pediatric patients with anesthesia especially for pediatric surgery (esp. thoracic, visceral, urologic surgery), also ENT-, orthopedic-, oral and maxillofacial-, plastic-, neuro-surgery
Conditions
Interventions
Group 1: single-arm pilotstudy, observational study:
Pediatric patients, who
The enrolled pediatric patients, if necessary supported by their legal guardians, are asked to provide data on pain intens
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Age
4 Years to 18 Years
Inclusion criteria
Inclusion criteria: • Pediatric patients aged 4 – 18 years undergoing surgical procedures with anesthesia • ASA (American Society of Anesthesiologists) Classification 1-3 • Planned surgical procedures that can be performed either as day surgery or with one overnight stay • Anesthesia and/or regional anesthesia • Availability of a parent or legal guardian to assist with postoperative data reporting • Written informed consent from parents/guardians and, where appropriate, patient assent
Exclusion criteria
Exclusion criteria: • Pediatric Patients 3 • Major surgical procedures with an estimated inhospital stay of more than one night or a planned postoperative ICU stay • Patients with cognitive or developmental impairments that would hinder the use of the application or accurate data reporting • Parents/guardians unable to use the mobile or web-based system due to technological limitations • Language barrier
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility metrics: - retention rate (defined as the proportion of enrolled patients who fully complete the planned assessments up to the specified time points) - recruitment rate (Screened, Eligible, Consent, and Enrolment Rates) - data completeness rate | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain intensity (visual analog scale with child-friendly emojis derived from the WBFPRS) - Nausea and vomiting (visual analog scale with child-friendly emojis derived from the BARF scale) - Degree of agitation (visual analog scale) - Satisfaction with treatment (visual analog scale) - Sleep quality (visual analog scale) - App usage metrics (including the Login frequency, response latency, and proportion of completed items) | — |
Countries
Austria
Contacts
Public ContactMira Zeilberger
Medizinische Universität Wien
Outcome results
None listed