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

NCT06595173 | Enrolling By Invitation

• 1 other identifier: CSOZTURK/23-24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Adolescent; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Theraputic Artistic activities group

EXPERIMENTAL

The group receiving therapeutic artistic activities

Behavioral: Therapeutic Intervention

Standardized Control Group

NO INTERVENTION

the group that did not receive any training

Interventions

Therapeutic Intervention BEHAVIORAL

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.

Theraputic Artistic activities group

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Gocen O, Ozturk CS. The effect of therapeutic artistic activities on anxiety and psychological well-being in adolescents with type 1 diabetes: a randomized controlled study. Eur J Pediatr. 2025 Jun 3;184(7):386. doi: 10.1007/s00431-025-06237-y.

  PMID: 40461873 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gazi University

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: April 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)