Effect of Massage and Hydrotherapy to Improve Well-being and Pain Perception in Endometriosis Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversidad de Granada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pelvic pain during the last 6 months more or equal to 4 in a NRS scale.
Diagnosed with endometriosis (through surgery, magnetic resonance imaging or ultrasound imaging)
Premenopausal status
Be able to walk without assistance and to read and write enough
Disqualifiers
Acute or terminal illness
A recent fracture in any upper or lower extremity (<3 months), disc herniation and any chronic disease or orthopaedic issues that would interfere with her ability to participate in this intervention program
Express unwillingness to complete the study requirements
Be involved in other rehabilitation program
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrotherapy + massage
Other interventionThe comprehensive Hammam experience will consist of 3 sessions at the Arab baths of Hammam Al Ándalus, Granada -Spain- (once every two weeks). Each session will involve a thermal circuit lasting approximately 75 minutes, following the institution's guidelines, inviting women to explore the warm, hot, and cold water baths, as well as the steam room. The thermal circuit will be complemented by a 15-minute relaxing massage using essential oils. During the final session, massage will be preceeded by a traditional Kessa treatment on a hot stone bed. During sessions, women will be involved in a multisensory experience, including aromatherapy and where they will also have the opportunity to sipping on mint tea and relax on a building all decorated in resplendent Arabian décor. One member of the research team will be responsible for coordinating the sessions in collaboration with the Al Ándalus institution, subject to their availability.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Usual care groupNo intervention 0 interventions
Group B: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and immediately after interventionSecondary outcomes
1
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.
Time frame
Baseline and immediately after intervention2
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.
Time frame
Baseline and immediately after intervention3
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.
Time frame
Baseline and immediately after intervention4
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
Time frame
Baseline and immediately after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov