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

NCT05264519 | Completed

• 1 other identifier: HY1
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Syndrome; Nursing; Foot Bath; Sleep Quality; Life Quality

Outcome Measures

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.

  20 minutes

Secondary Outcomes (1)

• Pittsburgh Sleep Quality Index

  20 minutes

Other Outcomes (1)

• SF-36 Quality of Life Scale

  10 minutes

Study Arms (2)

intervention

EXPERIMENTAL

foot bath intervention

Other: foot bath intervention

control

NO INTERVENTION

follow-up

Interventions

foot bath intervention OTHER

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.

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Hüsne YÜCESOY: lead

Study Sites (2)

Ordu Üniversitesi

Ordu, Altınordu, 52200, Turkey (Türkiye)

Location

Ordu University

Ordu, Centre, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROF. DR.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: March 3, 2022
• Study Start: November 6, 2021
• Primary Completion: March 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)