NCT05811130

Brief Summary

Our research aimed to investigate how a sedentary lifestyle, body mass index, depression, and stress affect the severity of PMS symptoms and how the listed factors influence each other.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

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 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

March 14, 2023

Last Update Submit

April 12, 2023

Conditions

Premenstrual Syndrome

Keywords

physical activityperceived stressmental health

Outcome Measures

Primary Outcomes (1)

  • Premenstrual syndrome

    * points; * Premenstrual Assessment Form Short Form Questionnaire (10 item version); * 1-6 point scale, * minimum score: 10 points; * maximum score: 60 points, * the higher the points the worse the symptoms

    1 day

Secondary Outcomes (4)

  • Physical activity

    1 day

  • Perceived Stress

    1 day

  • Mental Health

    1 day

  • BMI

    1 day

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women between the ages of 18-45 who reported symptoms of PMS during the period of parameterization of the target group

You may qualify if:

  • women
  • between the ages of 18-45 years
  • regular menstruation

You may not qualify if:

  • older than 45 years
  • pregnancy
  • amenorrhoea
  • premature ovarian failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pécs

Pécs, Baranya, 7621, Hungary

Location

MeSH Terms

Conditions

Premenstrual SyndromeMotor ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Olívia Dózsa-Juhász, BSc

    University of Pecs

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 13, 2023

Study Start

June 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

HU(1)