Premenstrual SyndromeNCT07461051
Effects of Foot Bath Therapy on Premenstrual Syndrome Symptoms, Quality of Life, and Pain
A study testing Foot bath therapy in people with Premenstrual Syndrome, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted as a randomized controlled trial to evaluate the effects of foot bath application on symptom severity, quality of life, and pain levels in women with premenstrual syndrome. The research was carried out with 92 midwifery students. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Foot bath therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 1 Jun 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 and 25 years of age
- Having no chronic disease
- Having a symptom severity score of 5 or higher according to the VAS,
- Voluntarily agreeing to participate in the study.
Who cannot join
- Psychiatric disorder
- Secondary dysmenorrhea.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Footbath on Premenstrual Syndrome Symptoms, Quality of Life, and Pain: A Randomized Controlled Clinical Trial
The study was conducted as a randomized controlled trial to evaluate the effects of foot bath application on symptom severity, quality of life, and pain levels in women with premenstrual syndrome. The research was carried out with 92 midwifery students. While foot bath therapy was applied to the experimental group, no intervention was performed in the control group. Data were collected through face-to-face interviews using the Personal Information Form, Premenstrual Symptom Scale, Visual Analog Scale, and SF-36 Quality of Life Scale.
Read the detailed description
Study Design and Participants
This study was designed as a prospective randomized controlled trial including pretest, posttest, and follow-up measurements. The study population consisted of midwifery students studying at the Faculty of Health Sciences at X University who reported symptoms of premenstrual syndrome (PMS). The sample size was calculated using the G*Power 3.1.9.7 software. Based on a medium effect size (f = 0.25), repeated measures ANOVA with two groups and three measurements, a significance level of 5% (α = 0.05), a correlation coefficient between repeated measurements of 0.50, and 80% statistical power (1-β = 0.80), the minimum required sample size was determined as 86 participants. The study was completed with 92 participants (Experimental group: 46, Control group: 46).
The study was conducted over three consecutive menstrual cycles, and data were collected at three different time points: before the intervention, at the end of the third menstrual cycle, and four weeks after completion of the intervention.
Intervention (Foot Bath Application)
Participants in the experimental group received standardized education regarding the foot bath application, and the necessary materials were provided. Participants were instructed to soak their feet in water at a temperature of 38-42 °C for 20 minutes daily during the luteal phase (7-10 days before menstruation) for three consecutive menstrual cycles. Compliance with the intervention was monitored using a daily follow-up chart, and participants received reminder messages each evening. The foot bath procedure included cleaning the feet, preparing water at the appropriate temperature, verifying the temperature using a thermometer, immersing the feet in water for the specified duration, and drying the feet after the procedure. Outcome measurements were repeated at the end of each menstrual cycle and four weeks after completion of the intervention.
Control Group
No intervention was applied to the control group, and participants were only followed throughout their menstrual cycles. Data were collected from the control group at the same time points as the experimental group (pretest, end of the third cycle, and four weeks after the intervention). After completion of the study, control group participants who requested the foot bath intervention were provided with the necessary materials in accordance with ethical principles.
- Conditions
- Premenstrual Syndrome
- Being tested
- Foot bath therapy
- Keywords
- Foot bath, Premenstrual Syndrome, Quality of life, pain
- Medical subject headings
- Premenstrual Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot bath therapyOther
Foot bath therapy was applied during the luteal phase of three menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group 1 Foot bath therapy | Experimental | Foot bath therapy Receives: Other: Foot bath therapy |
| Group 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
The Personal Information Form was developed by the researchers to determine the participants' sociodemographic and menstrual characteristics.
Measured: Pretest assessments were administered to all participants in both groups before the intervention.
Premenstrual Syndrome Scale (PMSS)
The Premenstrual Syndrome Scale (PMSS) was developed by Gençdoğan (2006) based on DSM-III and DSM-IV-TR diagnostic criteria to assess the severity of premenstrual symptoms. The scale consists of 44 items and is structured as a 5-point Likert-type instrument. Each item is rated between "Never" (1 point) and "Always" (5 points), and higher total scores indicate greater symptom severity. The scale includes nine subdimensions: depressive mood, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating.
Measured: * "Baseline 1" * "3 months later" * "4 weeks later" * "approximately 4months"
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a one-dimensional measurement tool used to assess pain intensity and was first developed by Hayes and Patterson (1921). The scale consists of a 10-cm (100 mm) horizontal or vertical line anchored by "No pain" at one end and "Unbearable pain" at the other. Participants are asked to mark the point that best represents their perceived pain intensity. The VAS is widely accepted as a reliable and sensitive tool for measuring pain severity in clinical research (Ahearn, 1997).
Measured: * "Baseline 1" * "3 months later" * "4 weeks later" * "Approximately 4months"
SF-36 Short Form
The SF-36 is a 36-item self-report instrument developed to evaluate health-related quality of life. The scale measures eight domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, energy/fatigue, social functioning, role limitations due to emotional problems, and mental well-being. Scores are calculated according to standardized scoring procedures, with higher scores indicating better quality of life. The Turkish validity and reliability of the scale were established by Demiral et al. (2006).
Measured: * "Baseline 1" * "3 months later" * "4 weeks later" * "Approximately 4months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Sep 2025
- Primary completion20 Feb 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted using a randomized controlled pretest-posttest experimental design with a follow-up assessment.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURTEN ÖZÇALKAP, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461051
- Sponsor's protocol ID
- 2024/253
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't share individual participant data with other researchers
Publications
Demiral Y, Ergor G, Unal B, Semin S, Akvardar Y, Kivircik B, Alptekin K. Normative data and discriminative properties of short form 36 (SF-36) in Turkish urban population. BMC Public Health. 2006 Oct 9;6:247. doi: 10.1186/1471-2458-6-247.
PubMed 17029646Ahearn EP. The use of visual analog scales in mood disorders: a critical review. J Psychiatr Res. 1997 Sep-Oct;31(5):569-79. doi: 10.1016/s0022-3956(97)00029-0.
PubMed 9368198Gençdoğan, B. (2006). Development of a scale for measuring premenstrual syndrome symptoms. Turkish Psychological Counseling and Guidance Journal, 3(26), 51-58.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Footbath on Premenstrual Syndrome Symptoms, Quality of Life, and Pain: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07461051
- Acronym / sponsor ID
- 2024/253
- Conditions
- Premenstrual Syndrome
- Keywords
- Foot bath, Premenstrual Syndrome, Quality of life, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 10 Mar 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.
The study was conducted as a randomized controlled trial to evaluate the effects of foot bath application on symptom severity, quality of life, and pain levels in women with premenstrual syndrome. The research was carried out with 92 midwifery students. While foot bath therapy was applied to the experimental group, no intervention was performed in the control group. Data were collected through face-to-face interviews using the Personal Information Form, Premenstrual Symptom Scale, Visual Analog Scale, and SF-36 Quality of Life Scale.
Detailed description
Study Design and Participants
This study was designed as a prospective randomized controlled trial including pretest, posttest, and follow-up measurements. The study population consisted of midwifery students studying at the Faculty of Health Sciences at X University who reported symptoms of premenstrual syndrome (PMS). The sample size was calculated using the G*Power 3.1.9.7 software. Based on a medium effect size (f = 0.25), repeated measures ANOVA with two groups and three measurements, a significance level of 5% (α = 0.05), a correlation coefficient between repeated measurements of 0.50, and 80% statistical power (1-β = 0.80), the minimum required sample size was determined as 86 participants. The study was completed with 92 participants (Experimental group: 46, Control group: 46).
The study was conducted over three consecutive menstrual cycles, and data were collected at three different time points: before the intervention, at the end of the third menstrual cycle, and four weeks after completion of the intervention.
Intervention (Foot Bath Application)
Participants in the experimental group received standardized education regarding the foot bath application, and the necessary materials were provided. Participants were instructed to soak their feet in water at a temperature of 38-42 °C for 20 minutes daily during the luteal phase (7-10 days before menstruation) for three consecutive menstrual cycles. Compliance with the intervention was monitored using a daily follow-up chart, and participants received reminder messages each evening. The foot bath procedure included cleaning the feet, preparing water at the appropriate temperature, verifying the temperature using a thermometer, immersing the feet in water for the specified duration, and drying the feet after the procedure. Outcome measurements were repeated at the end of each menstrual cycle and four weeks after completion of the intervention.
Control Group
No intervention was applied to the control group, and participants were only followed throughout their menstrual cycles. Data were collected from the control group at the same time points as the experimental group (pretest, end of the third cycle, and four weeks after the intervention). After completion of the study, control group participants who requested the foot bath intervention were provided with the necessary materials in accordance with ethical principles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was conducted using a randomized controlled pretest-posttest experimental design with a follow-up assessment.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group 1 Foot bath therapy | Experimental | Other: Foot bath therapyFoot bath therapy |
| Group 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 and 25 years of age
- Having no chronic disease
- Having a symptom severity score of 5 or higher according to the VAS,
- Voluntarily agreeing to participate in the study.
Key exclusion criteria (2 listed)
- Psychiatric disorder
- Secondary dysmenorrhea.
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 |
|---|---|---|
| Foot bath therapyFoot bath therapy was applied during the luteal phase of three menstrual cycles. | Other | Experimental: Group 1 Foot bath therapy |
Primary outcome
Personal Information Form
Time frame: Pretest assessments were administered to all participants in both groups before the intervention.
The Personal Information Form was developed by the researchers to determine the participants' sociodemographic and menstrual characteristics.
Premenstrual Syndrome Scale (PMSS)
Time frame: * "Baseline 1" * "3 months later" * "4 weeks later" * "approximately 4months"
The Premenstrual Syndrome Scale (PMSS) was developed by Gençdoğan (2006) based on DSM-III and DSM-IV-TR diagnostic criteria to assess the severity of premenstrual symptoms. The scale consists of 44 items and is structured as a 5-point Likert-type instrument. Each item is rated between "Never" (1 point) and "Always" (5 points), and higher total scores indicate greater symptom severity. The scale includes nine subdimensions: depressive mood, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating.
Visual Analog Scale (VAS)
Time frame: * "Baseline 1" * "3 months later" * "4 weeks later" * "Approximately 4months"
The Visual Analog Scale (VAS) is a one-dimensional measurement tool used to assess pain intensity and was first developed by Hayes and Patterson (1921). The scale consists of a 10-cm (100 mm) horizontal or vertical line anchored by "No pain" at one end and "Unbearable pain" at the other. Participants are asked to mark the point that best represents their perceived pain intensity. The VAS is widely accepted as a reliable and sensitive tool for measuring pain severity in clinical research (Ahearn, 1997).
SF-36 Short Form
Time frame: * "Baseline 1" * "3 months later" * "4 weeks later" * "Approximately 4months"
The SF-36 is a 36-item self-report instrument developed to evaluate health-related quality of life. The scale measures eight domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, energy/fatigue, social functioning, role limitations due to emotional problems, and mental well-being. Scores are calculated according to standardized scoring procedures, with higher scores indicating better quality of life. The Turkish validity and reliability of the scale were established by Demiral et al. (2006).
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 28 Aug 2026.
- Results publication: PubMed 17029646Demiral Y, Ergor G, Unal B, Semin S, Akvardar Y, Kivircik B, Alptekin K. Normative data and discriminative properties of short form 36 (SF-36) in Turkish urban population. BMC Public Health. 2006 Oct 9;6:247. doi: 10.1186/1471-2458-6-247.
- Results publication: PubMed 9368198Ahearn EP. The use of visual analog scales in mood disorders: a critical review. J Psychiatr Res. 1997 Sep-Oct;31(5):569-79. doi: 10.1016/s0022-3956(97)00029-0.
- Results publicationGençdoğan, B. (2006). Development of a scale for measuring premenstrual syndrome symptoms. Turkish Psychological Counseling and Guidance Journal, 3(26), 51-58.
- Individual participant dataSharing planned: No. we don't share individual participant data with other researchers
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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 Foot bath therapy in people with Premenstrual Syndrome, run by Agri Ibrahim Cecen 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 4 inclusion and 2 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 28 Aug 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?
Personal Information Form (time frame: Pretest assessments were administered to all participants in both groups before the intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07461051, which also lists 3 linked publications.
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 28 Aug 2026.