Foot Reflexology Massage
BehavioralFoot 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,
NCT Number: NCT07803497
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 opening soon.
Get Notified18 year–25 year
Female
Interventional
Not applicable
This study aims to evaluate the effects of a reflexology program applied to university students on premenstrual syndrome symptoms, quality of life, and overall comfort. The study was planned as a randomized controlled trial with intervention and control groups. The main questions targeted by the reflexology application are:
Is a reflexology program applied to the foot area significantly effective in reducing the severity of premenstrual syndrome symptoms experienced by students? Is a reflexology program applied to the foot area significantly effective in improving the quality of life experienced by students with premenstrual syndrome symptoms? Is a reflexology program applied to the foot area significantly effective in improving overall comfort experienced by students with premenstrual syndrome symptoms? The study population will consist of 1571 female students aged 18-25 studying at Balıkesir University Necatibey Faculty of Education between January 2026 and September 2027. The departments in this faculty are as follows: Computer and Instructional Technologies Teaching, Biology Teaching, Science Teaching, Primary School Mathematics Teaching, English Teaching, Chemistry Teaching, Mathematics Teaching, Preschool Teaching, Guidance and Psychological Counseling, and Classroom Teaching (10 departments). Instead of sampling, the "Individual Information Form and Premenstrual Syndrome Scale (PMSÖ)" will be administered. At the end of this research, from the female students identified as having PMS (1st year: 306; 2nd year: 394; 3rd year: 425; 4th year: 446), an intervention group and a control group will be selected by lottery, without sampling. These students will also be administered the "Premenstrual Syndrome-Specific Quality of Life Scale and General Comfort Scale Short Form" in a randomized controlled trial design.
Using the G Power 3.1.9.7 program, with a 0.05 confidence interval, 90% power, and an effect size of 0.7 (Cohen's d: 0.7), the sample size was calculated to consist of at least 44 female students in each group, totaling 88 students. However, considering the possibility of loss during application and follow-up, reflexology treatment will be applied to 10% or more of these students. Therefore, 60 students will receive the reflexology program. The effect size value (Cohen's d: 0.7) is similar to that found in randomized controlled trials in the literature, where reflexology significantly reduced premenstrual syndrome symptoms and resulted in an above-average effect size.
The female students in the intervention group will then undergo a reflexology program consisting of 12 sessions per week, each lasting 30 minutes, for three months, starting 10 days before menstruation and continuing until the first day of menstruation. The reflexology application will include:
-Each student will receive 12 sessions per month, four days a week, each session lasting 30 minutes, for a total of 12 sessions over three months, starting 10 days before the start of menstruation and continuing until the first day of menstruation.
Initially, 10 minutes of foot warm-up exercises and applications to increase blood flow to the brain, spinal cord, vagus nerve, upper and lower lymph nodes, sinuses, and solar plexus will be performed on the right foot. Then, 20 minutes of exercises focusing on the brain, spinal cord, vagus nerve, uterus, etc., will be performed on the left foot. Reflexology treatment can provide relief by targeting the ovaries, urogenital organs including the fallopian tubes, upper and lower lymph nodes, intestines, and hip joint.
articipants will also be advised to consume an extra 500 ml of water throughout the day after each reflexology session to help flush out toxins released from the body.
At the end of the third month, the Premenstrual Symptom Scale, the Premenstrual Syndrome-Specific Quality of Life Scale, and the General Comfort Scale Short Form will be administered as final tests to the students in the intervention group. Additionally, the Premenstrual Symptom Scale, the Premenstrual Syndrome-Specific Quality of Life Scale, and the General Comfort Scale Short Form will also be administered as final tests to the students in the control group during this period. After two menstrual cycles following the completion of the reflexology program, the intervention and control groups will also be administered the "Premenstrual Syndrome Scale (PMS), Premenstrual Syndrome-Specific Quality of Life Scale, and General Comfort Scale Short Form" via face-to-face interviews for follow-up purposes. If this is not possible, students will be asked to complete these scales via the "Google Forms" application and send them to the researcher. After the follow-up test, participants in both the intervention and control groups will receive an "Informative PMS and Reflexology Booklet." The data obtained in the research will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 30.0 program. Descriptive statistical methods will be used in the evaluation of the data, with frequency and percentage for categorical variables and mean and standard deviation for numerical variables.
When comparing two independent groups in terms of continuous numerical data, the Independent Sample t-test will be used if parametric test rules are suitable, and the Mann-Whitney U test will be used if the conditions for nonparametric tests are met between the two groups being compared.
When comparing continuous numerical data between more than two independent groups, the ANOVA test will be applied if parametric test rules are suitable, and the Kruskal-Whallis test will be applied if nonparametric conditions exist (n<30). The Chi-square test will be used to compare categorical data in independent groups, Pearson correlation analysis will be used to examine the linear relationship between numerical data, and regression analysis will be used to test the effectiveness of the obtained models when comparing multivariate data. To examine the differences between the pre-test and post-test, the Paired Sample t-test will be used if the assumption of normal distribution is met, and the Wilcoxon test will be used if it is not met. The significance level will be considered 0.05.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
-
Exclusion criteria
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.
-
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,
Time frame: Baseline (before intervention) 3 months after intervention 5 months after intervention
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.
Time frame: Baseline (before intervention) 3 months after intervention 5 months after intervention
The Premenstrual Syndrome-Specific Quality of Life Scale, developed by Hadavi Bavili and İlçioğlu in 2024 and whose validity and reliability analysis has been conducted, will be used. This scale, consisting of 22 items covering three sub-dimensions-emotional, physical, and social-is scored using reverse coding. The PMS Scale is a 22-item, 5-point Likert-type, single-dimensional scale (Strongly disagree, Disagree, Undecided, Agree, Strongly agree). A minimum score of 22 and a maximum score of 110 can be obtained. It is a scale that shows how PMS symptoms experienced by women affect their quality of life from a holistic perspective. Here;
Questions 1-11: Social well-being dimension; Questions 12-18: Emotional dimension; Questions 19-22: Physical dimension.
Time frame: Baseline (before intervention) 3 months after intervention 5 months after intervention
The "General Comfort Scale Short Form", adapted into Turkish by Çıtlık Sarıtaş et al. (2018) and subjected to validity and reliability analysis, will be used. The General Comfort Scale Short is a 28-item, 6-point Likert-type, one-dimensional scale (Strongly Disagree "1" and Strongly Agree "6"). Items containing negative statements are reverse-coded. Sub-dimensions of the General Comfort Scale Short Form: Kolcaba conducted studies on comfort theory and explained this theory through dimensions and levels. The sub-dimensions are; The Comfort Scale consists of three sub-dimensions: Relaxation (state of contentment, calmness, or satisfaction), Overcoming (a state where one has overcome their pain or problems), and Relief (a patient's state of having a specific need met) (Kolcaba, 2003; Çınar, 2011; Kolcaba, 1992; Karabacak and Acaroğlu, 2011). The GKÖ-KF (Generalized System of Comfort) was developed by Kolcaba in 2006. Comfort comprises three sub-dimensions: relaxation (9 items), overcomin
Contact information is provided by the study sponsor or research team.
Gülendam KARADAĞ, PROFESSOR
CONTACT
Nurcan Karakoç, PHD STUDENT
CONTACT
Dokuz Eylul University
Other
THE EFFECT OF A REFLEXOLOGY PROGRAM APPLİED TO UNİVERSİTY STUDENTS ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07789626
Menstruation Disturbances, Pathologic Processes
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07097558
Mandala Coloring, Menstruation Disturbances
Istanbul, AVCILAR, Turkey (Türkiye)
View Trial DetailsNCT07013539
Menstruation Disturbances, Pathologic Processes
Rende, Cosenza, Italy
View Trial DetailsNCT07599436
Behavior, Dyssomnias
Ankara, Turkey (Türkiye)
View Trial Details