Drawing and Writing Activities in Adolescents With Type 1 Diabetes

September 15, 2026 updated by: Çiğdem Sarı Öztürk, Gazi University

Effect of Art-Based Drawing and Writing Activities on Anxiety and Positive and Negative Affect in Adolescents With Type 1 Diabetes: A Parallel-Group Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effects of drawing and writing activities on anxiety and positive and negative affect in adolescents with type 1 diabetes. A total of 50 adolescents aged 9 to 18 years will be randomly assigned to either the intervention or the control group. Participants in the intervention group will take part in a five-day online drawing and writing program, while the control group will receive standard care. Anxiety and positive and negative affect will be assessed before and after the intervention using validated questionnaires. The findings may provide evidence for the use of art-based interventions to support the psychological well-being of adolescents with type 1 diabetes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 1 diabetes is a chronic condition that requires lifelong disease management and may adversely affect the emotional well-being of adolescents. In addition to the physical burden of treatment, adolescents with type 1 diabetes may experience anxiety and fluctuations in positive and negative emotions. Creative, non-pharmacological interventions may facilitate emotional expression and promote psychological adjustment during adolescence.

The aim of this randomized controlled trial is to evaluate the effectiveness of a structured drawing and writing program on anxiety and positive and negative affect in adolescents with type 1 diabetes.

The study is designed as a single-blind, parallel-group randomized controlled trial. Eligible adolescents aged 9 to 18 years with type 1 diabetes will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a structured five-day drawing and writing program in addition to standard diabetes care. The intervention is designed to encourage emotional expression through creative activities, including guided drawing, emotion-focused drawing exercises, and brief reflective writing tasks. Each session will last approximately 25 to 30 minutes and will be delivered individually using standardized instructions.

Participants in the control group will receive standard diabetes care without the drawing and writing intervention.

The primary outcome is anxiety. Secondary outcomes include positive affect and negative affect. Outcome measures will be assessed at baseline and immediately after completion of the intervention using validated self-report instruments.

The findings of this study are expected to provide evidence regarding the effectiveness of an art-based psychosocial intervention for improving the emotional well-being of adolescents living with type 1 diabetes.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06500
        • Recruiting
        • Ankara Bilkent City Hospital
        • Contact:
        • Principal Investigator:
          • cigdem Sari Ozturk, PhD

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

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria Adolescents aged 9 to 18 years. Diagnosed with type 1 diabetes mellitus for at least 6 months. Using an insulin infusion pump. Having access to the internet via a smartphone or computer. Able to understand the study procedures and complete the study questionnaires. Providing written informed assent, with written informed consent obtained from a parent or legal guardian.

Exclusion Criteria Experience of a major life event (e.g., parental divorce, death of a family member, or relocation) within the past 6 months.

Use of a continuous glucose monitoring (CGM) sensor. Diagnosis of a severe psychiatric disorder. Participation in an art-based education or training program within the past 6 months

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drawing and Writing Intervention

Participants in the experimental group will receive a structured five-day drawing and writing intervention in addition to standard diabetes care. The program consists of individual, guided art-based activities designed to facilitate emotional expression and reflection on living with type 1 diabetes. Each daily session will last approximately 25-30 minutes and includes drawing, emotion-focused creative activities, and brief reflective writing. All sessions will be delivered individually by the same trained researcher using standardized instructions.
Other: Drawing and Writing Intervention

Participants assigned to the intervention group will receive a structured drawing and writing intervention in addition to standard diabetes care. The intervention consists of five individual sessions conducted over five consecutive days, each lasting approximately 25-30 minutes. Guided activities include drawing, emotion-focused art exercises, and brief reflective writing designed to facilitate emotional expression and coping with type 1 diabetes. All sessions are delivered individually by the same trained researcher using standardized instructions.
No Intervention: Standard care

Participants in the control group will receive standard diabetes care routinely provided at the pediatric endocrinology clinic. They will not participate in the structured drawing and writing intervention during the study period. Outcome assessments will be conducted at the same time points as in the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety
Time Frame: Baseline (Day 1, before the intervention) and immediately after completion of the intervention (Day 5).

State anxiety will be assessed using the State Anxiety Inventory for Children (SAIC). The SAIC is a validated self-report instrument consisting of 20 items scored on a 3-point Likert scale. Total scores range from 20 to 60, with higher scores indicating greater state anxiety.
Baseline (Day 1, before the intervention) and immediately after completion of the intervention (Day 5).
State Anxiety
Time Frame: Baseline and Day 5 (immediately after completion of the intervention)

State anxiety will be assessed using the State Anxiety Inventory for Children (SAIC). Scores range from 20 to 60, with higher scores indicating greater state anxiety.
Baseline and Day 5 (immediately after completion of the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Affect
Time Frame: Baseline and Day 5 (immediately after completion of the intervention)

Positive affect will be assessed using the Short Positive and Negative Affect Scale for Children (PANAS-C-SF). Higher scores indicate greater positive affect.
Baseline and Day 5 (immediately after completion of the intervention)
Negative Affect
Time Frame: Baseline and Day 5 (immediately after completion of the intervention)

Negative affect will be assessed using the Short Positive and Negative Affect Scale for Children (PANAS-C-SF). Higher scores indicate greater negative affect.
Baseline and Day 5 (immediately after completion of the intervention)

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)

April 6, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 15, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gazi University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available because of privacy and confidentiality considerations and the lack of participant consent for public data sharing.

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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