be measured with FEMINAFORM® vaginal dilators. The set consists of 4 dilators of different diameters and lengths, and a clamping device: Size 1: 22mmx85mm (diameter/length), Size 2: 27x105mm (diameter/length), Size 3: 32x135mm (diameter/length) and Size 4 : 37x160mm (diameter/length). The largest vaginal dilator size that has a score (VAS) of 0 cm will be recorded. It will be specified whether the absence of pain is by inserting the entire dilator or only a part.
Other outcomes
Number of complaints or adverse effects registered during treatments
Any type of discomfort or alteration of normality during the application or after the end of the treatment, will be recorded
Degree of Satisfaction Score on the treatment using the Likert Scale.
The six-point Likert Scale is a psychometric measurement tool that assesses subjective attitudes and opinions. Each level of the scale is given a numerical value. It will be expressed as: 1 = Strongly Disagree, 2 = Disagree, 3 = Slightly Disagree, 4 = Slightly Agree, 5 = Agree and 6 = Strongly Agree.
Degree of Adherence to the treatments
Monitored by tracking attendance at treatment sessions according to the following scale: 1 = No adherence (less than 20%), 2 = Minimal adherence (20% - 39%), 3 = Low adherence (40% - 59%), 4 = Moderate adherence (60% - 79%), 5 = High adherence (80% - 99%), and 6 = Complete adherence (100%).
Sponsors and contacts
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Instituto Médico Tecnológico SL
Lead sponsor
University Ramon Llull
Sponsor institution
RAPbarcelona
Collaborator