Effects of Foot Bath Therapy on Premenstrual Syndrome Symptoms, Quality of Life, and Pain

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.

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Other: Foot bath therapy

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ağrı
    • Ağrı, Ağrı, Turkey (Türkiye), 04100
      • İnonü Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Psychiatric disorder
• Secondary dysmenorrhea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 2
Experimental: Experimental: Group 1 Foot bath therapy; Foot bath therapy	Other: Foot bath therapy; Foot bath therapy was applied during the luteal phase of three menstrual cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Information Form	The Personal Information Form was developed by the researchers to determine the participants' sociodemographic and menstrual characteristics.	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.	* "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).	* "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).	* "Baseline 1" * "3 months later" * "4 weeks later" * "Approximately 4months"

Collaborators and Investigators

• Sponsor: Agri Ibrahim Cecen University

Publications and helpful links

General Publications

• Demiral, Y., Ergor, G., Unal, B., Semin, S., Akvardar, Y., Kivircik, B., & Alper, Z. (2006). Normative data and discriminative properties of short form 36 (SF-36) in Turkish urban population. BMC Public Health, 6, 247. https://doi.org/10.1186/1471-2458-6-247
• Ahearn, E. P. (1997). The use of visual analog scales in mood disorders: A critical review. Journal of Psychiatric Research, 31(5), 569-579.
• Gençdoğan, B. (2006). Development of a scale for measuring premenstrual syndrome symptoms. Turkish Psychological Counseling and Guidance Journal, 3(26), 51-58.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pain; Quality of life; Premenstrual Syndrome; Foot bath
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathologic Processes; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Premenstrual Syndrome
• Other Study ID Numbers: 2024/253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we don't share individual participant data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No