NCT05144568

Brief Summary

The aim of our study is to examine the effect of nutritional education given to university students with premenstrual syndrome (PMS) on premenstrual symptom severity, nutrient intake and anthropometric measures. Our hypothesis is that nutrition education reduces symptoms in students with PMS. The effect of nutrition education on premenstrual syndrome was evaluated. The sample for this study included 83 female students, with 43 in the experimental and 40 in the control group, who were studying at the health sciences faculty of a state university and met the inclusion criteria. Experimental and control groups were formed by randomized method. Nutrition training was given to the experimental group. Participant data were collected before and four months after nutrition training. The data were collected with the personal information form, Premenstrual Syndrome Scale and food consumption record form. Nutrient amounts were determined in the Nutrition Information System (BEBİS) program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

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 3, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

October 18, 2021

Last Update Submit

November 22, 2021

Conditions

Keywords

premenstrual syndromenutritional statusnutrition educationnursing studentsuniversity students

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of the nutrition education given to the experimental group was evaluated with the Premenstrual Syndrome Scale.

    The Premenstrual Syndrome Scale consists of 44 questions. The PMSS is Likert type and its items are scored between 1 and 5 points. Lowest points of 44 and highest points of 220 can be obtained on the PMSS. The scale has a total of 9 subscales: depressive feeling, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, changes in sleeping habits and swelling. A higher score on the scale indicates that the severity of premenstrual syndrome is high. When the score of the total PMSS and subscales is higher than 50% of the total score, it is considered to indicate PMS.

    3 months

Study Arms (2)

experimental group

EXPERIMENTAL

Nutrition education will be given to participants with PMS in the experimental group.

Other: Nutrition education

Control group

NO INTERVENTION

Interventions

Nutrition education will be given to improve PMS

experimental group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is a study only on women with menstrual cycles. It is a study aimed at reducing the symptoms seen before the menstrual cycle. Therefore, the study was conducted with female participants.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer to participate in the study
  • be woman
  • have a regular menstrual cycle
  • be 18 years or older

You may not qualify if:

  • have a chronic illness
  • have been on a diet in the last 3 months
  • using oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

October 18, 2021

First Posted

December 3, 2021

Study Start

June 3, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

December 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations