Child, OnlyNCT05524272
Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
A study testing This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease. in people with Child, Only and Chronic Diseases in Children, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Child, Only, Chronic Diseases in Children
- What is being tested?
- This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 28 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parents who agreed to participate in the study
Who cannot join
- visually impaired child
- mentally retarded child
- speech impaired children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress-Relieving Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
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.
Read the 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.
- Conditions
- Child, Only, Chronic Diseases in Children
- Being tested
- This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease.Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Jun 2021
- Primary completion30 Jun 2021
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİDEM COŞKUN ŞİMŞEK, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524272
- Sponsor's protocol ID
- Colour-By-Number Mandalas
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-Relieving Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease
- ClinicalTrials.gov ID
- NCT05524272
- Acronym / sponsor ID
- Colour-By-Number Mandalas
- Conditions
- Child, Only, Chronic Diseases in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THE EFFECTS OF COLOUR BY NUMBER MANDALA | Experimental | 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.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. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- parents who agreed to participate in the study
Key exclusion criteria (3 listed)
- visually impaired child
- mentally retarded child
- speech impaired children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease.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 | Other | THE EFFECTS OF COLOUR BY NUMBER MANDALA |
Primary outcome
this study was measured colour-by-number mandalas do reduce the perceived stress levels in children hospitalised due to a chronic disease.
Time frame: 3 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Child, Only
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
Myopia, Myopia Progression
RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
High Grade Glioma, CNS Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing This study aims to evaluate the effects of colour by number mandala in decreasing the stress of children hospitalized due to their chronic disease. in people with Child, Only and Chronic Diseases in Children, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
this study was measured colour-by-number mandalas do reduce the perceived stress levels in children hospitalised due to a chronic disease. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.