Effects of Therapeutic Artistic Activities on the Mental Status of Adolescents Followed Up with Diabetes Diagnosis

Therapeutic Artistic Activities in Adolescent with Diabetes

This study will examine the effectiveness of therapeutic artistic activities in diabetic adolescents between the ages of 9-18. The study includes a 6-week program. The program will use art activities that can affect well-being, such as drawing a picture called a mandala. The State Anxiety Inventory will be used to measure the anxiety levels of adolescents, the Psychological Well-being Scale to assess their well-being, and a process evaluation form to evaluate the program (such as satisfaction).

Study Overview

• Status: Enrolling by invitation
• Conditions: Adolescent; Diabetes
• Intervention / Treatment: Behavioral: Therapeutic Intervention

Detailed Description

This study will be conducted with adolescents between the ages of 9-18 who are diagnosed with Type 1 Diabetes. The study includes a 6-week program. Art activities that can affect well-being, such as drawing a picture called a mandala, will be used in the program. Mandala drawing and painting will be done with the adolescents in the second and fourth weeks of the study. The drawings will be discussed in the third and fifth weeks. A common storytelling technique will be used according to the adolescents; feelings about drawing and painting. In the study, the State Anxiety Inventory will be used to measure the anxiety levels of the adolescents, the Psychological Well-being Scale to evaluate their well-being, and the process evaluation form where they evaluate the program (such as satisfaction). In addition, the Descriptive Characteristics Form, which consists of questions such as age and grade, will be applied in the first week of the study.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adolescents who agree to participate in the study and whose parents give written consent,

• Are between the ages of 9-18,
• Have been diagnosed with Type 1 Diabetes at least 6 months ago,
• Have internet access on their smartphone or computer,
• Have no other physiological or psychological illness,
• Do not use psychoactive drugs

Exclusion Criteria:

• Those who use insulin pumps,
• Those who have experienced a significant life event in the last 6 months (such as migration, death, divorce in the family)
• Those who have practiced another body-mind based practice in the last 6 months (such as yoga, guided imagery, etc.)
• Those who do not have internet access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Theraputic Artistic activities group; The group receiving therapeutic artistic activities	Behavioral: Therapeutic Intervention; group where therapeutic art activities such as mandala, drawing, third person singular method are applied. Therapeutic artistic activities within the program (drawing, zentagle, etc.). The program will be implemented in 6 weeks. At the beginning and end of the program, children's anxiety and psychological well-being levels will be evaluated.
No Intervention: Standardized 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 Anxiety Inventory	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 5 weeks (change is being assessed)
Psychological Well-Being Scale	The well-being scale developed by Diener and his colleagues was translated into Turkish by Telef (2013). The Psychological Well-being Scale consists of 8 items. The items of the scale are scored from strongly disagree (1) to strongly agree (7). The scores to be obtained from the scale vary between 8 and 56. The Cronbach alpha coefficient of the scale was calculated as 80.	Change from Baseline level of Adolescent Spiritual Well-Being Scale to 5 weeks (change is being assessed)

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 8, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Estimated): September 13, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 15, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CSOZTURK/23-24

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
• product manufactured in and exported from the U.S.: No