Virtual Auricular Acupressure and Baduanjin Qigong Exercise for Preventing Menstrual Pain in Females: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory-Short Form (BPI-SF)
研究概览
简要总结
This research study is testing two self-care approaches that may help prevent or reduce period pain in young females with recurrent painful menstrual cramps. Participants will be placed by chance into 1 of 3 groups: auricular acupressure, Baduanjin qigong, or a self-care education comparison group. The auricular acupressure and Baduanjin groups will receive online training and then practice the treatment on their own for 12 weeks. The main question is whether these two approaches can reduce the severity of menstrual pain. The study will also look at whether they can improve other symptoms that often happen with period pain, such as tiredness, poor sleep, anxiety, low mood, trouble concentrating, and reduced physical function. Researchers will also study stool and blood-related biological markers to better understand whether changes in gut bacteria and body metabolism may be linked to symptom improvement. A total of 145 participants will take part in the study at NTU, and any side effects or other safety concerns will be checked every week.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •16 - 35 years of age
- •Regular menstrual cycles (28 days ± 7 days) in 3 months prior to enrollment
- •Two or more episodes of menstrual cramps in the past 2 months, scored at least 4 points on the worst pain item of the Brief Pain Inventory (BPI)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Ability to download, install, and navigate the study-specific digital content and use its core functions for training, self-guided intervention administration, and data entry
- •Ability to understand the nature of the study and willingness to give informed consent.
排除标准
- •Uncontrolled neurological diseases, immunodeficiency, bleeding disorders, and allergies
- •The presence of another Axis I disorder not in remission
- •Lactating or pregnant, or those planning to become pregnant in the coming half year
- •Undergoing other trials for pain management during the study period
- •Plan to initiate other pain therapies for menstrual pain management in the proceeding 3 months
研究组 & 干预措施
Virtual Auricular Acupressure
A total of 18 sessions of auricular acupressure sessions over 12 weeks, including: (1) Six acupuncturist-led, virtual group training sessions on auricular acupressure; (2) Twelve self-administered, weekly auricular acupressure sessions.
干预措施: Virtual Auricular Acupressure (Behavioral)
Self Education Control
Attention control group with 18 sessions of self education session on menstruation hygiene, including: (1) Six researcher-led, virtual group training sessions on menstrual hygiene; (2) Twelve self-led, weekly menstrual hygiene training sessions.
干预措施: Self Education (Behavioral)
Virtual Baduanjin Qigong Exercise
A total of 18 sessions of Baduanjin Qigong exercise sessions over 12 weeks, including: (1) Six instructor-led, virtual exercise training sessions on Baduanjin Qigong; (2) Twelve self-administered, weekly Baduanjin Qigong exercise sessions.
干预措施: Virtual Baduanjin Qigong Exercise (Behavioral)
结局指标
主要结局
Brief Pain Inventory-Short Form (BPI-SF)
时间窗: 0, 4, 8, 12 Weeks
BPI-SF is an 11-item pain instrument validated to quantify pain severity (4 items) and pain interference (7 items). It is one of the most widely used instruments to measure pain in patients and has been demonstrated to be a reliable, valid, and responsive measure. BPI worst pain item measures pain at its worst on a 0-10 numeric rating scale, where 0 means no pain at all, and 10 indicates the worst pain imaginable.
次要结局
- Brief Fatigue Inventory (BFI)(0, 4, 8, 12 Weeks)
- Pain Catastrophizing Scale (PCS)(0, 4, 8, 12 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(0, 4, 8, 12 Weeks)
- Hospital Anxiety and Depression Scale (HADS)(0, 4, 8, 12 weeks)
- Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-Global)(0, 4, 8, 12 Weeks)
- Stroop Color and Word Test (SCWT)(0, 4, 8, 12 Weeks)
- Patient-Reported Outcomes Measurement Information System-Self-Reported Measure of Physical Function (PROMIS-Physical Function)(0, 4, 8, 12 Weeks)
- Pain Medication Use(0, 4, 8, 12 Weeks)
- Pain Diary(0, 4, 8, 12 Weeks)
研究者
Yang Mingxiao
Assistant Professor, Director of iHealth Lab
Nanyang Technological University