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NCT Number: NCT06585475

Investigation of the Effectiveness of Structured Education According to 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.

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Key information

Conditions

Premenstrual Syndromes Anxiety Disorders Behavior Behavioral Symptoms Depression Education Menstrual Cycle Disorder Menstruation Disturbances Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Premenstrual Syndrome Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University

Sakarya, 54050, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Premenstrual syndrome assessment scale

    Time frame: pre-intervention, 2 month after intervention

    a scale used to measure the degree of premenstrual syndrome

  2. 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

  3. DAS depression stress anxiety assessment scale

    Time frame: pre-intervention, 2 month after intervention

    DAS depression stress anxiety assessment scale, evaluates psychological symptoms

  4. VAS pain score

    Time frame: pre-intervention, 2 month after intervention

    1.421 / 5.000 VAS pain score measures pain score

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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