Effect of a Warm-Water Footbath Containing Magnesium Sulfate on Pain in Women With Primary Dysmenorrhea: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale Pain Score
研究概览
简要总结
Primary dysmenorrhea is a common condition characterized by painful menstruation. This three-arm randomized controlled trial evaluated the effect of a warm-water footbath containing magnesium sulfate on primary dysmenorrhea pain. A total of 120 women were randomized to a magnesium sulfate warm-water footbath group, a warm-water footbath group, or a no-intervention control group. Pain was assessed using the Short-Form McGill Pain Questionnaire and a Visual Analogue Scale at baseline, 20 minutes, 1 hour, and 2 hours after the intervention.
详细描述
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)
盲法说明
Participants and investigators supervising the interventions were aware of group allocation due to the nature of the interventions. The outcomes assessor was blinded to group allocation. Study groups were coded during outcome assessment and data analysis.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Visual Analogue Scale Pain Score
时间窗: 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.
次要结局
- Present Pain Intensity Score(Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention)
- Sensory Pain Rating Index Score(Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention)
- Affective Pain Rating Index Score(Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention)
- Total Pain Rating Index Score(Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention)
研究者
Sena Dilek Aksoy
Assoc. Prof. Dr.
Kocaeli University