Skip to main content
OpenTrials
Completed

NCT Number: NCT07726264

Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Effect of a Warm-Water Footbath Containing Magnesium Sulfate on Pain in Women With Primary Dysmenorrhea: A Three-Arm Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.