Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
Primary Purpose
Child, Only, Chronic Diseases in Children
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease.
Sponsored by
About this trial
This is an interventional supportive care trial for Child, Only
Eligibility Criteria
Inclusion Criteria:
- parents who agreed to participate in the study
Exclusion Criteria:
- visually impaired child
- mentally retarded child
- speech impaired children
Sites / Locations
- Fırat University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
THE EFFECTS OF COLOUR BY NUMBER MANDALA
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05524272
Brief Title
Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
Official Title
Stress-Relieving Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
January 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Firat University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Experimental group: The children, along with their parents, were interviewed by one of the researchers on their first day of hospitalisation. The parents were informed about the Descriptive Information Form and the Perceived Stress Scale for Children, which the researcher filled out in the presence of the children and their parents. The children were then given a colour-by-number mandala and colouring pencils. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Only, Chronic Diseases in Children
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THE EFFECTS OF COLOUR BY NUMBER MANDALA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease.
Intervention Description
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
Primary Outcome Measure Information:
Title
this study was measured colour-by-number mandalas do reduce the perceived stress levels in children hospitalised due to a chronic disease.
Description
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.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
parents who agreed to participate in the study
Exclusion Criteria:
visually impaired child
mentally retarded child
speech impaired children
Facility Information:
Facility Name
Fırat University
City
Elazığ
State/Province
Campus
ZIP/Postal Code
23000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
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