Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain
21 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Kocaeli, Turquie (Türkiye), 41380
- Kocaeli University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Visual Analogue Scale Pain Score
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Present Pain Intensity Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2025
Achèvement primaire (Réel)
22 mai 2026
Achèvement de l'étude (Réel)
22 mai 2026
Dates d'inscription aux études
Première soumission
21 juillet 2026
Première soumission répondant aux critères de contrôle qualité
21 juillet 2026
Première publication (Réel)
24 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SDilek14
- 1919B012414230 (Autre subvention/numéro de financement: TUBITAK)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be made publicly available because data sharing was not included in the participant consent process.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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