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Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain

21. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Annen: 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 inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kocaeli University

Samarbeidspartnere

The Scientific and Technological Research Council of Turkey

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2025

Primær fullføring (Faktiske)

22. mai 2026

Studiet fullført (Faktiske)

22. mai 2026

Datoer for studieregistrering

Først innsendt

21. juli 2026

Først innsendt som oppfylte QC-kriteriene

21. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SDilek14
  • 1919B012414230 (Annet stipend/finansieringsnummer: TUBITAK)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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