Interactive Digital Art-Based Relaxation Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interactive Digital Art-Based Relaxation Program.
- Who it may be relevant to
- Registry conditions: Pediatric Critical Illness, Anxiety. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of an Interactive Digital Art-Based Relaxation Program on Physiological Parameters, Anxiety, and Emotional Distress in Children Receiving Treatment in the Pediatric Intensive Care Unit: A Randomized Controlled Trial
Overview
This randomized controlled trial aims to evaluate the effects of an Interactive Digital Art-Based Relaxation Program on physiological parameters, anxiety levels, and emotional distress in children aged 7-12 years receiving care in a pediatric intensive care unit (PICU). Children in the intervention group will receive three short, nurse-guided digital art-based relaxation sessions delivered via tablet, while the control group will receive standard PICU nursing care. Outcomes will be assessed using physiological measurements and validated psychological assessment tools before and after the intervention.
Detailed description
Children hospitalized in pediatric intensive care units are exposed to multiple stressors, including invasive procedures, environmental noise, physical discomfort, and separation from family members. These factors may lead to increased anxiety, emotional distress, and physiological dysregulation, even in children who are conscious and not receiving sedation. There is a growing need for brief, feasible, and child-friendly non-pharmacological interventions that can be safely implemented in the PICU setting to support emotional well-being and physiological stability.
This study is designed as a parallel-group, randomized controlled trial to evaluate the effectiveness of an Interactive Digital Art-Based Relaxation Program in reducing anxiety and emotional distress and improving physiological parameters in children aged 7-12 years receiving care in a pediatric intensive care unit. The study will be conducted between February 2026 and March 2027 in the Pediatric Intensive Care Unit of Etlik City Hospital, Ministry of Health.
A total of 60 children who meet the inclusion criteria will be randomly assigned to either the intervention group (n = 30) or the control group (n = 30) using simple randomization. Randomization will be performed by an independent statistician using a computerized randomization tool. Eligible participants will be conscious, hemodynamically stable, not receiving continuous sedative or analgesic infusion, and able to follow verbal instructions.
Children in the intervention group will receive an Interactive Digital Art-Based Relaxation Program consisting of three sessions. Each session will last approximately 8-10 minutes and will be delivered via a tablet under nurse guidance. The program integrates interactive digital art activities with relaxation components designed to promote emotional expression, attention regulation, and calming responses. The control group will receive standard pediatric intensive care nursing care without additional psychosocial intervention.
Data will be collected at baseline and after completion of the intervention. Baseline assessments will include a descriptive characteristics form, physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation, and pain), the State Anxiety Inventory for Children, and the Emotion Thermometer. Physiological parameters will also be recorded immediately before and after each intervention session. Post-intervention assessments will include repeated physiological measurements, the State Anxiety Inventory for Children, and the Emotion Thermometer.
The primary outcomes of the study are changes in physiological parameters and anxiety levels. Secondary outcomes include changes in emotional distress levels. It is hypothesized that children who participate in the Interactive Digital Art-Based Relaxation Program will demonstrate improved physiological stability, reduced anxiety, and lower emotional distress compared to those receiving standard care.
The findings of this study are expected to contribute to evidence-based pediatric intensive care nursing practices by providing support for the integration of short, technology-assisted, art-based psychosocial interventions into routine clinical care.
Interventions
- Other Interactive Digital Art-Based Relaxation Program
The Interactive Digital Art-Based Relaxation Program is a nurse-guided, technology-assisted psychosocial intervention designed for children aged 7-12 years receiving care in the pediatric intensive care unit. The program consists of three individual sessions delivered via a tablet device. Each session lasts approximately 8-10 minutes and integrates interactive digital art activities with guided breathing, emotional awareness, and relaxation techniques. During the sessions, children are encourag
Primary outcome measures
- State Anxiety Level in Children [Time frame: At baseline and immediately post-intervention]
- Respiratory Rate [Time frame: At baseline and immediately post-intervention]
- Emotional Distress Level [Time frame: At baseline and immediately post-intervention]
- Blood Pressure [Time frame: At baseline and immediately post-intervention]
- Oxygen Saturation [Time frame: At baseline and immediately post-intervention]
- Pain Intensity: [Time frame: At baseline and immediately post-intervention]
Eligibility criteria
Inclusion criteria
- • Be between 7 and 12 years of age
- Be conscious and able to respond to commands
- Not be receiving sedative/analgesic infusion or be at minimal sedation level (RASS ≥ -1)
- Have been monitored in intensive care for at least 24 hours
- Have stable vital signs
- Have no visual or auditory perception loss
- Parental consent and verbal consent from the child must have been obtained
Exclusion criteria
- Severe neurological deficit or motor impairment
- Severe pain, delirium, or agitation
- Severe psychiatric diagnosis or requirement for high-dose sedation
- Being in the terminal phase
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 1. Amin, F. M., Ayed, M. M. A., & Mahmoud, N. F. (2022). Effect of Benson relaxation therapy on sleep quality among children in pediatric intensive care unit. International journal of health sciences, 6(S8), 6605-6619. 2. Apriany, D., Rakhmawati, W., Iskandarsyah, A., & Hilmanto, D. (2025). The Effect of The Mindfulness-Based Relaxation, Aromatherapy, and Prayer (RADO) Intervention on Anxiety and
Identifiers
NCT: NCT07388485 · 2025-2215