Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms

Examining the Effect of Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms in Students Experiencing Premenstrual Syndrome: Randomized Controlled Study

Purpose of the study: To examine the effect of acupressure mat on perceived stress, sleep quality and premenstrual symptoms in students with premenstrual syndrome.

Hypotheses of the study;

In the post-test and follow-up test between students who were applied acupressure mat and those who were applied plain mat;

H10: There is no difference in terms of severity of premenstrual symptoms.

H20: There is no difference in terms of perceived stress.

H30: There is no difference in terms of sleep quality.

Study Overview

• Status: Not yet recruiting
• Conditions: Premenstrual Symptoms; Effect of Acupressure Mat
• Intervention / Treatment: Other: Basic mat; Other: Acupresure mat

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Using medication and/or non-medical methods to cope with PMS
• Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
• Using contraceptive medication.

Exclusion Criteria:

• Participants wanting to withdraw from the study at any stage of the study
• Participants not complying with the research plan
• Diagnosed with a psychiatric or gynecological disease during the study
• Participants starting to receive additional treatment for PMS during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; Students will be given a placebo exercise on a flat yoga/exercise mat on the same days, in the same way and for the same duration as the intervention group.	Other: Basic mat; The Premenstrual Syndrome Scale will be applied and the scale results will be evaluated. Participants who score 132 and above on the scale will be considered to be experiencing PMS. The intervention will be made in the second phase of the study.Participants in this group will also be sent a reminder message similar to the intervention group. This practice will continue for three menstrual cycles.
Experimental: intervention group; They will be asked to lie on the acupressure mat for 15 minutes once a day, 3 days a week (Monday, Wednesday, Friday). A reminder message will be sent on the morning of the application so that participants do not forget and are motivated. After each application, participants will be asked to fill out the session monitoring chart.	Other: Acupresure mat; The Premenstrual Syndrome Scale will be applied and the scale results will be evaluated. Participants who score 132 and above on the scale will be considered to be experiencing PMS. The intervention will be made in the second phase of the study.This practice will continue for three menstrual cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premenstrual Syndrome Symptom Scale	It was developed by Gençdoğan (2006) to measure the severity of premenstrual symptoms. The scale consists of 44 questions that measure the severity of premenstrual symptoms based on DSM-III and DSM-IV-R. It is a five-point Likert-type scale. In the scoring of the scale, the option "Never" is given 1 point, the option "Very little" is given 2 points, and the option "Sometimes" is given 3 points.	just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
Perceived Stress Scale	The scale was developed by Cohen et al. in 1983 to measure the stress a person perceives in a given situation and was adapted to Turkish by Eskin et al. (2013). The 5-point Likert-type scale (Never (0)-Very often (4)) contains a total of 14 items. 7 items with positive expressions are scored in reverse. The minimum score from 0 to a maximum of 56 points can be obtained from the scale. A high score indicates that the person is highly stressed.	just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
Visual Analog Scale (VAS) Sleep Quality	Students will be asked to evaluate their sleep quality with the Visual Analog Scale. VAS-sleep quality is a 10 cm long tool. "My sleep quality is very poor" is written on the left end of the scale and "My sleep quality is very good" is written on the right. A score of 10 from the scale indicates that sleep quality is high, while a score of 0 indicates that sleep quality is very poor.	just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).

Collaborators and Investigators

• Sponsor: Gulhane School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024 (Other Grant/Funding Number: Rome Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No