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

NCT07461051 | Completed

• 1 other identifier: 2024/253
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

Foot bath; Premenstrual Syndrome; Quality of life; pain

Outcome Measures

Primary Outcomes (4)

• 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"

Study Arms (2)

Experimental: Group 1 Foot bath therapy

EXPERIMENTAL

Foot bath therapy

Other: Foot bath therapy

Group 2

NO INTERVENTION

Interventions

Foot bath therapy OTHER

Foot bath therapy was applied during the luteal phase of three menstrual cycles.

Experimental: Group 1 Foot bath therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with premenstrual syndrome (PMS)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Psychiatric disorder
• Secondary dysmenorrhea.

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead

Study Sites (1)

İnonü Universty

Ağrı, Ağrı, 04100, Turkey (Türkiye)

Location

Related Publications (3)

• 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

  RESULT

• Ahearn, E. P. (1997). The use of visual analog scales in mood disorders: A critical review. Journal of Psychiatric Research, 31(5), 569-579.

  RESULT

• Gençdoğan, B. (2006). Development of a scale for measuring premenstrual syndrome symptoms. Turkish Psychological Counseling and Guidance Journal, 3(26), 51-58.

  RESULT

MeSH Terms

Conditions

Premenstrual Syndrome; Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: This study was conducted using a randomized controlled pretest-posttest experimental design with a follow-up assessment.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 10, 2026
• Study Start: August 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)