Premenstrual SyndromeNCT07684638
Self-Compassion and Quality of Life in Nursing Students With Premenstrual Syndrome
An observational study of Premenstrual Syndrome and Quality of Life, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Premenstrual syndrome (PMS) is one of the most common menstrual disorders among women of reproductive age and is characterized by recurrent physical, emotional, cognitive, and behavioral symptoms during the late luteal phase of the menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Quality of Life, Self Compassion
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2026to 15 Jul 2026
- Phase
- Observational
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female undergraduate nursing students aged 18-25 years with premenstrual syndrome, defined as a Premenstrual Syndrome Scale (PMSS) score of 110 or higher, who meet the study eligibility criteria.
Who may be able to join
- Female nursing students aged 18 to 25 years.
- Regular menstrual cycles.
- Premenstrual Syndrome Scale (PMSS) total score of 110 or higher, indicating premenstrual syndrome according to the established cut-off value.
- Willingness to participate and provide written informed consent.
Who cannot join
- Receiving ongoing physician-prescribed pharmacological treatment for premenstrual syndrome (e.g., oral contraceptives, hormonal therapy, or selective serotonin reuptake inhibitors).
- Irregular menstrual cycles.
- History of chronic medical disease.
- History of psychiatric disorders.
- Incomplete study questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Mediating Role of Self-Compassion in the Association Between Premenstrual Symptom Severity and Premenstrual Syndrome-Specific Quality of Life Among Nursing Students With Premenstrual Syndrome
Premenstrual syndrome (PMS) is one of the most common menstrual disorders among women of reproductive age and is characterized by recurrent physical, emotional, cognitive, and behavioral symptoms during the late luteal phase of the menstrual cycle. These symptoms may adversely affect academic performance, daily functioning, interpersonal relationships, and quality of life. Although previous studies have demonstrated that greater premenstrual symptom severity is associated with poorer quality of life, the psychological mechanisms underlying this relationship remain unclear. Self-compassion, defined as a compassionate and nonjudgmental attitude toward oneself during times of difficulty, has been identified as a protective psychological factor associated with better emotional well-being and adaptive coping. However, its mediating role in the relationship between premenstrual symptom severity and premenstrual syndrome-specific quality of life has not been adequately investigated. This cross-sectional study aims to examine the association between premenstrual symptom severity and premenstrual syndrome-specific quality of life and to investigate the mediating role of self-compassion among nursing students who meet the study criteria for PMS (Premenstrual Syndrome Scale score ≥110).
- Conditions
- Premenstrual Syndrome, Quality of Life, Self Compassion
- Keywords
- Premenstrual Syndrome, Quality of life, Self Compassion
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Students Meeting the Study Criteria for PMS | Female nursing students aged 18-25 years with Premenstrual Syndrome Scale (PMSS) scores ≥110 who meet the study eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic, Menstrual, and Lifestyle Characteristics
Sociodemographic, menstrual, reproductive, and lifestyle characteristics will be collected using a researcher-developed questionnaire consisting of 20 items. The questionnaire includes information on age, academic year, menstrual history, menstrual pain characteristics, premenstrual syndrome history, analgesic use, sleep characteristics, caffeine consumption, fast-food consumption, sugar intake, and other lifestyle-related factors.
Measured: Baseline
Premenstrual Syndrome Scale (PMSS)
Premenstrual symptom severity will be assessed using the Premenstrual Syndrome Scale (PMSS). The PMSS is a 44-item self-report instrument consisting of nine subscales (depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating). Total scores range from 44 to 220, with higher scores indicating greater premenstrual symptom severity. In accordance with the original scale, a total PMSS score of 110 or higher, representing the established cut-off for premenstrual syndrome, will be used as an eligibility criterion for study enrollment.
Measured: Baseline
Premenstrual Syndrome-Specific Quality of Life Scale (PMS-QoL)
Premenstrual syndrome-specific quality of life will be assessed using the Premenstrual Syndrome-Specific Quality of Life Scale (PMS-QoL). The PMS-QoL is a 22-item self-report instrument consisting of three domains: physical well-being, emotional well-being, and social well-being. Higher scores indicate better premenstrual syndrome-specific quality of life.
Measured: Within approximately 1 week after baseline
Self-Compassion Scale (SCS)
Self-compassion will be assessed using the Self-Compassion Scale (SCS). The SCS is a 26-item self-report instrument comprising six dimensions: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Higher scores indicate greater self-compassion.
Measured: Within approximately 1 week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start26 Jun 2026
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Acibadem 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Ünlü Suvari, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684638
- Sponsor's protocol ID
- 2026-11/131
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will be available upon reasonable request to the corresponding investigator.
Publications
Neff, K. D. (2003). Development and validation of a scale to measure self- compassion. Self and Identity, 2(3), 223-250.
Branecka-Wozniak D, Cymbaluk-Ploska A, Kurzawa R. The impact of premenstrual syndrome on women's quality of life - a myth or a fact? Eur Rev Med Pharmacol Sci. 2022 Jan;26(2):598-609. doi: 10.26355/eurrev_202201_27887.
PubMed 35113436Victor FF, Souza AI, Barreiros CDT, Barros JLN, Silva FACD, Ferreira ALCG. Quality of Life among University Students with Premenstrual Syndrome. Rev Bras Ginecol Obstet. 2019 May;41(5):312-317. doi: 10.1055/s-0039-1688709. Epub 2019 Jun 10.
PubMed 31181584American College of Obstetricians and Gynecologists. (2023). Premenstrual syndrome (PMS). https://www.acog.org/womens-health/faqs/premenstrual-syndrome
Guldu, E. T. C., & Canbay, F. C. (2025). Prevalence and risk factors of premenstrual syndrome in Turkey: A systematic review and meta-analysis. International Journal of Caring Sciences, 18(1), 190.
Celik B, Tektas P. Self-compassion and premenstrual syndrome symptoms in women: a descriptive correlational study. BMC Womens Health. 2026 Feb 12;26(1):166. doi: 10.1186/s12905-026-04338-w.
PubMed 41680718
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Role of Self-Compassion in the Association Between Premenstrual Symptom Severity and Premenstrual Syndrome-Specific Quality of Life Among Nursing Students With Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT07684638
- Acronym / sponsor ID
- 2026-11/131
- Conditions
- Premenstrual Syndrome, Quality of Life, Self Compassion
- Keywords
- Premenstrual Syndrome, Quality of life, Self Compassion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 6 Jul 2026 (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.
Premenstrual syndrome (PMS) is one of the most common menstrual disorders among women of reproductive age and is characterized by recurrent physical, emotional, cognitive, and behavioral symptoms during the late luteal phase of the menstrual cycle. These symptoms may adversely affect academic performance, daily functioning, interpersonal relationships, and quality of life. Although previous studies have demonstrated that greater premenstrual symptom severity is associated with poorer quality of life, the psychological mechanisms underlying this relationship remain unclear. Self-compassion, defined as a compassionate and nonjudgmental attitude toward oneself during times of difficulty, has been identified as a protective psychological factor associated with better emotional well-being and adaptive coping. However, its mediating role in the relationship between premenstrual symptom severity and premenstrual syndrome-specific quality of life has not been adequately investigated. This cross-sectional study aims to examine the association between premenstrual symptom severity and premenstrual syndrome-specific quality of life and to investigate the mediating role of self-compassion among nursing students who meet the study criteria for PMS (Premenstrual Syndrome Scale score ≥110).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing Students Meeting the Study Criteria for PMS | – | –Female nursing students aged 18-25 years with Premenstrual Syndrome Scale (PMSS) scores ≥110 who meet the study eligibility criteria. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female undergraduate nursing students aged 18-25 years with premenstrual syndrome, defined as a Premenstrual Syndrome Scale (PMSS) score of 110 or higher, who meet the study eligibility criteria.
Key inclusion criteria (4 listed)
- Female nursing students aged 18 to 25 years.
- Regular menstrual cycles.
- Premenstrual Syndrome Scale (PMSS) total score of 110 or higher, indicating premenstrual syndrome according to the established cut-off value.
- Willingness to participate and provide written informed consent.
Key exclusion criteria (5 listed)
- Receiving ongoing physician-prescribed pharmacological treatment for premenstrual syndrome (e.g., oral contraceptives, hormonal therapy, or selective serotonin reuptake inhibitors).
- Irregular menstrual cycles.
- History of chronic medical disease.
- History of psychiatric disorders.
- Incomplete study questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sociodemographic, Menstrual, and Lifestyle Characteristics
Time frame: Baseline
Sociodemographic, menstrual, reproductive, and lifestyle characteristics will be collected using a researcher-developed questionnaire consisting of 20 items. The questionnaire includes information on age, academic year, menstrual history, menstrual pain characteristics, premenstrual syndrome history, analgesic use, sleep characteristics, caffeine consumption, fast-food consumption, sugar intake, and other lifestyle-related factors.
Premenstrual Syndrome Scale (PMSS)
Time frame: Baseline
Premenstrual symptom severity will be assessed using the Premenstrual Syndrome Scale (PMSS). The PMSS is a 44-item self-report instrument consisting of nine subscales (depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating). Total scores range from 44 to 220, with higher scores indicating greater premenstrual symptom severity. In accordance with the original scale, a total PMSS score of 110 or higher, representing the established cut-off for premenstrual syndrome, will be used as an eligibility criterion for study enrollment.
Premenstrual Syndrome-Specific Quality of Life Scale (PMS-QoL)
Time frame: Within approximately 1 week after baseline
Premenstrual syndrome-specific quality of life will be assessed using the Premenstrual Syndrome-Specific Quality of Life Scale (PMS-QoL). The PMS-QoL is a 22-item self-report instrument consisting of three domains: physical well-being, emotional well-being, and social well-being. Higher scores indicate better premenstrual syndrome-specific quality of life.
Self-Compassion Scale (SCS)
Time frame: Within approximately 1 week after baseline
Self-compassion will be assessed using the Self-Compassion Scale (SCS). The SCS is a 26-item self-report instrument comprising six dimensions: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Higher scores indicate greater self-compassion.
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 21 Jul 2026.
- BackgroundNeff, K. D. (2003). Development and validation of a scale to measure self- compassion. Self and Identity, 2(3), 223-250.
- Background: PubMed 35113436Branecka-Wozniak D, Cymbaluk-Ploska A, Kurzawa R. The impact of premenstrual syndrome on women's quality of life - a myth or a fact? Eur Rev Med Pharmacol Sci. 2022 Jan;26(2):598-609. doi: 10.26355/eurrev_202201_27887.
- Background: PubMed 31181584Victor FF, Souza AI, Barreiros CDT, Barros JLN, Silva FACD, Ferreira ALCG. Quality of Life among University Students with Premenstrual Syndrome. Rev Bras Ginecol Obstet. 2019 May;41(5):312-317. doi: 10.1055/s-0039-1688709. Epub 2019 Jun 10.
- BackgroundAmerican College of Obstetricians and Gynecologists. (2023). Premenstrual syndrome (PMS). https://www.acog.org/womens-health/faqs/premenstrual-syndrome
- BackgroundGuldu, E. T. C., & Canbay, F. C. (2025). Prevalence and risk factors of premenstrual syndrome in Turkey: A systematic review and meta-analysis. International Journal of Caring Sciences, 18(1), 190.
- Background: PubMed 41680718Celik B, Tektas P. Self-compassion and premenstrual syndrome symptoms in women: a descriptive correlational study. BMC Womens Health. 2026 Feb 12;26(1):166. doi: 10.1186/s12905-026-04338-w.
- Individual participant dataSharing planned: No. De-identified individual participant data will be available upon reasonable request to the corresponding investigator.
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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?
An observational study of Premenstrual Syndrome and Quality of Life, run by Acibadem 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 4 inclusion and 5 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 21 Jul 2026. 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?
Sociodemographic, Menstrual, and Lifestyle Characteristics (time frame: Baseline). 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 NCT07684638, which also lists 6 linked publications.
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 21 Jul 2026.