AzTrials
AzTrials

Premenstrual SyndromeNCT05264519

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

A study testing foot bath intervention in people with Premenstrual Syndrome, run by Hüsne YÜCESOY at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Premenstrual Syndrome
What is being tested?
foot bath intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
2 sitesTurkey (Türkiye)
Study dates
6 Nov 2021to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Ordu Üniversitesi

    Ordu, Altınordu, 52200

  • Ordu University

    Ordu, Centre, 52200

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Foot Bath on Premenstrual Syndrome, Sleep Quality and Quality of Life Among University Students With Premenstrual Syndrome

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.

Being tested
foot bath intervention
Keywords
Premenstrual Syndrome, Nursing, Foot Bath, Sleep Quality, Life Quality
Medical subject headings
Premenstrual Syndrome, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • foot bath interventionOther

    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.

Study groups in NCT05264519
Study groupRoleWhat they receive
interventionExperimentalfoot bath intervention
Receives: Other: foot bath intervention
controlNo interventionfollow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 20 minutes

Secondary outcomes (1)
  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.

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start6 Nov 2021
  3. Primary completion30 Mar 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05264519
Sponsor's protocol ID
HY1
Status last verified
Dec 2024
First submitted
22 Nov 2021
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing foot bath intervention in people with Premenstrual Syndrome, run by Hüsne YÜCESOY at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Premenstrual Syndrome Scale (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in