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

Not Applicable

Completed

• Conditions: Premenstrual Syndromes; Education; Menstrual Cycle Disorder
• Interventions: Behavioral: Structured training according to premenstrual syndrome symptom map

• Registration Number: NCT06585475
• Lead Sponsor: Sakarya University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-06-10
• Study Completion: 2024-08-05
• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Last Update Submitted: 2024-09-03
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Structured training according to premenstrual syndrome symptom map	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sakarya University; 🇹🇷 Sakarya, Turkey