Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain
21 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
120
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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-
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Kocaeli, Turquia (Türkiye), 41380
- Kocaeli University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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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|
Comparador Ativo: 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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Visual Analogue Scale Pain Score
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Present Pain Intensity Score
Prazo: 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.
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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
Prazo: 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
Prazo: 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
Prazo: 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.
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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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2025
Conclusão Primária (Real)
22 de maio de 2026
Conclusão do estudo (Real)
22 de maio de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2026
Primeira postagem (Real)
24 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SDilek14
- 1919B012414230 (Número de outro subsídio/financiamento: TUBITAK)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be made publicly available because data sharing was not included in the participant consent process.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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