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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kocaeli, 터키 (Türkiye), 41380
- Kocaeli University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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활성 비교기: 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.
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Visual Analogue Scale Pain Score
기간: Baseline, immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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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.
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Baseline, immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Present Pain Intensity Score
기간: Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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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.
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Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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Sensory Pain Rating Index Score
기간: Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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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.
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Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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Affective Pain Rating Index Score
기간: Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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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.
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Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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Total Pain Rating Index Score
기간: Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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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.
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Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SDilek14
- 1919B012414230 (기타 보조금/기금 번호: TUBITAK)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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