Primary Dysmenorrhea
Conditions
Keywords
Menstrual pain, Magnesium sulfate, Footbath, Young women
Brief summary
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.
Detailed description
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.
Interventions
OTHERMagnesium Sulfate Warm-Water Footbath
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.
OTHERWarm-Water Footbath
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.
Sponsors
Kocaeli University
The Scientific and Technological Research Council of Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants were randomly assigned in a 1:1:1 ratio to a magnesium sulfate warm-water footbath group, a warm-water footbath group, or a no-intervention control group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale Pain Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Present Pain Intensity Score | 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. |
| Sensory Pain Rating Index Score | 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. |
| Affective Pain Rating Index Score | 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. |
| Total Pain Rating Index Score | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed