Acute Impact of Virtual Reality-Based Relaxation and Exergaming Compared to Traditional Relaxation on Primary Dysmenorrhea Symptoms: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Abdomino-Pelvic Pain İntensity (APPI)
研究概览
简要总结
The goal of this clinical trial is to investigate the acute effects of virtual reality-based relaxation (immersive VR relaxation) and exergaming (non-immersive VR) compared to traditional Jacobson's relaxation on symptoms of primary dysmenorrhea (PD) in women aged 18-30 years with regular menstrual cycles. The main questions it aims to answer are:
Does immersive VR relaxation reduce abdomino-pelvic pain and menstrual symptom severity more effectively than Jacobson's relaxation? Does non-immersive VR exergaming provide better pain relief and symptom management compared to traditional relaxation methods?
Hypotheses:
Immersive VR relaxation will result in significantly greater reductions in abdomino-pelvic pain and menstrual symptom severity compared to traditional relaxation.
Non-immersive VR exergaming will also provide better outcomes in pain and symptom management compared to traditional relaxation.
Researchers will compare immersive VR relaxation, non-immersive VR exergaming, and Jacobson's relaxation (control group) to determine the relative effectiveness of each intervention.
Participants will:
Engage in a 20-minute session of one of the assigned interventions. Complete questionnaires on abdomino-pelvic pain, menstrual symptoms, and perceived effectiveness.
Participate in follow-up assessments for sleep quality during menstruation. This study aims to explore innovative, technology-driven approaches for managing menstrual symptoms and their effectiveness relative to traditional methods.
详细描述
This study seeks to address this gap by investigating whether these innovative approaches can provide superior symptom relief. By evaluating pain intensity, symptom severity, and perceived effectiveness, this research will provide valuable insights into the feasibility and advantages of integrating technology into dysmenorrhea management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-30 with no pregnancy history.
- •a regular menstrual cycle (28 ± 7 days) over the past 6 months
- •menstrual pain with a Visual Analog Scale score >4 during this period
排除标准
- •regular medication use or medical treatment during the study (e.g., oral contraceptives, antidepressants).
- •recent musculoskeletal trauma or surgery.
- •intrauterine device use or pathological conditions/ultrasound findings of secondary dysmenorrhea
- •consumption of painkillers, alcohol, recreational drugs, or similar substances within the last 48 hours.
研究组 & 干预措施
Immersive Virtual Reality Based Relaxation
干预措施: Immersive Virtual Reality-Based Relaxation (Behavioral)
Non-Immersive Virtual Reality Based Exergaming
干预措施: Non-immersive VR-Based Exergaming (Behavioral)
Traditional Jacobson's Relaxation
干预措施: Jacobson's Relaxation (Behavioral)
结局指标
主要结局
Abdomino-Pelvic Pain İntensity (APPI)
时间窗: Immediately before and immediately after the 20-minute intervention session
Visuel Analogue Scale was used to measure abdomino-pelvic pain intensity. A 10 cm line was labeled with "0 cm" indicating no pain and "10 cm" representing unbearable pain at each end. Participants were asked to indicate their pain level by either drawing a line, placing a dot, or marking a point along the scale. Pain assessments were made for the most painful menstrual day and abdomino-pelvic pain on the intervention day.
Menstruation-Related Symptoms
时间窗: Immediately before and immediately after the 20-minute intervention session
The Daily Symptom Rating Scale (DSRS), a 17-item self-report tool, was used to assess the intensity of various menstrual symptoms, including pain, mood swings, and physical discomfort. Each symptom was rated on a scale from 0 (no symptoms) to 5 (severe), with higher scores indicating greater symptom severity. The Turkish version of the scale has been validated and shown to be reliable .
次要结局
- Sleep Quality(The morning following the intervention and the morning of the most painful day during the subsequent menstrual cycle.)
研究者
Muhammed Şeref Yıldırım
Principle Investigator
Trakya University