NCT06180343

Brief Summary

Anxiety is a mood that focuses on the future, related to being prepared for possible upcoming negative events (fear, pain or danger), and unlike fear, its object is not determined or recognized, and it is exposed to uncertainty. Art therapy is used in the clinical and rehabilitation field as a useful tool for self-expression, healing and well-being. The close relationship between art, healing and well-being, and the therapeutic power of art has long been accepted all over the world.Many studies have been conducted in the literature examining the effect of mandala painting on reducing anxiety.This proposed project was planned to be carried out as a quasi-experimental study, based on the idea that mandala painting can reduce the level of anxiety in students and have a positive effect on the quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable anxiety

Status
unknown

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 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 12, 2023

Last Update Submit

January 27, 2024

Conditions

Keywords

Mandala coloringStress

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form

    The form consists of questions about socio-demographic

    1 week

Secondary Outcomes (2)

  • World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF-TR)

    6 weeks

  • State-trait anxiety inventory

    6 weeks

Study Arms (2)

Mandala coloring group

EXPERIMENTAL

Participants will be asked to choose the pages they want from the 12 colored felt-tip pen paint sets and mandala coloring book given to each participant by the researcher, and color them in the colors they want, for 6 weeks, once a week, at any time of the day and for an average of 20-30 minutes each time. Participants will be asked to send a message before they start painting the mandala, and after the process, they will be asked to take a picture of the mandala they have painted and send it to the researcher. If the participants forget to color the mandala, a reminder message will be sent by the researcher twice a week.

Other: Mandala

Control group

NO INTERVENTION

Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms. Participants will be asked by telephone by the researcher twice a week for 6 weeks whether they have taken any action to reduce their anxiety symptoms. Participants who use any of the pharmacological or non-pharmacological practices to reduce anxiety symptoms will be excluded from the study.

Interventions

MandalaOTHER

Participants will be asked to choose the pages they want from the 12 colored felt-tip pen paint sets and mandala coloring book given to each participant by the researcher, and color them in the colors they want, for 6 weeks, once a week, at any time of the day and for an average of 20-30 minutes each time. Participants will be asked to send a message before they start painting the mandala, and after the process, they will be asked to take a picture of the mandala they have painted and send it to the researcher. If the participants forget to color the mandala, a reminder message will be sent by the researcher twice a week.

Mandala coloring group

Eligibility Criteria

Age19 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Continuing her education at the Midwifery Department of the Faculty of Health Sciences
  • Volunteering to participate in the study
  • Knowing Turkish (being literate)

You may not qualify if:

  • Having diagnosed psychiatric diseases,
  • STAI anxiety score ≤36 (non-anxious)
  • Having previously received non-pharmacological or pharmacological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • AYCA SOLT KIRCA, Phd

    Kırklareli University

    STUDY DIRECTOR

Central Study Contacts

AYCA SOLT KIRCA, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomize controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssociate professor

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 22, 2023

Study Start

January 30, 2024

Primary Completion

March 15, 2024

Study Completion

April 20, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share