Effect of Massage and Hydrotherapy to Improve Well-being and Pain Perception in Endometriosis Patients

NCT06506708 | Recruiting

• 1 other identifier: HAMMAM
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis; Chronic Pelvic Pain Syndrome

Outcome Measures

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

  Baseline and immediately after intervention

Secondary Outcomes (6)

• Changes in Pain Interference assessed by BPI

  Baseline and immediately after intervention

• Changes in Pressure pain threshold (PPT) assessed by algometry

  Baseline and immediately after intervention

• Changes in Catastrophizing thoughts assessed by PCS

  Baseline and immediately after intervention

• Changes in quality of life assessed by EHP-30

  Baseline and immediately after intervention

• Changes in functioning assessed by PROMIS-29

  Baseline and immediately after intervention

Study Arms (2)

Usual care group

NO INTERVENTION

The gynecologist will proceed to administer the standard treatments to the control group. Moreover, assessors will emphasize healthy lifestyle benefits.

Experimental group

EXPERIMENTAL

The comprehensive Hammam experience will consist of 3 sessions at the Arab baths of Hammam Al Ándalus, Granada -Spain- (once session each 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 Swedish 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 relaxing music, 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.

Other: Hydrotherapy + massage

Interventions

Hydrotherapy + massage OTHER

The 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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Be capable and willing to provide consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Francisco Artacho Cordón

Granada, 18016, Spain

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Hydrotherapy; Massage

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies

Study Officials

• Francisco Artacho-Cordón

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco Artacho-Cordón

CONTACT

958249983; fartacho@ugr.es

Olga Ocón-Hernández

CONTACT

0034-958-242-865; ooconh@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 17, 2024
• Study Start: May 1, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 31, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)