NCT07684638

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

19 days

First QC Date

June 29, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

Premenstrual SyndromeQuality of lifeSelf Compassion

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Within approximately 1 week after baseline

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Ataşehir, Turkey (Türkiye)

Location

Related Publications (6)

  • Neff, K. D. (2003). Development and validation of a scale to measure self- compassion. Self and Identity, 2(3), 223-250.

    BACKGROUND
  • 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.

    PMID: 35113436BACKGROUND
  • Victor 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.

    PMID: 31181584BACKGROUND
  • American College of Obstetricians and Gynecologists. (2023). Premenstrual syndrome (PMS). https://www.acog.org/womens-health/faqs/premenstrual-syndrome

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 41680718BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Principal Investigator

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 6, 2026

Study Start

June 26, 2026

Primary Completion

July 15, 2026

Study Completion

July 15, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data will be available upon reasonable request to the corresponding investigator.

Locations