NCT05524272

Brief Summary

Purpose: This study was conducted to find out the effects of colour by number mandala in decreasing the stress of hospitalized children with chronic disease. Design: A randomized controlled study. Methods: This study was conducted with 120 children between the ages of 8 and 11. 60 children formed the experimental group, while 60 children formed the control group. Descriptive Information Form and Perceived Stress Scale were used in data collection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

29 days

First QC Date

February 14, 2022

Last Update Submit

August 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • this study was measured colour-by-number mandalas do reduce the perceived stress levels in children hospitalised due to a chronic disease.

    A different colour-by-number mandala was given to each participant every day; the mean length of hospital stay was 3 days. At the end of the third day, the same researcher interviewed the children and filled out again the Perceived Stress Scale for Children. The Perceived Stress Scale for Children: A minimum of 0 and a maximum of 27 points are obtained from the scale. A high score from the scale indicates a high level of stress.

    3 days

Study Arms (1)

THE EFFECTS OF COLOUR BY NUMBER MANDALA

EXPERIMENTAL

This study was conducted to find out the effects of colour by number mandala in decreasing the stress of hospitalized children with chronic disease. A randomized controlled study.This study was conducted with 120 children between the ages of 8 and 11. 60 children formed the experimental group, while 60 children formed the control group. Descriptive Information Form and Perceived Stress Scale were used in data collection.

Other: This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease.

Interventions

Colour by number Mandala in different sizes includes pictures and numbers. The child has to find the colour specified in the number and colour it with the specified colour. Colourful pictures emerge as a result of colouring

THE EFFECTS OF COLOUR BY NUMBER MANDALA

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • parents who agreed to participate in the study

You may not qualify if:

  • visually impaired child
  • mentally retarded child
  • speech impaired children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat University

Elâzığ, Campus, 23000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2022

First Posted

September 1, 2022

Study Start

June 1, 2021

Primary Completion

June 30, 2021

Study Completion

January 28, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations