Interactive Digital Art-Based Relaxation Program (NCT07388485) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Interactive Digital Art-Based Relaxation Program
60 participantsStarted 2026-01-20
Plain-language 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.
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
State Anxiety Level in Children
Timeframe: At baseline and immediately post-intervention
2
Respiratory Rate
Timeframe: At baseline and immediately post-intervention
3
Emotional Distress Level
Timeframe: At baseline and immediately post-intervention
4
Blood Pressure
Timeframe: At baseline and immediately post-intervention
5
Oxygen Saturation
Timeframe: At baseline and immediately post-intervention
6
Pain Intensity:
Timeframe: At baseline and immediately post-intervention