Primary DysmenorrheaNCT07726264
Effect of a Magnesium Sulfate Footbath on Primary Dysmenorrhea Pain
A study testing Magnesium Sulfate Warm-Water Footbath and Warm-Water Footbath in people with Primary Dysmenorrhea, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Magnesium Sulfate Warm-Water Footbath and Warm-Water Footbath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 22 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Magnesium Sulfate Warm-Water Footbath, Warm-Water Footbath
- Keywords
- Menstrual pain, Magnesium sulfate, Footbath, Young women
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate Warm-Water FootbathOther
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 FootbathOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
Sensory Pain Rating Index Score
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.
Measured: Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
Affective Pain Rating Index Score
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.
Measured: Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
Total Pain Rating Index Score
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.
Measured: Immediately after the 20-minute intervention, 1 hour after the intervention, and 2 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Sep 2025
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Sena Dilek Aksoy, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726264
- Sponsor's protocol ID
- SDilek14
- Other IDs
- 1919B012414230
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because data sharing was not included in the participant consent process.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Warm-Water Footbath Containing Magnesium Sulfate on Pain in Women With Primary Dysmenorrhea: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07726264
- Acronym / sponsor ID
- SDilek14
- Conditions
- Primary Dysmenorrhea
- Keywords
- Menstrual pain, Magnesium sulfate, Footbath, Young women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate Warm-Water Footbath | Experimental | Other: Magnesium Sulfate Warm-Water FootbathParticipants 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. |
| Warm-Water Footbath | Active comparator | Other: Warm-Water FootbathParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate Warm-Water FootbathA 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. | Other | Magnesium Sulfate Warm-Water Footbath |
| Warm-Water FootbathA 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. | Other | Warm-Water Footbath |
Primary outcome
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.
4 secondary outcomes
Present Pain Intensity Score
Time frame: 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
Affective Pain Rating Index Score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because data sharing was not included in the participant consent process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate Warm-Water Footbath and Warm-Water Footbath in people with Primary Dysmenorrhea, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.