Effect of a Therapeutic Exercise and an Education Program on Sexual Function and Experience in People With Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Valencia
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Quality of Life - Sexual Function
Study Overview
Brief Summary
This is a randomized clinical trial that will be carried out in people with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic exercise combine with sexual education, and the control group (CG) who will receive the therapeutic exercise program.
The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after 4 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). Objective and subjective data of the participants will be evaluated. T1 will be assessed with a sociodemographic questionnaire and the FSFI and MSSCQ surveys. T2 and T3 will assess blood pressure, heart rate, variability of the autonomic system, the ability to dissociate the lumbopelvic movement from the thoracolumbar, measurement of the muscles of the transverse, internal and external obliques, the distance between the rectus abdominis and the pelvic floor, subjective perception of effort during exercise and subjective perception of orgasmic intensity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •People of legal age (over 18 years old)
- •Not older than 50 years old
- •Currently residing in Spain
- •Spanish speakers
- •With a medical diagnosis of endometriosis
- •Without any other associated gynecological pathology
Exclusion Criteria
- •People over 50 years old
- •Those with cognitive limitations that prevent them from completing the different questionnaires used
- •People who are involved in litigation processes
- •People with gynecological pathologies other than endometriosis
Arms & Interventions
Therapeutic Exercise
They will recive the therapeutic exercise program.
Intervention: Therapeutic Exercise (Procedure)
Therapeutic exercise and sexual education
They will receive ta combined program, which will combine therapeutic exercise with a sexual education classes.
Intervention: Therapeutic exercise and sexual education (Combination Product)
Outcomes
Primary Outcomes
Quality of Life - Sexual Function
Time Frame: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
The Index of Female Sexual Function (IFSF) will be used. It is a multidimensional self-reported instrument for the evaluation of female sexual function. The scores for the same domain are added together and multiplied by the factor that corresponds to each domain. The total score is obtained by adding the scores for the 6 domains. A score of 0 in any of the domains indicates a lack of sexual activity in the last month.The maximum total score will be 36 points and the minimum 2. The higher the score, the better the sexual function.
Quality of Life - Sexual self-concept
Time Frame: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Multidimensional Scale of Sexual Concept (MSSCQ) will be used. It is a multidimensional self-reported instrument for the evaluation of sexual self- concept. Each answer has a score of 0 to 4 points. The higher the score, the better the sexual assertiveness and sexual self-concept. There are a total of 16 questions. The maximum score is 64 points and the minimum is 0.
Secondary Outcomes
- Quality of Life - Pleasure(Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).)
- Physical-Funcionality - Motor control(Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).)
- Physical-Funcionality- Pelvic floor and abdominal ultrasound(Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).)
Investigators
Laura Fuentes Aparicio
Assistant Professor of Physiotherapy
University of Valencia