Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain
Effect of a Warm-Water Footbath Containing Magnesium Sulfate on Pain in Women With Primary Dysmenorrhea: A Three-Arm Randomized Controlled Trial
研究概览
详细说明
Primary dysmenorrhea is menstrual pain that occurs without an identifiable pelvic disorder. It is common among young women and may negatively affect daily activities and quality of life. Nonpharmacological interventions that are simple, inexpensive, and suitable for home use may support pain management.
This study was designed as a three-arm, parallel-group randomized controlled trial. A total of 120 women with primary dysmenorrhea were randomly assigned in a 1:1:1 ratio to one of three groups. Participants in the magnesium sulfate group immersed their feet in 10 liters of warm water containing 200 g of magnesium sulfate. Participants in the warm-water group received the same footbath without magnesium sulfate. Participants in the control group received no intervention. The footbath was applied for 20 minutes. The water temperature was maintained between 34°C and 37°C. The feet were immersed to approximately 10-15 cm above the ankles. The intervention was performed at the participants' homes and supervised by researchers through a video call.Pain was assessed using the Visual Analogue Scale and the Short-Form McGill Pain Questionnaire. The Visual Analogue Scale was measured at baseline, 20 minutes, 1 hour, and 2 hours. Present Pain Intensity and the sensory, affective, and total Pain Rating Index scores were assessed at 20 minutes, 1 hour, and 2 hours. Participants were asked not to use analgesics, heat therapy, or another pain-relief method during the two-hour follow-up period.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Kocaeli、土耳其（türkiye）、41380
- Kocaeli University
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Women aged 18-35 years
- Having regular menstrual cycles
- Experiencing primary dysmenorrhea
- Having a menstrual pain score of at least 3 on the Visual Analogue Scale
- Engaging in physical activity no more than twice per week
- Having a body mass index of 29.9 kg/m² or lower
- Willing to participate and providing informed consent
Exclusion Criteria:
- Previous childbirth
- Presence of varicose veins, open wounds, or skin lesions on the feet or lower legs
- Presence of an acute or chronic foot condition
- Medical advice against warm-water footbath use
- Use of hormonal contraceptives
- Frequent use of anti-inflammatory or analgesic medications
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Magnesium Sulfate Warm-Water Footbath
Participants immersed their feet in 10 L of warm water containing 200 g of magnesium sulfate for 20 minutes.
The water temperature was maintained between 34°C and 37°C.
The feet were immersed to approximately 10-15 cm above the ankles.
The intervention was performed at home and supervised by the researchers through a video call.
|
A 20-minute footbath using 10 L of warm water containing 200 g of magnesium sulfate.
The water temperature was maintained between 34°C and 37°C, and the feet were immersed to approximately 10-15 cm above the ankles.
The intervention was administered during the first three days of menstruation when the participant's pain score was at least 3.
|
|
有源比较器：Warm-Water Footbath
Participants immersed their feet in 10 L of warm water without magnesium sulfate for 20 minutes.
The water temperature was maintained between 34°C and 37°C.
The feet were immersed to approximately 10-15 cm above the ankles.
The intervention was performed at home and supervised by the researchers through a video call.
|
A 20-minute footbath using 10 L of warm water without magnesium sulfate.
The water temperature was maintained between 34°C and 37°C, and the feet were immersed to approximately 10-15 cm above the ankles.
The intervention was administered during the first three days of menstruation when the participant's pain score was at least 3.
|
|
无干预：No-Intervention Control
Participants received no footbath or other study intervention during the two-hour follow-up period.
They were instructed not to use analgesics, heat therapy, or other nonpharmacological pain-relief methods during this period.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Visual Analogue Scale Pain Score
大体时间：Baseline, immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
Menstrual pain intensity was assessed using a 10-cm Visual Analogue Scale ranging from 0 to 10, where 0 indicated no pain and 10 indicated the worst imaginable pain.
Higher scores indicated greater pain intensity.
|
Baseline, immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Present Pain Intensity Score
大体时间：Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
Present pain intensity was assessed using the Present Pain Intensity component of the Short-Form McGill Pain Questionnaire.
Scores range from 0 to 5, with higher scores indicating greater pain intensity.
|
Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
|
Sensory Pain Rating Index Score
大体时间：Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
The sensory dimension of pain was assessed using the 11 sensory descriptors of the Short-Form McGill Pain Questionnaire.
Each descriptor is rated from 0 to 3. Total sensory scores range from 0 to 33, with higher scores indicating greater sensory pain.
|
Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
|
Affective Pain Rating Index Score
大体时间：Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
The affective dimension of pain was assessed using the four affective descriptors of the Short-Form McGill Pain Questionnaire.
Each descriptor is rated from 0 to 3. Total affective scores range from 0 to 12, with higher scores indicating greater affective pain.
|
Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
|
Total Pain Rating Index Score
大体时间：Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
The total Pain Rating Index was calculated by summing the sensory and affective descriptor scores of the Short-Form McGill Pain Questionnaire.
Scores range from 0 to 45, with higher scores indicating greater pain.
|
Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SDilek14
- 1919B012414230 (其他赠款/资助编号：TUBITAK)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.