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

NCT06585475 | Completed DMC

• 1 other identifier: 23.08.2024
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndromes; Education; Menstrual Cycle Disorder

Keywords

life satisfaction; pain; depression; stress; anxiety

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Structured training according to premenstrual syndrome symptom map BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, 54050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Menstruation Disturbances; Personal Satisfaction; Pain; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: November 1, 2023
• Primary Completion: June 10, 2024
• Study Completion: August 5, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)