Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506708
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Effect of Massage and Hydrotherapy to Improve Well-being and Pain Perception in Endometriosis Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Massage and Hydrotherapy to Improve Well-being and Pain Perception in Women With Endometriosis Unresponsive to Conventional Treatment
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 v240 software
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 v240 software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None