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

NCT ID: NCT06506708

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-07-31

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.

Detailed Description

The main objective of this project 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 (CPP).

For this purpose, a two-arm pre-post intervention study will be conducted, randomizing 44 women with CPP (22 in the intervention group and 22 in the control group). The intervention group, in addition to following the treatment proposed by their gynecologist, will participate in a comprehensive HAMMAM experience consisting of 3 sessions (one session each 14 days), where they will undergo a 75-minute thermal circuit (cold, warm and hot water pools) and a 15-minute of Swedish massage with a special focus in the abdomino-lumbo-pelvic region. During the last session, massage will be precceded by a 15-min traditional Kessa massage. During kessa massage, women will lie on a hot stone table for 15 minutes, while the skin is covered with red grape soap suds and scrubbed with a cotton fiber glove (kessa). The scrubbing will cleanse the skin of any dirt and residues, which may help them achieve a fully relaxed feeling

As participants in the intervention group, those in the the control group will receive the treatment stipulated by their gynecologist.

Participants will be evaluated before the start of the intervention (t0), and at the end of the last session (t1) on both self-reported variables (subjective well-being scale, satisfaction with life scale, quality of life, pain intensity, pain interference and pain catastrophizing scale), and objective variables (pressure pain thresholds).

Treatment efficacy will be analyzed using ANCOVA through SPSS v24.0 software.

Conditions

Endometriosis; Chronic Pelvic Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

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.

Group Type: EXPERIMENTAL

Hydrotherapy + massage

Intervention Type: 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.

Interventions

Hydrotherapy + massage

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Francisco Artacho Cordón

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Artacho-Cordón

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Francisco Artacho Cordón

Granada, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Francisco Artacho-Cordón

Role: CONTACT

fartacho@ugr.es

958249983

Olga Ocón-Hernández

Role: CONTACT

ooconh@ugr.es

0034-958-242-865

Facility Contacts

Francisco Artacho-Cordón, Dr

Role: primary

fartacho@ugr.es

958249983

Other Identifiers

HAMMAM

Identifier Type: -

Identifier Source: org_study_id