Premenstrual Syndrome and Interpersonal Counseling

NCT04838691 | Completed

• 1 other identifier: zeynep
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Premenstrual Syndrome

Keywords

premenstrual syndrome; interpersonal counseling

Outcome Measures

Primary Outcomes (1)

• Premenstrual Symptom Screening Tool

  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.

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

Secondary Outcomes (2)

• Scale Of Interpersonal Relatıonshıps Dımensıons

  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

• Perceived stress scale

  Baseline (beginning), 2 months after beginning, 3 months after beginning

Study Arms (2)

interpersonal relations counseling applied

EXPERIMENTAL

8 sessions of interpersonal relations counseling, each lasting 40 minutes, were applied for 2.

Behavioral: interpersonal counseling

no application

NO INTERVENTION

No action taken.

Interventions

interpersonal counseling BEHAVIORAL

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

interpersonal relations counseling applied

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neslihan Özcan, Professor

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 9, 2021
• Study Start: April 6, 2020
• Primary Completion: May 6, 2020
• Study Completion: August 30, 2020
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)