Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05264519 |
| Other study ID # |
HY1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 6, 2021 |
| Est. completion date |
August 2022 |
Study information
| Verified date |
March 2022 |
| Source |
T.C. ORDU ÜNIVERSITESI |
| Contact |
Hüsne Hemsire |
| Phone |
04522265200 |
| Email |
husne_yucesoy[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
