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Completed

NCT Number: NCT04838691

Premenstrual Syndrome and Interpersonal Counseling

This study aims to test the effectiveness of interpersonal counseling in PMS symptom management in university students experiencing PMS symptoms.

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

About this study

People diagnosed with Premestrual Syndrome were identified through an online questionnaire. 80 people who were identified and accepted to study were divided into two groups as experiment and control. Initially, pre-menstrual screening tool, interpersonal relationship dimensions scale and perceived stress scale were applied to all groups. Then, 8 sessions of interpersonal counseling, each lasting 40 minutes, were applied to the experimental group for 2 months. Scales were repeated for both groups after the application was completed. Repeated measurements were made 3 months later.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • According to the Pre-menstrual Symptom Screening Instrument, which is located in the group living with AES (Pre-Mental Syndrome)
  • between the ages of 18-30
  • Menstruating at regular intervals for at least 2 years (21-35 days)
  • Those who have never given birth
  • Speak and understand Turkish
  • It will consist of people who have not received antidepressant, oral contraceptive or hormone therapy for any reason.

Exclusion criteria

  • Having a known gynecological disease (endometriosis, polycystic ovary, ...)
  • A known, ongoing physical health problem (diabetes, rheumatic disease, ...)
  • Any psychiatric disease diagnosed (psychotic disorder, mood disorder, anxiety disorder ...)
  • People who use cigarettes, alcohol or substances

Treatment and study plan

interpersonal counseling

Behavioral

In the intervention group, it will be administered for 40 minutes for 8 weeks to people with symptoms of premenstrual syndrome.

Primary outcomes

  1. Premenstrual Symptom Screening Tool

    Time frame: Baseline (beginning), Change from Baseline PMDD or PMS after 2 months, Change from Baseline PMDD or PMS after 5 months,

    Women will be divided into 3 different groups as a result of the points they get from PSST. The first group will consist of women who fully meet the PMDD criteria. These Women must have at least one of the four main symptom groups from the group A symptoms plus any of the 4 symptoms marked as moderate to severe on the instrument. In addition, he should have reported that at least one of the questions in group B was severe, and yes answers should be given to both questions in group C.The second group is the group that meets the PMS living criteria. These women are expected to have marked at least one of the 4 main symptoms as moderate to severe from the group A questions and any other 4 symptoms as moderate to severe to answer the group B questions as moderate to severe, and to answer yes to at least one question from the C group.The third group will be considered as the group with subthreshold symptoms consisting of those who do not meet the criteria for entering the other two groups.

Secondary outcomes

  1. Scale Of Interpersonal Relatıonshıps Dımensıons

    Time frame: Baseline (beginning), Change from Baseline Sub-dimensions of Interpersonal Relationships Scale after 2 months, Change from Baseline Sub-dimensions of Interpersonal Relationships Scale after 5 months

    The scale, which consists of 53 items in total, has 4 sub-dimensions. These are Confirmation, addiction, empathy, trust in others, and emotional awareness.

    The high score obtained from each sub-dimension of the scale indicates that the individual has more features evaluated by the relevant sub-dimension.

  2. Perceived stress scale

    Time frame: Baseline (beginning), 2 months after beginning, 3 months after beginning

    The higher the total score, the more negative it is.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect of Interpersonal Counseling in Symptoms Management of Premenstrual Syndrome

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2021
Registry last updated
Apr 9, 2021

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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