Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:28 AM
Study NCT ID:
NCT07461051
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Foot Bath Therapy on Premenstrual Syndrome Symptoms, Quality of Life, and Pain
Sponsor:
Inonu University
Organization:
Study Overview
Official Title:
The Effects of Footbath on Premenstrual Syndrome Symptoms, Quality of Life, and Pain: A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: