Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain

NCT07726264 | Completed

• 2 other identifiers: SDilek141919B012414230
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Keywords

Menstrual pain; Magnesium sulfate; Footbath; Young women

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analogue Scale Pain Score

  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 Outcomes (4)

• Present Pain Intensity Score

  Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention

• Sensory Pain Rating Index Score

  Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention

• Affective Pain Rating Index Score

  Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention

• Total Pain Rating Index Score

  Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention

Study Arms (3)

Magnesium Sulfate Warm-Water Footbath

EXPERIMENTAL

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.

Other: Magnesium Sulfate Warm-Water Footbath

Warm-Water Footbath

ACTIVE COMPARATOR

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.

Other: Warm-Water Footbath

No-Intervention Control

NO INTERVENTION

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.

Interventions

Magnesium Sulfate Warm-Water Footbath OTHER

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.

Magnesium Sulfate Warm-Water Footbath

Warm-Water Footbath OTHER

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.

Warm-Water Footbath

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators supervising the interventions were aware of group allocation due to the nature of the interventions. The outcomes assessor was blinded to group allocation. Study groups were coded during outcome assessment and data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: Participants were randomly assigned in a 1:1:1 ratio to a magnesium sulfate warm-water footbath group, a warm-water footbath group, or a no-intervention control group.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: September 1, 2025
• Primary Completion: May 22, 2026
• Study Completion: May 22, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)