Premenstrual Syndrome and Interpersonal Counseling

The Effect of Interpersonal Counseling in Symptoms Management of Premenstrual Syndrome

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

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Behavioral: interpersonal counseling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interpersonal relations counseling applied; 8 sessions of interpersonal relations counseling, each lasting 40 minutes, were applied for 2.	Behavioral: interpersonal counseling; In the intervention group, it will be administered for 40 minutes for 8 weeks to people with symptoms of premenstrual syndrome.
No Intervention: no application; No action taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale Of Interpersonal Relatıonshıps Dımensıons	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.	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	The higher the total score, the more negative it is.	Baseline (beginning), 2 months after beginning, 3 months after beginning

Collaborators and Investigators

• Sponsor: Istanbul University-Cerrahpasa
• Investigators: Study Director: Neslihan Özcan, Professor, Istanbul University-Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Actual): May 6, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: April 3, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: premenstrual syndrome; interpersonal counseling
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: Zeynep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Sharing is considered inappropriate before the end of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No