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Enrolling by Invitation

NCT Number: NCT06595173

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

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).

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Therapeutic Artistic Activities in Adolescent with Diabetes

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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