Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain | NCT07726264

NCT07726264

Overview

NCT ID: NCT07726264
Lead Sponsor: Kocaeli UniversityOTHER
Official Title: Effect of a Warm-Water Footbath Containing Magnesium Sulfate on Pain in Women With Primary Dysmenorrhea: A Three-Arm Randomized Controlled Trial
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

Status and Timeline

Status: Completed
Last Update Posted: Jul 24, 2026Actual
Start Date: Sep 1, 2025Actual
Primary Completion Date: May 22, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Kocaeli University

Similar Studies

Participant Group/Arms

Magnesium Sulfate Warm-Water FootbathExperimental

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 FootbathActive 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 ControlNo 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.