NCT05428813

Brief Summary

This study will be conducted to determine the effect of art therapy techniques on premenstrual syndrome symptoms.The study is a randomized controlled type study. The study will be conducted with 70 female students with premenstrual syndrome. In the study, which consists of two groups, experimental (n=35) and control (n=35), art therapy techniques will be applied to the students in the experimental group for 8 weeks. The control group will continue their routine coping habits. Both groups will be evaluated with the Premenstrual Syndrome scale at the end of the study, and the difference between the groups will be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

June 9, 2022

Last Update Submit

February 14, 2023

Conditions

Keywords

Premenstrual Syndrome, Art, Women Health

Outcome Measures

Primary Outcomes (1)

  • Techniques to be applied in the experimental group

    At the end of 8 weeks, improvement in premenstrual syndrome symptoms is expected in the experimental group.

    It includes an 8-week process.

Study Arms (2)

Experimental

EXPERIMENTAL

The group to which art therapy techniques will be applied.

Behavioral: art therapy techniques

Control

NO INTERVENTION

The group that will continue their routine coping habits related to premenstrual syndrome.

Interventions

Art therapy is a method that allows individuals to increase their self-awareness and realize their emotions better through artistic techniques.

Experimental

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study will be conducted with female students with premenstrual syndrome.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being over 18 years old,
  • Willing and volunteering to work,
  • Being able to read and write and understand what one reads,
  • Getting a score of 110 and above in PMSS

You may not qualify if:

  • Engaging in any artistic activity,
  • Having experienced changes in the menstrual cycle in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Tuğçe ÇİTİL, PhD

    Kütahya Health Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 23, 2022

Study Start

April 15, 2022

Primary Completion

September 15, 2022

Study Completion

December 30, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations