Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain
21. července 2026 aktualizováno: Sena Dilek Aksoy, Kocaeli University
Effect of a Warm-Water Footbath Containing Magnesium Sulfate on Pain in Women With Primary Dysmenorrhea: A Three-Arm Randomized Controlled Trial
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
120
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kocaeli, Turecko (Türkiye), 41380
- Kocaeli University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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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Aktivní komparátor: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Visual Analogue Scale Pain Score
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Present Pain Intensity Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. září 2025
Primární dokončení (Aktuální)
22. května 2026
Dokončení studie (Aktuální)
22. května 2026
Termíny zápisu do studia
První předloženo
21. července 2026
První předloženo, které splnilo kritéria kontroly kvality
21. července 2026
První zveřejněno (Aktuální)
24. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SDilek14
- 1919B012414230 (Jiné číslo grantu/financování: TUBITAK)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Individual participant data will not be made publicly available because data sharing was not included in the participant consent process.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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