AdolescentNCT06595173
Effects of Therapeutic Artistic Activities on the Mental Status of Adolescents Followed Up with Diabetes Diagnosis
A study testing Therapeutic Intervention in people with Adolescent and Diabetes, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Adolescent, Diabetes
- What is being tested?
- Therapeutic Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Adolescent, Diabetes
- Being tested
- Therapeutic Intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Theraputic Artistic activities group | Experimental | The group receiving therapeutic artistic activities Receives: Behavioral: Therapeutic Intervention |
| Standardized Control Group | No intervention | the group that did not receive any training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline level of Adolescent Spiritual Well-Being Scale to 5 weeks (change is being assessed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdolescentStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Sarı Öztürk, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595173
- Sponsor's protocol ID
- CSOZTURK/23-24
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40461873
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Artistic Activities in Adolescent with Diabetes
- ClinicalTrials.gov ID
- NCT06595173
- Acronym / sponsor ID
- CSOZTURK/23-24
- Conditions
- Adolescent, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theraputic Artistic activities group | Experimental | Behavioral: Therapeutic InterventionThe group receiving therapeutic artistic activities |
| Standardized Control Group | No intervention | –the group that did not receive any training |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Interventiongroup 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. | Behavioural | Theraputic Artistic activities group |
Primary outcome
Spielberger State Anxiety Inventory
Time frame: Change from Baseline level of Spielberger State-Trait Anxiety to 5 weeks (change is being assessed)
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.
Psychological Well-Being Scale
Time frame: Change from Baseline level of Adolescent Spiritual Well-Being Scale to 5 weeks (change is being assessed)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40461873Gocen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Intervention in people with Adolescent and Diabetes, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger State Anxiety Inventory (time frame: Change from Baseline level of Spielberger State-Trait Anxiety to 5 weeks (change is being assessed)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.