Premenstrual SyndromeNCT04838691
Premenstrual Syndrome and Interpersonal Counseling
A study testing interpersonal counseling in people with Premenstrual Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aims to test the effectiveness of interpersonal counseling in PMS symptom management in university students experiencing PMS symptoms. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- interpersonal counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2020to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Premenstrual Syndrome
- Being tested
- interpersonal counseling
- Keywords
- premenstrual syndrome, interpersonal counseling
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interpersonal counselingBehavioural
In the intervention group, it will be administered for 40 minutes for 8 weeks to people with symptoms of premenstrual syndrome.
| Study group | Role | What they receive |
|---|---|---|
| interpersonal relations counseling applied | Experimental | 8 sessions of interpersonal relations counseling, each lasting 40 minutes, were applied for 2. Receives: Behavioral: interpersonal counseling |
| no application | No intervention | No action taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: Baseline (beginning), 2 months after beginning, 3 months after beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start6 Apr 2020
- Primary completion6 May 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Seyyide Bozkurt, Istanbul University - Cerrahpasa
- Investigators
- Neslihan Özcan, Professor, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838691
- Sponsor's protocol ID
- zeynep
- Status last verified
- Apr 2021
- First submitted
- 3 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing is considered inappropriate before the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interpersonal Counseling in Symptoms Management of Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT04838691
- Acronym / sponsor ID
- zeynep
- Conditions
- Premenstrual Syndrome
- Keywords
- premenstrual syndrome, interpersonal counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interpersonal relations counseling applied | Experimental | Behavioral: interpersonal counseling8 sessions of interpersonal relations counseling, each lasting 40 minutes, were applied for 2. |
| no application | No intervention | –No action taken. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interpersonal counselingIn the intervention group, it will be administered for 40 minutes for 8 weeks to people with symptoms of premenstrual syndrome. | Behavioural | interpersonal relations counseling applied |
Primary outcome
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.
2 secondary outcomes
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
Perceived stress scale
Time frame: Baseline (beginning), 2 months after beginning, 3 months after beginning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No. Sharing is considered inappropriate before the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neslihan Özcan, Professor study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interpersonal counseling in people with Premenstrual Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.