Effect of Massage and Hydrotherapy to Improve Well-being and Pain Perception in Women With Endometriosis Unresponsive to Conventional Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Changes in Pain intensity assessed by NRS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in Pain intensity assessed by NRS
时间窗: Baseline and immediately after intervention
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
次要结局
- 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 functioning assessed by PROMIS-29(Baseline and immediately after intervention)
- Changes in Subjective well-being assessed by EBS-20(Baseline and immediately after intervention)
- Changes in quality of life assessed by EHP-30(Baseline and immediately after intervention)
研究者
Francisco Artacho Cordón
Proffesor
Universidad de Granada
