NCT06644365

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

15 days

First QC Date

October 13, 2024

Last Update Submit

October 15, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

Study Arms (2)

control group

PLACEBO COMPARATOR

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

intervention group

EXPERIMENTAL

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

Interventions

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.

intervention group

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.

control group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof.

Study Record Dates

First Submitted

October 13, 2024

First Posted

October 16, 2024

Study Start

November 15, 2024

Primary Completion

November 30, 2024

Study Completion

March 30, 2025

Last Updated

October 16, 2024

Record last verified: 2024-10