Premenstrual Syndrome and Interpersonal Counseling

April 8, 2021 updated by: Zeynep Seyyide Bozkurt, Istanbul University-Cerrahpasa

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University-Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (beginning), Change from Baseline PMDD or PMS after 2 months, Change from Baseline PMDD or PMS after 5 months,

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Baseline (beginning), 2 months after beginning, 3 months after beginning
The higher the total score, the more negative it is.
Baseline (beginning), 2 months after beginning, 3 months after beginning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University-Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Neslihan Özcan, Professor, Istanbul University-Cerrahpaşa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings