The Effect of Painting Therapy in Children

December 30, 2024 updated by: Nilay Şahan, Çankırı Karatekin University

The Effect of Painting Therapy on Visual Perception, Hand Functions, Social Participation and Quality of Life in Children

This study was designed to examine the effect of picture supported art therapy on visual perception, hand functions, participation and quality of life of children in healthy children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is planned that at least 25 children in each group will participate in the study. For both the control group and the study group, the sample of the study will consist of children between the ages of 6-12 who do not have any known disease/disability and show typical development, who voluntarily agree to participate in our study and sign the consent form. In addition, children in the control group should not have participated in any art course.Sociodemographic information will be asked first in the evaluation of the individuals in the study. Then, which hand of the children is dominant will be determined with Edinburg Hand Preference Questionnaire. Visual perception of the children will be evaluated with the shape-ground subtest of the Ayres Southern California Sensory Integrity Test, hand skills will be evaluated with the 9-hole peg test and the sense of kinesthesia in their fingers will be evaluated with the kinesthesia subtest of the Ayres Southern California Sensory Integrity Test. Children's quality of life will be assessed with the Young Child Quality of Life Questionnaire in accordance with their age. The Child and Adolescent Participation Questionnaire will be given to the parents to question the social participation of the children and the Conners Parent Rating Scale will be given to the parents to evaluate the disruptive behaviour disorders. Initial assessments will be made both in the study group and in the control group.The children in the study group will receive painting and drawing-based art therapy for 4 weeks, 2 days a week for 1 hour. After 4 weeks, all evaluations will be repeated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The sample of the study for both the control group and the study group,
  • To be between 6-12 years old,
  • not having any known illness/disability
  • voluntarily agree to participate in our study
  • The children in the control group should not have participated in any art course.

Exclusion Criteria:

  • The sample of the study for both the control group and the study group,
  • Not to be between 6-12 years old
  • having any known illness/disability (such as neurological, mental illness)
  • not voluntarily agreeing to participate in our study
  • Children in the control group participated in any art course

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
The children in the control group should not have participated in any painting course.
Experimental: Art therapy group
The children in the art therapy group will receive painting and drawing-based painting therapy for 4 weeks, 2 days a week for 1 hour.
Other: Art therapy group
Application of different applications of art therapy such as painting, drawing, cutting to children

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children's age
Time Frame: Day 1 of the study will be evaluated.
age in year
Day 1 of the study will be evaluated.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Children's weight
Time Frame: Day 1 of the study will be evaluated.
weight in kilograms
Day 1 of the study will be evaluated.
Children's height
Time Frame: Day 1 of the study will be evaluated.
height in meters
Day 1 of the study will be evaluated.
Childern's body mass index (BMI)
Time Frame: Day 1 of the study will be evaluated.
weight and height will be combined to report BMI in kg/m2
Day 1 of the study will be evaluated.
Mothers' age
Time Frame: Day 1 of the study will be evaluated.
age in year
Day 1 of the study will be evaluated.
Mothers' education status
Time Frame: Day 1 of the study will be evaluated.
education status like primary school, high school, university, etc.
Day 1 of the study will be evaluated.
visual perception
Time Frame: From enrollment to the end of treatment at 4 weeks.
Children's visual perception will be assessed using the shape-ground subtest of the Ayres Southern California Sensory Integrity Test. Ayres Southern California Sensory Integrity Tests is a standardised and reliable test battery consisting of 17 subtests and can be used in both children and adults from the age of 4.
From enrollment to the end of treatment at 4 weeks.
Hand function
Time Frame: From enrollment to the end of treatment at 4 weeks.
Individuals' manual dexterity will be assessed with the 9-Hole Peg Test. It is a quick simple manual dexterity test that is particularly sensitive to changes in upper extremity performance. The test material consists of 9 small sticks made in standard sizes and a board with 9 holes on which they are placed. Individuals are asked to place the sticks one by one on the board as fast as possible and then remove them. Time is measured with a stopwatch. Measurement is performed for both extremities, first the right and then the left hand.
From enrollment to the end of treatment at 4 weeks.
Hand preference
Time Frame: From enrollment to the end of treatment at 4 weeks.
It is a frequently applied questionnaire to determine the dominant hand. It questions the hand or hands used in 10 activities of daily living such as writing, drawing, throwing, using scissors, using a toothbrush, using a knife without a fork, using a spoon, sweeping with a broom, lighting a match and opening a box. The scoring ranges from -100 (left hand) to +100 (right hand). The evaluation is calculated with the Geschwind Score (GS). In the scoring; those with a score of 80 to 100 are defined as strong right-handed, those with a score of 20 to 75 as weak right-handed, those with a score of -15 to 15 as mixed-handed, those with a score of -20 to -75 as weak left-handed and those with a score of -80 to -100 as strong left-handed.
From enrollment to the end of treatment at 4 weeks.
kinesthesia assessment
Time Frame: From enrollment to the end of treatment at 4 weeks.
Ayres Southern California Sensory Integrity Tests is a standardized and reliable test battery consisting of 17 subtests and can be used in both children and adults from the age of 4 years. It was developed by Anne Jean Ayres in 1979 to examine sensory processing skills for different conditions such as vestibular, proprioceptive, kinesthetic and tactile systems and to reveal inadequate function in the sensory processing process. In our study, the kinesthesia subtest of the Ayres Southern California Sensory Integrity Tests will be used.
From enrollment to the end of treatment at 4 weeks.
The Child and Adolescent Participation Questionnaire
Time Frame: From enrollment to the end of treatment at 4 weeks.
The Child and Adolescent Participation Questionnaire is a questionnaire used to assess social participation. The CASP scale assesses the child's participation in the home, school, neighborhood and community. It consists of a total of 20 questions and has 4 sub-sections. Home participation consists of 4 questions, school participation consists of 5 questions, neighborhood and community participation consists of 4 questions, and home and community activities consists of 5 questions. The participation questionnaire is completed by the child's family or carers. The evaluation is based on a total of 100 points. Low scores indicate a low level of participation; high scores indicate a good level of participation. Scoring is done between 0-4.
From enrollment to the end of treatment at 4 weeks.
Young Child Quality of Life Questionnaire
Time Frame: From enrollment to the end of treatment at 4 weeks.
The scale aims to measure the general quality of life in the 2-18 age group. The scale consists of a total of 23 questions including physical function 8 questions, emotional function 5 questions, social function 5 questions and school function 5 questions and was prepared for four different age groups.Firstly, the total scale score (TTS), secondly, the total physical health score (FSTP), and thirdly, the total psychosocial health score (PSTP), which consists of the calculation of item scores evaluating emotional, social and school functionality, are calculated. The items are scored between 0-100.The higher the total score of the scale, the better the health-related quality of life is perceived.
From enrollment to the end of treatment at 4 weeks.
Revised Conners Parent Rating Scale Short Turkish Form
Time Frame: From enrollment to the end of treatment at 4 weeks.
It is a scale used to screen 'Attention Deficit and Disruptive Behavior Disorders'. High scores obtained from the scale indicate the intensity of symptoms specific to destructive disorders.
From enrollment to the end of treatment at 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Çankırı Karatekin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nilay Şahan, PhD, Çankırı Karatekin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ae2036af3d594ea0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of this study will be available upon reasonable request but will not be publicly accessible due to privacy or confidentiality concerns.

IPD Sharing Time Frame

Immediately following publication.No end date.

IPD Sharing Access Criteria

Proposals should be directed to nilaysahan@karatekin.edu.tr.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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