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Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain

21. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Magnesium 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.
Aktiv komparator: 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.
Andet: Warm-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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Visual Analogue Scale Pain Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Present Pain Intensity Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kocaeli University

Samarbejdspartnere

The Scientific and Technological Research Council of Turkey

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2025

Primær færdiggørelse (Faktiske)

22. maj 2026

Studieafslutning (Faktiske)

22. maj 2026

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SDilek14
  • 1919B012414230 (Andet bevillings-/finansieringsnummer: TUBITAK)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be made publicly available because data sharing was not included in the participant consent process.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Primær dysmenoré

Kliniske forsøg med Magnesium Sulfate Warm-Water Footbath

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