orthopedic, urological and general pediatric surgical procedures
Conditions
Interventions
Virtual Reality intervention.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Age 6 – 18 years old at inclusionAmerican Society of Anesthesiologists (ASA) classification status I-IIIAdmitted to the hospital for at least two nights postoperativelyUndergoing one of the following surgical procedures with an estimated length of hospital stay of at least 2 nights postoperatively:LaparotomyLaparoscopyOrthopedic or trauma surgeryScoliosis surgeryThoracotomyThoracoscopyNuss bar procedure for pectus excavatumRavitch procedure for pectus excavatumInformed consent from patient and/or parents or legal representatives (depending on the age)
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Developmental delayAdmitted to the Intensive Care Unit (ICU) because of mechanical ventilation or sedationASA classification status IV-VSedated postoperativelyHistory of epilepsySevere visual impairment Head woundsNot able to understand or read Dutch (child and/or parents)Included in another clinical study on postoperative pain or another clinical study in which a participant is subject to the Medical Research Involving Human Subjects Act (WMO).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is postoperative pain assessed by NRS Pain. NRS Pain scores will be assessed at specified time points three times per day (e.g., on regular time intervals during the day (every 8 hours, and immediate before and after the VR experience)) to capture pain intensity variations during the first three postoperative days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity, anxiety and stressor-related problems, sleep quality, quality of recovery, opioid/analgesics use, incidence of chronic postsurgical pain, acceptability, usability and user satisfaction, difference in efficacy of VR interventions (distraction vs. relaxation), cost-effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactL.M. Staals
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed