Interactive Digital Art-Based Relaxation Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorGazi University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Interactive Digital Art-Based Relaxation Program
Other interventionThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline and immediately post-intervention2
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.
Time frame
At baseline and immediately post-intervention3
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.
Time frame
At baseline and immediately post-intervention4
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).
Time frame
At baseline and immediately post-interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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