跳至主要内容
临床试验/NCT07241637
NCT07241637已完成不适用

The Effect of Tele-Yoga Application on Chronic Pelvic Pain, Fatigue and Quality Of Life In Women With Endometriosis Diagnosis

Ankara University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Numerical Rating Scale (NRS)

研究概览

简要总结

This study aims to examine the effects of Tele-yoga on chronic pelvic pain, fatigue, and quality of life in patients diagnosed with endometriosis. It will be conducted as a single-center, randomized controlled experimental study design.

详细描述

Endometriosis is a chronic, estrogen-dependent condition affecting approximately 10% of women of reproductive age worldwide. In Türkiye, it is estimated that around 2.4 million women are diagnosed with endometriosis. The disease is commonly associated with symptoms such as chronic pelvic pain (CPP), dysmenorrhea, dyspareunia, and infertility, among which CPP is the most prevalent. Endometriosis-related pain is typically recurrent and progressive, significantly impairing women's daily activities and overall quality of life.

Fatigue is another frequently reported symptom among women with endometriosis. Evidence indicates that fatigue is substantially more common in this population compared to the general female population and has a detrimental impact on both physical and psychological well-being. The coexistence of chronic pain and fatigue further exacerbates the negative effects of endometriosis on quality of life.

In recent years, there has been growing interest in Complementary and Integrative Health Approaches (CIHA) for managing pain and fatigue associated with endometriosis. The National Institute for Health and Care Excellence (NICE) guidelines emphasize the importance of multidisciplinary and mind-body-based strategies in endometriosis management. Yoga, recognized by the World Health Organization (WHO) as a complementary health practice, integrates physical postures, breathing exercises, and meditation. It is a low-cost, non-invasive intervention known to promote relaxation and reduce pain, stress, and fatigue.

Telerehabilitation enables the remote delivery of such interventions through digital technologies, improving accessibility and continuity of care. However, there is a limited number of studies investigating telerehabilitation-based yoga interventions among women experiencing chronic pelvic pain due to endometriosis.

Therefore, this project aims to examine the effects of Tele-yoga on chronic pelvic pain, fatigue, and quality of life in women diagnosed with endometriosis. The findings of this research are expected to contribute to developing holistic, accessible, and evidence-based management strategies for women living with endometriosis

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Voluntary willingness to participate in the study.
  • •Ability to communicate effectively, with no language barriers.
  • •Completion of at least primary school education.
  • •Aged 18 years or older.
  • •Premenopausal.
  • •Mild (1-3) or moderate (4-6) chronic pelvic pain.
  • •Not pregnant.
  • •No use of any complementary and integrative health practice during the study period.
  • •No regular exercise (defined as exercising more than three times per week).
  • •No physiotherapy within the previous 3 months.
  • •No pelvic surgery within the previous year.
  • •No planned surgical treatment for endometriosis.
  • •No other injury or medical condition causing pelvic pain.
  • •Access to a computer, smartphone, or tablet with a camera and a stable internet connection to participate in the online sessions.

排除标准

  • •Participant's request to withdraw from the study at any stage.
  • •Failure to attend all tele-yoga sessions.
  • •Initiation of regular exercise or physiotherapy during the study period.
  • •Pregnancy during the study period.
  • •Decision to undergo surgical treatment during the study period.

研究组 & 干预措施

Tele-Yoga Group

Experimental

The researcher conducted live online tele-yoga sessions with participants diagnosed with endometriosis who had chronic pelvic pain using a computer or tablet. The intervention consisted of 16 individual sessions delivered twice weekly over eight weeks, with each session lasting 60 minutes. Sessions were conducted via Google Meet between the researcher and each participant. The schedule for the following week's sessions was determined after the second session each week. All sessions were conducted in a private setting chosen by the participant to ensure privacy and comfort, and no screenshots or video recordings were taken. Each session began with breathing exercises and a 10-minute meditation in the Sukhasana pose, followed by a 10-minute warm-up of stretching and mobilization exercises. This was followed by a 35-minute yoga sequence integrating various asanas with breathing techniques and concluded with 5 minutes of deep relaxation in the Savasana pose.

干预措施: Tele-Yoga Group (Behavioral)

Control Group

No Intervention

No intervention was applied to the control group. Participants were followed for eight weeks and completed the study scales at the end of the eighth week.

结局指标

主要结局

Numerical Rating Scale (NRS)

时间窗: The scale was administered to all groups before the intervention began and after the intervention was completed (at the end of the eighth week).

In patients diagnosed with endometriosis, the Numerical Rating Scale (NRS) is used to assess pain intensity by having the patient rate their perceived pain on a scale from 0 to 10.A value of 0 is considered "no pain," while a value of 10 is considered "the worst pain imaginable." Patients are asked to circle the number representing the amount of pain they experience during the assessment. As the number on the scale increases, the pain increases.

次要结局

  • The Fatigue Severity Scale (FSS)(The scale was administered to all groups before the intervention and after the intervention was completed (at the end of the eighth week).)
  • The Endometriosis Health Profile-5 (EHP-5)(The scale was administered to all groups before the intervention began and after the intervention was completed (at the end of the eighth week).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melek Hava Köprülü

PhD Student

Ankara University

研究点 (2)

Loading locations...

相似试验