Back to resultsPremenstrual Syndrome and Interpersonal Counseling
Primary Purpose
Premenstrual Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
interpersonal counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring premenstrual syndrome, interpersonal counseling
Eligibility Criteria
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
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
interpersonal relations counseling applied
no application
Arm Description
8 sessions of interpersonal relations counseling, each lasting 40 minutes, were applied for 2.
No action taken.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Perceived stress scale
The higher the total score, the more negative it is.
Full Information
NCT ID
NCT04838691
First Posted
April 3, 2021
Last Updated
April 8, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT04838691
Brief Title
Premenstrual Syndrome and Interpersonal Counseling
Official Title
The Effect of Interpersonal Counseling in Symptoms Management of Premenstrual Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2020 (Actual)
Primary Completion Date
May 6, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to test the effectiveness of interpersonal counseling in PMS symptom management in university students experiencing PMS symptoms.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
premenstrual syndrome, interpersonal counseling
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interpersonal relations counseling applied
Arm Type
Experimental
Arm Description
8 sessions of interpersonal relations counseling, each lasting 40 minutes, were applied for 2.
Arm Title
no application
Arm Type
No Intervention
Arm Description
No action taken.
Intervention Type
Behavioral
Intervention Name(s)
interpersonal counseling
Intervention Description
In the intervention group, it will be administered for 40 minutes for 8 weeks to people with symptoms of premenstrual syndrome.
Primary Outcome Measure Information:
Title
Premenstrual Symptom Screening Tool
Description
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.
Time Frame
Baseline (beginning), Change from Baseline PMDD or PMS after 2 months, Change from Baseline PMDD or PMS after 5 months,
Secondary Outcome Measure Information:
Title
Scale Of Interpersonal Relatıonshıps Dımensıons
Description
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.
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
Title
Perceived stress scale
Description
The higher the total score, the more negative it is.
Time Frame
Baseline (beginning), 2 months after beginning, 3 months after beginning
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neslihan Özcan, Professor
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Sharing is considered inappropriate before the end of the study.
Learn more about this trial
Premenstrual Syndrome and Interpersonal Counseling
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