Effect of Massage and Hydrotherapy to Improve Well-being and Pain Perception in Endometriosis Patients
NCT Number: NCT06506708
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis|Chronic Pelvic Pain Syndrome
Interventions: OTHER: Hydrotherapy + massage
Sponsor: Universidad de Granada
Sex: FEMALE
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-07-31
Locations: Francisco Artacho Cordón, Granada, 18016, Spain

Summary:
The objective is to analyze the short-term effect of a comprehensive HAMMAM experience combining therapeutic hydrotherapy, aromatherapy, music therapy, and Swedish massage on objective parameters and patient-reported outcomes related to well-being generation and pain reduction in women with endometriosis-related chronic pelvic pain.

Primary Outcome Measures: Changes in Pain intensity assessed by NRS, Numeric Rating Scale (NRS) will be used to identify self-reported levels of chronic pelvic pain, dysmenorrhea, dyspareunia, dyschezia and dysuria.. Scores range from 0 to 10. Higher scores represent increased pain intensity, Baseline and immediately after intervention
Secondary Outcome Measures: Changes in Pain Interference assessed by BPI, Brief Pain Inventory (BPI) will be used to address the interference of pain with daily life activities, scored in a 11-point Likert-type scale, where higher scores indicate higher pain interference., Baseline and immediately after intervention|Changes in Pressure pain threshold (PPT) assessed by algometry, Algometry will be used to measure PPT levels in abdomen, pelvis and lower back regions through an electronic algometer. For this purpose, an approximate rate of 0.3 kilograms/s will be applied with a 1cm2 probe. Seven points from the abdominal and pelvic area, and two additional points from the lower back region will be tested. Prior PPT assessment, assessor will ask for participants to press the switch when they first feel a change from pressure to pain. The mean of three tests, spaced by 30 s, will be used for the analysis., Baseline and immediately after intervention|Changes in Catastrophizing thoughts assessed by PCS, The Pain Catastrophizing Scale (PCS) will be also used to assess catastrophic thinking related to pain. Scores of this 13-item scale range from 0 to 52. Higher scores represent higher catastrophic thoughts., Baseline and immediately after intervention|Changes in quality of life assessed by EHP-30, It will be assessed using the Endometriosis Health Profile-30 (EHP-30). It is a self-administered disease-specific instrument to measure QoL in women with endometriosis. The 30-item EHP, referred to the last 4 weeks, is comprised of five domains: pain, control and powerlessness, emotional well-being, social support, and self-image. Items within each subscale, answered on a 5-point Likert-type scale, are summed and then transformed to a percentage scale ranging from 0 (best health status) to 100 (worse health status) by dividing the raw score of all items by the maximum possible raw score, multiplied by 100, Baseline and immediately after intervention|Changes in functioning assessed by PROMIS-29, The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) will be used. The PROMIS-29 is a 29-item instrument designed to measure functioning in a wide variety of clinical situations. It is divided in subscales (Physical Function; Anxiety; Depression; Fatigue; Sleep Disturbance; Ability to Participate in Social Roles and Activities; Pain Interference and Pain Intensity). Each item is scored from 1 to 5; a higher score indicates a higher degree of the construct being measured. For the subscales Physical Function and Ability to Participate in Social Roles and Activities, a higher score indicates better functioning, whereas for the other subscales a higher score indicates worse functioning., Baseline and immediately after intervention|Changes in Subjective well-being assessed by EBS-20, The subjective Well-being Scale (EBS-20) will be used. This scale is comprised by 20 items, scored in a 6-point Likert-type scale. The mean score is calculated, with higher scores representing higher well-being., Baseline and immediately after intervention