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Clinical Trials/NCT06595173
NCT06595173Enrolling By InvitationNot Applicable

Therapeutic Artistic Activities in Adolescent with Diabetes

Gazi University1 site in 1 country70 target enrollmentStarted: April 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
70
Locations
1
Primary Endpoint
Spielberger State Anxiety Inventory

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
9 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Çiğdem Sarı Öztürk

Gazi University

Gazi University

Study Sites (1)

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