ClinicalTrials.gg
RecruitingNCT07830082Updated Sep 21, 2026

Drawing and Writing Activities in Adolescents With Type 1 Diabetes

An interventional study of Drawing and Writing Intervention in Type 1 Diabetes Mellitus (T1DM) and Anxiety, sponsored by Gazi University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Gazi University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2026, registered Sep 2026).
  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
9 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 75 studies in Diabetes Mellitus, Type 1 with a site in Turkey — 13 open to participants now, 15 under way, none of them phase 3. Diabetes Mellitus, Type 1 · Turkey.

Planned enrollment
28th of 47
50 · median 58
Started
2026
with 5 others
No phase
37 of 75
10 open now
Primary completion
2026-12
later than 12 of 14 live
Registered
73rd of 75
by date
Lead sponsor
3 of 75
Gazi University

Among the 75 studies in Diabetes Mellitus, Type 1 with a site in Turkey, this one is the 28th largest by planned enrollment of the 47 interventional ones that give a count, is one of 6 that started in 2026, is one of 37 with no phase, reaches primary completion later than 12 of the 14 other live ones, and was the 73rd registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

13 of the 75 studies in Diabetes Mellitus, Type 1 with a site in Turkey are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.

This study: 9 Years to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 75 studies in Diabetes Mellitus, Type 1 with a site in Turkey, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Type 1 Diabetes Mellitus (T1DM)
  • Anxiety

Keywords

  • Type 1 diabetes
  • Adolescents
  • Art-based intervention
  • anxiety
  • drawing
04

Who can participate

Ages eligible
9 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherDrawing 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (Day 1, before the intervention) and immediately after completion of the intervention (Day 5).

  2. 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.

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

Secondary outcomes

  1. Positive Affect

    Positive affect will be assessed using the Short Positive and Negative Affect Scale for Children (PANAS-C-SF). Higher scores indicate greater positive affect.

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

  2. Negative Affect

    Negative affect will be assessed using the Short Positive and Negative Affect Scale for Children (PANAS-C-SF). Higher scores indicate greater negative affect.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.

Of 845 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 8 months is below that.

Counting every sponsor, half of 950 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartActual
Apr 6, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07830082
Lead sponsor
Gazi University
Responsible party
Çiğdem Sarı Öztürk (Associate Professor, Gazi University) — Principal investigator
First posted
Sep 21, 2026
Start date
Apr 6, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 21, 2026

Study contacts

Çiğdem SARI ÖZTÜRK, PhD
Contact
cigdemsari@gazi.edu.tr
90 312 216 26 63

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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