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

NCT ID: NCT06585475

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-08-05

Brief Summary

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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

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Conditions

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Premenstrual Syndromes Education Menstrual Cycle Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Structured training according to premenstrual syndrome symptom map

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sakarya University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sakarya University

Sakarya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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23.08.2024

Identifier Type: -

Identifier Source: org_study_id

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