Interactive Digital Art-Based Relaxation Program

NCT07388485 | Not Yet Recruiting

• 1 other identifier: 2025-2215
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anxiety; Pediatric Critical Illness

Keywords

Pediatric Intensive Care Unit; Children; Interactive Digital Art-Based Relaxation

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

Received Standard Care

Intervention Group

EXPERIMENTAL

Received Interactive Digital Art-Based Relaxation Program

Other: Interactive Digital Art-Based Relaxation Program

Interventions

Interactive Digital Art-Based Relaxation Program OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and intervention providers cannot be blinded. However, outcome assessment will be performed by a researcher who is blinded to group allocation. The outcome assessor will not be involved in the intervention delivery and will be unaware of participants' group assignments to minimize assessment bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Research Assistant

Model Details: This study is a parallel-group randomized controlled trial. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive an interactive digital art-based relaxation program in addition to standard pediatric intensive care, while the control group will receive standard pediatric intensive care alone. Outcomes will be assessed at baseline and after completion of the intervention, with no crossover between groups.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 5, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): March 20, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01