Premenstrual Syndrome and Interpersonal Counseling

• Sponsor: Istanbul University-Cerrahpasa (Other)
• Overall Status: Completed
• CT.gov ID: NCT04838691
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Premenstrual Syndrome	Behavioral: interpersonal counseling	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Interpersonal Counseling in Symptoms Management of Premenstrual Syndrome
• Actual Study Start Date: Apr 6, 2020
• Actual Primary Completion Date: May 6, 2020
• Actual Study Completion Date: Aug 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Premenstrual Symptom Screening Tool [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 Outcome Measures

1. 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]

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University-Cerrahpasa	Istanbul		Turkey

Sponsors and Collaborators

• Istanbul University-Cerrahpasa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zeynep Seyyide Bozkurt, Principle Investigator, Istanbul University-Cerrahpasa
• ClinicalTrials.gov Identifier: NCT04838691
• Other Study ID Numbers: zeynep
• First Posted: Apr 9, 2021
• Last Update Posted: Apr 9, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zeynep Seyyide Bozkurt, Principle Investigator, Istanbul University-Cerrahpasa: premenstrual syndrome; interpersonal counseling
• Additional relevant MeSH terms: Syndrome; Premenstrual Syndrome

Study Results

No Results Posted as of Apr 9, 2021