An interventional study of foot bath intervention in Premenstrual Syndrome, sponsored by Hüsne YÜCESOY. Completed at 2 sites in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Hüsne YÜCESOY · Not applicable, Interventional, and Screening
Premenstrual syndrome is a cyclical disorder characterized by physical and emotional symptoms that appear in the late luteal phase of the menstrual cycle and subside within a few days with the onset of menstruation. Non-pharmacological methods should be recommended first to women who experience PMS symptoms. For this purpose, it is planned to apply foot bath to university students with premenstrual syndrome.
The study was planned as a randomized controlled single-blind study. The universe of the research will be female students studying at Ordu University Faculty of Education in the 2021-2022 academic year. In the first stage of the study, female students who are 18 years of age and older and who voluntarily agree to participate in the research will be taken without making a sample selection. Considering the possibility of data loss during the research process, it was planned to work on 39 intervention and 39 control groups, including a total of 78 women In the collection of data; Personal Information Form, Premenstrual Syndrome Scale (PMSS), Pittsburgh Sleep Quality Index (PSQI), SF-36 Quality of Life Scale will be used. PSQI and SF-36 Quality of Life Scale will be applied to students in the intervention group. The foot bath will be applied for 3 months, starting 7-10 days before the menstrual cycle, that is, in the luteal phase of the menstrual cycle. Students will be asked to fill out the Footbath Monitoring Form in order to assess whether they have taken a footbath. Those who apply foot bath at least 7 times will be included in the study. In case of less than seven students, the student will be excluded from the research and the new student who meets the criteria will be included in the research. At the end of each cycle, PMSÖ, PSQI and SF-36 will be administered to the students by the researcher. When the students in the Control Group are determined, PSQI and SF-36 will be applied by the researcher, and then PMSÖ, PSQI and SF-36 will be applied at the end of each cycle.
Premenstrual syndrome is a cyclical disorder characterized by physical and emotional symptoms that appear in the late luteal phase of the menstrual cycle and subside within a few days with the onset of menstruation. Although the etiology is not known precisely, many factors are thought to be effective. Premenstrual symptoms that occur in the second half of the menstrual cycle negatively affect the lives of many women. Pharmacological, non-pharmacological and surgical methods are used as treatment methods. Non-pharmacological methods should be recommended first to women who experience PMS symptoms. Non-pharmacological methods have advantages such as increasing the effectiveness of analgesic drugs, reducing the need for drugs, preventing the side effects of the drug and not bringing too much economic burden. For this purpose, it is planned to apply foot bath to university students with premenstrual syndrome. Although many studies have been conducted both in our country and abroad on university students' coping with PMS, no study has been found that investigates the effect of foot bathing on premenstrual syndrome severity, sleep quality and quality of life to cope with PMS.
The study was planned as a randomized controlled single-blind study. The universe of the research will be female students studying at Ordu University Faculty of Education in the 2021-2022 academic year. In the first stage of the study, female students who are 18 years of age and older and who voluntarily agree to participate in the research will be taken without making a sample selection. The number of students to be included in the intervention and control groups of the research will be determined according to the results of the power analysis in the G-Power 3.1.9.7 program. Considering the possibility of data loss during the research process, it was planned to work on 39 intervention and 39 control groups, including a total of 78 women, 10% of the calculated sample size. In the collection of data; Personal Information Form, Premenstrual Syndrome Scale (PMSS), Pittsburgh Sleep Quality Index (PSQI), SF-36 Quality of Life Scale will be used. PSQI and SF-36 Quality of Life Scale will be applied to students in the intervention (footbath) group by the researcher. Students will be given footbath practice training, which takes approximately 30-40 minutes. During the training, it will be shown how to apply foot bath. The foot bath will be applied for 3 months, starting 7-10 days before the menstrual cycle, that is, in the luteal phase of the menstrual cycle. The researcher will send a reminder message to the students every day for 7-10 days, starting 7-10 days before the period according to the previous menstrual period of the students. Students will be asked to fill out the Footbath Monitoring Form in order to assess whether they have taken a footbath. Those who apply foot bath at least 7 times will be included in the study. In case of less than seven students, the student will be excluded from the research and the new student who meets the criteria will be included in the research. At the end of each cycle, PMSÖ, PSQI and SF-36 will be administered to the students by the researcher. When the students in the Control Group are determined, PSQI and SF-36 will be applied by the researcher, and then PMSÖ, PSQI and SF-36 will be applied at the end of each cycle.
In this study, the effect of applying foot bath to university students with premenstrual syndrome on premenstrual syndrome symptoms, sleep quality and quality of life will be determined. It is thought that the low-cost, easy-to-apply foot bath will reduce symptoms and increase sleep quality and quality of life in women with PMS. As a result of the research, it will be possible to ensure that this application is among the other non-pharmacological methods used to cope with PMS and its use will become widespread. Thus, by increasing the sleep quality and quality of life of university students who are adversely affected by PMS symptoms, their school, work and social lives will be changed positively, and positive contributions will be made to their daily lives.
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 77 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.
Browse Syndrome studies →This is the only study on the registry with Hüsne YÜCESOY as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
foot bath intervention
Other: foot bath intervention
follow-up
Students in this group will have their feet soaked in water with a temperature of 38-42 degrees for 20 minutes, half an hour before bedtime.
Premenstrual Syndrome Scale
Students with PMS will be determined by applying the personal information form and PMSÖ to the students who accept to participate in the research. Then, PMSÖ, 1st, 2nd and 3rd cycles according to the groups. PMSÖ has nine sub-dimensions and consists of 44 questions. The lowest 44, the highest 220 points are taken from the scale. A high score indicates a greater intensity of PMS symptoms.
Time frame: 20 minutes
Pittsburgh Sleep Quality Index
After the students with PMS are identified, an intervention and control group will be formed. PSQI will be applied to students in the intervention and control groups. Then, at the end of the 1st, 2nd and 3rd cycles, the Pittsburgh Sleep Quality Index will be applied.The PSQI score has a value between 0-21. A total PSQI score of 5 or less indicates good sleep quality, and a total of 6 and above indicates poor sleep quality.The PSQI score has a value between 0-21. A total PSQI score of 5 or less indicates good sleep quality, and a total of 6 and above indicates poor sleep quality.
Time frame: 20 minutes
SF-36 Quality of Life Scale
After the students with PMS are identified, an intervention and control group will be formed. SF-36 Quality of Life Scale will be applied to students in the intervention and control groups. Then, at the end of the 1st, 2nd and 3rd cycles, the SF-36 Quality of Life Scale will be applied. From the SF-36 Quality of Life Scale, "0" indicates the lowest and "100" indicates the best level of life.
Time frame: 10 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.