Investigation of the Effectiveness of Structured Education According to Premenstrual Syndrome Symptom Map

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

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.

Study Overview

• Status: Completed
• Conditions: Education; Menstrual Cycle Disorder; Premenstrual Syndromes
• Intervention / Treatment: Behavioral: Structured training according to premenstrual syndrome symptom map

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sakarya, Turkey, 54050
    • Sakarya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The intervention group received a 3-session PMS symptom map-structured training by the responsible and first author (ADK). Before the training, pre-test data were collected using data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). After the training, post-test data were collected on the last day of the 1nd cycle.	Behavioral: Structured training according to premenstrual syndrome symptom map; A symptom map consisting of evidence-based practices for coping with PMS symptoms was created. An educational content based on this map was prepared and applied to women with PMS to evaluate whether it was effective compared to the control group.
No Intervention: Control group; No intervention was applied to the control group. After the participants were divided into groups by randomization, pre-test data were collected using data collection tools (VAS pain scoring, DAS depression stress anxiety rating scale, premenstrual syndrome rating scale and premenstrual syndrome specific life satisfaction scale). After the pre-test, post-test data were collected on the last day of the cycle after 1 menstrual cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premenstrual syndrome assessment scale	a scale used to measure the degree of premenstrual syndrome	pre-intervention, 2 month after intervention
premenstrual syndrome specific life satisfaction scale	Premenstrual syndrome specific life satisfaction scale evaluates life satisfaction of women with PMS	pre-intervention, 2 month after intervention
DAS depression stress anxiety assessment scale	DAS depression stress anxiety assessment scale, evaluates psychological symptoms	pre-intervention, 2 month after intervention
VAS pain score	1.421 / 5.000 VAS pain score measures pain score	pre-intervention, 2 month after intervention

Collaborators and Investigators

• Sponsor: Sakarya University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Estimated): September 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: pain; depression; anxiety; stress; life satisfaction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Menstruation Disturbances; Premenstrual Syndrome
• Other Study ID Numbers: 23.08.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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