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Clinical Trials/NCT06585475
NCT06585475
Completed
Not Applicable

The Effectiveness of Structured Training According to the Premenstrual Syndrome Symptom Map

Sakarya University1 site in 1 country101 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premenstrual Syndromes
Sponsor
Sakarya University
Enrollment
101
Locations
1
Primary Endpoint
VAS pain score
Status
Completed
Last Updated
last year

Overview

Brief Summary

In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Women who met the inclusion criteria and volunteered to participate in the study constituted the sample of the study. As a result of block randomisation, 55 women were assigned to the intervention group and 55 women to the control group. Pre-test data were collected from the women allocated to the intervention and control groups by means of data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, Premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). The intervention group received a 3-session structured training according to the PMS symptom map, while the control group did not receive any intervention. Women in the intervention group completed the post-test data on the last day of the 2nd cycle after the training, while women in the control group completed the post-test data on the last day of the 2nd cycle after the pre-test.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
August 5, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Sakarya University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Meeting ACOG's PMS diagnostic criteria Being over 18 years of age, Not using psychotherapeutic medications, Not having a mental illness, Not being pregnant, Agreeing to participate in the study

Exclusion Criteria

  • Not having regular menstruation in the last 3 months, Using analgesics during menstruation while participating in the study.

Outcomes

Primary Outcomes

VAS pain score

Time Frame: pre-intervention, 2 month after intervention

1.421 / 5.000 VAS pain score measures pain score

Premenstrual syndrome assessment scale

Time Frame: pre-intervention, 2 month after intervention

a scale used to measure the degree of premenstrual syndrome

premenstrual syndrome specific life satisfaction scale

Time Frame: pre-intervention, 2 month after intervention

Premenstrual syndrome specific life satisfaction scale evaluates life satisfaction of women with PMS

DAS depression stress anxiety assessment scale

Time Frame: pre-intervention, 2 month after intervention

DAS depression stress anxiety assessment scale, evaluates psychological symptoms

Study Sites (1)

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