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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorInstituto Médico Tecnológico SL

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pelvify: Menopause and dyspareunia treatment

    Behavioral

    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.

  • Face to Face Physical Therapy Protocol

    Other intervention

    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.

  • Face to Face Protocol Combined With an Asynchronous Telerehabilitation Program

    Other intervention

    Both, the face to face protocol and the Asynchronous Telerehabilitation Program will be carried on on this group.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Asynchronous Online Telerehabilitation ProgramExperimental treatment 1 intervention
Group B: Face to Face Physical Therapy ProtocolActive comparator 1 intervention
Group C: Face to Face Protocol Combined With an Asynchronous Telerehabilitation ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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
2

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.

Time frame
From enrollment to the end of treatment at 5 weeks, one week after treatment, and at six months and twelve months post treatment
3

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.

Time frame
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

Secondary outcomes

1

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.

Time frame
From enrollment to one week after treatment

Other outcomes

1

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

Time frame
During the five weeks of treatment and one week after finishing it.
2

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.

Time frame
One week after the end of treatment, and 6 months and 12 months after treatment
3

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%).

Time frame
During the five weeks of treatment, 1 week after treatment, and at 6 months and 12 months after treatment

Sponsors and contacts

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Instituto Médico Tecnológico SL

Lead sponsor

University Ramon Llull

Sponsor institution

RAPbarcelona

Collaborator