Interactive Digital Art-Based Relaxation Program

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Pediatric Critical Illness
• Intervention / Treatment: Other: Interactive Digital Art-Based Relaxation Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Received Standard Care
Experimental: Intervention Group; Received Interactive Digital Art-Based Relaxation Program	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 encouraged to engage in simple digital art creation (e.g., drawing, color selection, and visual expression) while following age-appropriate breathing and relaxation prompts provided by the nurse. The intervention is designed to promote emotional expression, reduce anxiety, and support physiological stabilization by facilitating relaxation and emotional regulation. All sessions are conducted at the bedside under nurse supervision and are tailored to the child's clinical condition and tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Anxiety Level in Children	State anxiety will be measured using the State Anxiety Inventory for Children, developed by Spielberger. The scale consists of 20 items assessing how children feel at the present moment, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety. The Turkish version of the scale has demonstrated good reliability and validity in children and adolescents.	At baseline and immediately post-intervention
Respiratory Rate	Respiratory rate will be measured as a physiological stress parameter using standard bedside monitoring systems routinely used in the pediatric intensive care unit. Respiratory rate will be recorded as breaths per minute.	At baseline and immediately post-intervention
Emotional Distress Level	Emotional distress will be assessed using the Emotion Thermometer, a validated self-report tool adapted for use in Turkish children. Children will be asked to rate the intensity of five basic emotions (sadness, anxiety, fear, happiness, and calmness) on a numeric scale ranging from 0 (not experienced at all) to 10 (extremely intense). Higher scores indicate greater emotional intensity. The tool has demonstrated high internal consistency reliability.	At baseline and immediately post-intervention
Blood Pressure	Systolic and diastolic blood pressure will be assessed non-invasively using standard bedside monitoring devices in the pediatric intensive care unit. Blood pressure values will be recorded in millimeters of mercury (mmHg).	At baseline and immediately post-intervention
Oxygen Saturation	Oxygen saturation will be evaluated using pulse oximetry as part of routine bedside monitoring in the pediatric intensive care unit. Oxygen saturation values will be recorded as percentages (%)	At baseline and immediately post-intervention
Pain Intensity:	Pain intensity be assessed using the Wong-Baker Faces Pain Rating Scale, a validated self-report measure appropriafor children based on age and communication ability. The scale allows children to indicate their level of pain using facial expressions.	At baseline and immediately post-intervention

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General 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 Quality of Life Among Children with Cancer. Journal of Multidisciplinary Healthcare, 1381-1392. 3. Bahcivan, O. & Eyrenci, A. (2018). The adaptation of Emotion Thermometer (ET) for Turkish speaking population. Psycho-Oncology 27: 215-216, 4. Bucur, S. M., Crișan, I. M., Cocoș, D. I., Bud, E. S., & Galea, C. (2025). Observational Study on Progressive Muscle Relaxation and Breathing Control for Reducing Dental Anxiety in Children. Medicina, 61(5), 876. 5. Ferro, M. M., Pegueroles, A. F., Lorenzo, R. F., Roy, M. Á. S., Forner, O. R., Jurado, C. M. E., ... & Alcaraz, A. B. (2023). The effect of a live music therapy intervention on critically ill paediatric patients in the intensive care unit: A quasi-experimental pretest-posttest study. Australian Critical Care, 36(6), 967-973. 6. Galinha, I. C., de Carvalho, J. L. D. C. S., de Oliveira, A. C. P., Arriaga, P., Gaspar, A. D., Silva, H. P., & Ortega, V. (2025). MindRegulation-SEL: randomized controlled trial of the effects of a relaxation and guided imagery intervention with socioemotional learning on the psychological and biophysiological well-being, socioemotional development, cognitive function and academic achievement of elementary school children. Trials, 26(1), 187. 7. Kalsotra, S., Froass, D., Gupta, A., Amaya, S., Tobias, J. D., & Olbrecht, V. A. (2025). Virtual Reality for Pediatric Postoperative Pain Management: Exploring Methods and Efficacy. Journal of Medical Internet Research, 27, e68348. 8. Köksal, Ö., Kilicarslan, E., & Emeksiz, S. (2025). Drawing and mutual storytelling to alleviate anxiety and improve emotional

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): March 20, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Children; Pediatric Intensive Care Unit; Interactive Digital Art-Based Relaxation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2025-2215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision regarding the sharing of individual participant data has not yet been made. Any future data sharing will be considered following completion of the study, in accordance with ethical approval, participant consent, and applicable data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No