Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain

July 21, 2026 updated by: 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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Active Comparator: 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale Pain Score
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Present Pain Intensity Score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

May 22, 2026

Study Completion (Actual)

May 22, 2026

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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