Premenstrual SyndromesNCT06585475
Investigation of the Effectiveness of Structured Education According to Premenstrual Syndrome Symptom Map
A study testing Structured training according to premenstrual syndrome symptom map in people with Premenstrual Syndromes and Education, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndromes, Education, Menstrual Cycle Disorder
- What is being tested?
- Structured training according to premenstrual syndrome symptom map
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 5 Aug 2024
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meeting ACOG's PMS diagnostic criteria Being over 18 years of age, Not using psychotherapeutic medications, Not having a mental illness, Not being pregnant, Agreeing to participate in the study
Who cannot join
- Not having regular menstruation in the last 3 months, Using analgesics during menstruation while participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Structured Training According to the Premenstrual Syndrome Symptom Map
In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Women who met the inclusion criteria and volunteered to participate in the study constituted the sample of the study. As a result of block randomisation, 55 women were assigned to the intervention group and 55 women to the control group. Pre-test data were collected from the women allocated to the intervention and control groups by means of data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, Premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). The intervention group received a 3-session structured training according to the PMS symptom map, while the control group did not receive any intervention. Women in the intervention group completed the post-test data on the last day of the 2nd cycle after the training, while women in the control group completed the post-test data on the last day of the 2nd cycle after the pre-test.
- Conditions
- Premenstrual Syndromes, Education, Menstrual Cycle Disorder
- Being tested
- Structured training according to premenstrual syndrome symptom map
- Keywords
- life satisfaction, pain, depression, stress, anxiety
- Medical subject headings
- Premenstrual Syndrome, Menstruation Disturbances, Personal Satisfaction, Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured training according to premenstrual syndrome symptom mapBehavioural
A symptom map consisting of evidence-based practices for coping with PMS symptoms was created. An educational content based on this map was prepared and applied to women with PMS to evaluate whether it was effective compared to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention group received a 3-session PMS symptom map-structured training by the responsible and first author (ADK). Before the training, pre-test data were collected using data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). After the training, post-test data were collected on the last day of the 1nd cycle. Receives: Behavioral: Structured training according to premenstrual syndrome symptom map |
| Control group | No intervention | No intervention was applied to the control group. After the participants were divided into groups by randomization, pre-test data were collected using data collection tools (VAS pain scoring, DAS depression stress anxiety rating scale, premenstrual syndrome rating scale and premenstrual syndrome specific life satisfaction scale). After the pre-test, post-test data were collected on the last day of the cycle after 1 menstrual cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual syndrome assessment scale
a scale used to measure the degree of premenstrual syndrome
Measured: pre-intervention, 2 month after intervention
premenstrual syndrome specific life satisfaction scale
Premenstrual syndrome specific life satisfaction scale evaluates life satisfaction of women with PMS
Measured: pre-intervention, 2 month after intervention
DAS depression stress anxiety assessment scale
DAS depression stress anxiety assessment scale, evaluates psychological symptoms
Measured: pre-intervention, 2 month after intervention
VAS pain score
1.421 / 5.000 VAS pain score measures pain score
Measured: pre-intervention, 2 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Nov 2023
- Primary completion10 Jun 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromesStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe 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
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585475
- Sponsor's protocol ID
- 23.08.2024
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demirhan Kayacik A, Ilcioglu K. Effectiveness of symptom map-based education in the management of premenstrual syndrome: a randomized controlled trial. Arch Womens Ment Health. 2026 Sep 15;29(5):119. doi: 10.1007/s00737-026-01757-4.
PubMed 42742795
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Structured Training According to the Premenstrual Syndrome Symptom Map
- ClinicalTrials.gov ID
- NCT06585475
- Acronym / sponsor ID
- 23.08.2024
- Conditions
- Premenstrual Syndromes, Education, Menstrual Cycle Disorder
- Keywords
- life satisfaction, pain, depression, stress, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 5 Sep 2024 (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.
In this study, it was aimed to evaluate the effectiveness of the training structured according to the PMS symptom map. This experimental (randomised-controlled) study was conducted with women of reproductive age with PMS. Women who met the inclusion criteria and volunteered to participate in the study constituted the sample of the study. As a result of block randomisation, 55 women were assigned to the intervention group and 55 women to the control group. Pre-test data were collected from the women allocated to the intervention and control groups by means of data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, Premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). The intervention group received a 3-session structured training according to the PMS symptom map, while the control group did not receive any intervention. Women in the intervention group completed the post-test data on the last day of the 2nd cycle after the training, while women in the control group completed the post-test data on the last day of the 2nd cycle after the pre-test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Structured training according to premenstrual syndrome symptom mapThe intervention group received a 3-session PMS symptom map-structured training by the responsible and first author (ADK). Before the training, pre-test data were collected using data collection tools (VAS pain scoring, DAS depression stress anxiety assessment scale, premenstrual syndrome assessment scale and premenstrual syndrome-specific life satisfaction scale). After the training, post-test data were collected on the last day of the 1nd cycle. |
| Control group | No intervention | –No intervention was applied to the control group. After the participants were divided into groups by randomization, pre-test data were collected using data collection tools (VAS pain scoring, DAS depression stress anxiety rating scale, premenstrual syndrome rating scale and premenstrual syndrome specific life satisfaction scale). After the pre-test, post-test data were collected on the last day of the cycle after 1 menstrual cycles. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Meeting ACOG's PMS diagnostic criteria Being over 18 years of age, Not using psychotherapeutic medications, Not having a mental illness, Not being pregnant, Agreeing to participate in the study
Key exclusion criteria (1 listed)
- Not having regular menstruation in the last 3 months, Using analgesics during menstruation while participating in the study.
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 |
|---|---|---|
| Structured training according to premenstrual syndrome symptom mapA symptom map consisting of evidence-based practices for coping with PMS symptoms was created. An educational content based on this map was prepared and applied to women with PMS to evaluate whether it was effective compared to the control group. | Behavioural | Experimental group |
Primary outcome
Premenstrual syndrome assessment scale
Time frame: pre-intervention, 2 month after intervention
a scale used to measure the degree of premenstrual syndrome
premenstrual syndrome specific life satisfaction scale
Time frame: pre-intervention, 2 month after intervention
Premenstrual syndrome specific life satisfaction scale evaluates life satisfaction of women with PMS
DAS depression stress anxiety assessment scale
Time frame: pre-intervention, 2 month after intervention
DAS depression stress anxiety assessment scale, evaluates psychological symptoms
VAS pain score
Time frame: pre-intervention, 2 month after intervention
1.421 / 5.000 VAS pain score measures pain score
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 5 Sep 2024.
- Derived from this study: PubMed 42742795Demirhan Kayacik A, Ilcioglu K. Effectiveness of symptom map-based education in the management of premenstrual syndrome: a randomized controlled trial. Arch Womens Ment Health. 2026 Sep 15;29(5):119. doi: 10.1007/s00737-026-01757-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured training according to premenstrual syndrome symptom map in people with Premenstrual Syndromes and Education, run by Sakarya University 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 1 inclusion and 1 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 5 Sep 2024. 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 syndrome assessment scale (time frame: pre-intervention, 2 month after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585475, which also lists 1 linked publication.
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 5 Sep 2024.