The Effect of Technology-Based Cognitive and Artistic Therapeutic Activities on the Mental Status of Children With Cancer

March 28, 2023 updated by: Çiğdem Sarı Öztürk, Gazi University

Technology-Based Cognitive and Artistic Therapeutic Activities

This research will be carried out to determine the effects of technology-based cognitive and artistic therapeutic activities on the mental state of children receiving cancer treatment. The research will be conducted in a single-blind parallel group randomized controlled trial design. A program consisting of six two-week sessions will be implemented. The program will include many artistic activities such as therapeutic and drawing.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In the study, a program consisting of technology-based cognitive and artistic activities will be applied to children followed up with cancer diagnosis. Therapeutic and artistic activities within the program (drawing, mandala, etc.). The program will be implemented in 6 sessions in two weeks. At the beginning and end of the program, children's anxiety and spiritual well-being levels will be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • 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 Locations

  • Turkey
      • Ankara, Turkey, 06560
        • Gazi University

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between the ages of 9-18,
  • Those receiving cancer treatment,
  • At least two months have passed since the start of treatment,
  • Those who have internet access on their smartphone or computer

Exclusion Criteria:

  • Those who have experienced an important life event other than illness (parents' divorce, death, moving, etc.) in the last six months,
  • Those who have not received chemotherapy treatment,
  • In the terminal period,
  • Children with a severe psychological diagnosis

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: technology-based cognitive and artistic therapeutic activities
The group receiving technology-based cognitive and artistic therapeutic activities
Behavioral: Technology-based cognitive and artistic therapeutic activities
Therapeutic and artistic activities within the program (drawing, mandala, etc.). The program will be implemented in 6 sessions in two weeks. At the beginning and end of the program, children's anxiety and spiritual well-being levels will be evaluated.
No Intervention: Control group
the group that did not receive any training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spielberger State-Trait Anxiety Inventory for children
Time Frame: Change from Baseline level of Spielberger State-Trait Anxiety to 2 weeks (change is being assessed)
The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score obtained from the scale varies between 20 and 60. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Change from Baseline level of Spielberger State-Trait Anxiety to 2 weeks (change is being assessed)
Adolescent Spiritual Well-Being Scale
Time Frame: Change from Baseline level of Adolescent Spiritual Well-Being Scale to 2 weeks (change is being assessed)
The scale is a 34-item self-report measure of anxiety using a 5-point Likert-type scale (from 0 to 3 points). The total score obtained from the scale varies between 0 and 100. The higher the score obtained from the scale, the better the spiritual well-being is determined.
Change from Baseline level of Adolescent Spiritual Well-Being Scale to 2 weeks (change is being assessed)

Collaborators and Investigators

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

Sponsor

Gazi 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 (Actual)

March 13, 2023

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

July 30, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSOZTURK-15/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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