Drawing and Writing Activities in Adolescents With Type 1 Diabetes

NCT07830082 | Recruiting

• 1 other identifier: Gazi University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Type 1 Diabetes Mellitus (T1DM)

Keywords

Type 1 diabetes; Adolescents; Art-based intervention; anxiety; drawing

Outcome Measures

Primary Outcomes (2)

• State Anxiety

  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

  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 Outcomes (2)

• Positive Affect

  Baseline and Day 5 (immediately after completion of the intervention)

• Negative Affect

  Baseline and Day 5 (immediately after completion of the intervention)

Study Arms (2)

Drawing and Writing Intervention

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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.

Interventions

Drawing and Writing Intervention OTHER

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.

Drawing and Writing Intervention

Eligibility Criteria

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Anxiety Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders

Central Study Contacts

Çiğdem SARI ÖZTÜRK, PhD

CONTACT

90 312 216 26 63; cigdemsari@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Group allocation was concealed using sequentially numbered, sealed, opaque envelopes until randomization. Participants were enrolled and treated individually to minimize contamination between study groups. Outcome assessment and statistical analyses were performed using coded data. The statistician and outcome assessors were blinded to group allocation. Due to the nature of the intervention, the researcher delivering the intervention was aware of group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive a structured five-day drawing and writing program in addition to standard care, whereas the control group will receive standard care alone. Outcomes will be assessed at baseline and immediately after completion of the intervention

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)