NCT05665972

Brief Summary

This research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

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

First Submitted

Initial submission to the registry

December 16, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

December 16, 2022

Last Update Submit

July 16, 2024

Conditions

Keywords

Premenstrual syndromeMandala coloring

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form

    The form consists of questions about socio-demographic and menstrual periods.

    between one to six months

Secondary Outcomes (1)

  • Premenstrual Syndrome Scale

    between one to six months

Study Arms (2)

Mandala coloring group

EXPERIMENTAL

Mandala painting will be applied to women suffering from premenstrual syndrome.

Other: Mandala coloring

Control group

NO INTERVENTION

Participants in this group will consist of people who do not routinely do any practice on their own to reduce premenstrual syndrome symptoms.

Interventions

Each participant will be given 12 colored felt-tip pen paint sets and 12 mandala coloring pages by the researchers. Participants will be asked to dye for 3 menstrual cycles, 14 days before the start of menstruation, 1 day a week, at any time of the day and for an average of 20-30 minutes each time.

Mandala coloring group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the research
  • Fully answering survey and scale forms.
  • Ability to read and understand Turkish
  • Being between the ages of 18 and 30 years
  • Having regular menstruation (between 21 and 35 days)
  • Having 45 or more from PMSS

You may not qualify if:

  • Unwilling to continue working
  • Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
  • Having a gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.)
  • Having a chronic or physical illness
  • Having a mental illness
  • Being under psychiatric treatment (Pharmacotherapy or psychotherapy)
  • Taking medication for menopausal symptoms
  • Using one of the pharmacological or non-pharmacological methods to reduce premenstrual symptoms (COCs, acupressure, homeopathy, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırklareli University

Kırklareli, Centre, 39000, Turkey (Türkiye)

Location

Related Publications (1)

  • Derin E, Solt Kirca A. The Effect of Mandala Coloring on Premenstrual Syndrome: A Randomized Controlled Experimental Study. Holist Nurs Pract. 2025 Nov 3. doi: 10.1097/HNP.0000000000000724. Online ahead of print.

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Efsun DERİN

    Kırklareli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 27, 2022

Study Start

October 1, 2023

Primary Completion

June 11, 2024

Study Completion

June 11, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations