NCT07803497

Brief Summary

This study aims to evaluate the effect of foot reflexology on premenstrual syndrome symptoms, quality of life, and comfort levels among university students with premenstrual syndrome. The study will be conducted as a randomized controlled experimental study. Participants will be assigned to intervention and control groups. The intervention group will receive 30-minute foot reflexology sessions four times a month for three months, while the control group will receive no intervention. The outcomes will be assessed before and after the intervention.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026May 2027

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

University students, reflexology, premenstrual syndrome, quality of life, general comfort.

Outcome Measures

Primary Outcomes (1)

  • The effect of foot reflexology massage on Premenstrual Syndrome Symptoms

    In this study, the Premenstrual Syndrome Scale, developed by Gençdoğan in 2006 and whose validity and reliability have been analyzed, will be used to determine the level of PMS and PMS symptoms. The PMS Scale is a 44-item, 5-point Likert-type scale with nine sub-dimensions (Never, Very little, Sometimes, Frequently, Constantly). "Never" is interpreted as 1 point and "Constantly" as 5 points. The PMS Scale is scored by summing the scores for the nine sub-dimensions and the total score obtained from all sub-dimensions. The lowest possible score on the scale is 44, and the highest is 220. A higher score indicates more severe PMS symptoms. A score greater than 50% of the maximum possible 220 on the scale indicates the presence of PMS. In this case, individuals scoring 111 or higher on the PMSQ are evaluated for PMS symptoms. It is concluded that the intensity and severity of PMS symptoms increase proportionally with the increasing scores.

    Baseline (before intervention) 3 months after intervention 5 months after intervention

Secondary Outcomes (1)

  • The effect of foot reflexology massage on quality of life.

    Baseline (before intervention) 3 months after intervention 5 months after intervention

Other Outcomes (1)

  • The effect of foot reflexology massage on overall comfort

    Baseline (before intervention) 3 months after intervention 5 months after intervention

Study Arms (2)

İnterventiön Group

EXPERIMENTAL

Participants in this group will receive foot reflexology massage for 3 months, with 4 sessions per month. Each session will last 30 minutes, for a total of 12 sessions

Behavioral: Foot Reflexology Massage

Control Group

NO INTERVENTION

Bu gruptaki katılımcılar çalışma süresi boyunca herhangi bir müdahale almayacaklardır. Ön test ve son test değerlendirmeleri yapılacaktır

Interventions

Foot reflexology massage will be administered to participants in the intervention group for 3 months, with 4 sessions per month. Each session will last 30 minutes, for a total of 12 sessions,

İnterventiön Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female students aged 18-25 attending the 1st, 2nd, and 3rd years at Balıkesir University Necatibey Faculty of Education, Students who have had regular menstrual cycles for the past three months and meet the following conditions; Students who, according to FIGO, have their periods every 24-38 days and have menstrual bleeding lasting 4-8 days.
  • Students who have not undergone a major surgical operation (abdominal or cardiovascular surgery such as TAH+BSO, myomectomy, cesarean delivery, etc., thoracic surgery, varicose vein surgery, organ transplant, etc.) in the last six months, Those who do not use oral contraceptives or IUDs, Those who do not use menstrual regulating medication under doctor's supervision, Those who are not pregnant, Students who do not have gynecological problems (PCOS, endometriosis, adenomyosis, dysmenorrhea, etc.), Students who do not consume herbal teas or use painkillers to alleviate menstrual pain will be included in the study.

You may not qualify if:

  • Individuals with cardiovascular diseases such as deep vein thrombosis, Individuals with gynecological diseases (uterine fibroids, polycystic ovary syndrome, endometriosis, adenomyoma, polyps, etc.), Individuals with lesions that may prevent standing reflexology application, such as tinea pedis, Female students who cannot communicate in Turkish will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nurcan Karakoç

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurcan Karakoç, PHD STUDENT

CONTACT

Gülendam KARADAĞ, PROFESSOR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled intervention study with two parallel groups. Participants in the intervention group will receive foot reflexology for 30 minutes per session, 4 sessions per month for 3 months, for a total of 12 sessions. No intervention will be provided to the control group. Pre-test and post-test measurements will be conducted and compared between the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD. STUDENT

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share