CClinicalTrials.gg
CompletedNCT05264519Updated Dec 11, 2024

The Effect of Foot Bath on PMS, Sleep and Quality of Life Among University Students With PMS

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

Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Premenstrual Syndrome

Keywords

  • Premenstrual Syndrome
  • Nursing
  • Foot Bath
  • Sleep Quality
  • Life Quality
03

In context

Syndrome

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 →

Lead sponsor

This is the only study on the registry with Hüsne YÜCESOY as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • be 18 years or older,
  • Getting 111 points or more from the Premenstrual Syndrome Scale
  • Being single
  • Having a regular menstrual cycle for the last 6 months (every 21-35 days and no intermittent bleeding),
  • Having a Body Mass Index (BMI) between 19-24.9,
  • Not using cigarettes or alcohol,
  • Not receiving medical treatment for PMS,
  • Not receiving treatment for insomnia,

Exclusion criteria

Exclusion Criteria:

  • Having a psychiatric diagnosis
  • Having a gynecological disease,
  • Doing regular exercise,
  • Using hormonal contraception (such as oral contraceptives and injections),
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    intervention

    foot bath intervention

    Other: foot bath intervention

  • No intervention
    control

    follow-up

Interventions

  • Otherfoot bath intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

07

Study locations

2 sites
  • Ordu Üniversitesi
    Ordu, Altınordu 52200, Turkey
  • Ordu University
    Ordu, Centre 52200, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05264519
Lead sponsor
Hüsne YÜCESOY
Responsible party
Hüsne YÜCESOY (PROF. DR., T.C. ORDU ÜNİVERSİTESİ) — Sponsor-investigator
First posted
Mar 3, 2022
Start date
Nov 6, 2021
Primary completion
Mar 30, 2022
Completion
Sep 30, 2022
Last update
Dec 11, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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