|- candidate number||25504|
|- NTR Number||NTR6116|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-nov-2016|
|- Secondary IDs||NL58728.078.16 MEC-2016-626|
|- Public Title||Virtual reality exposure before elective pediatric day-care surgery: effects on pre- and postoperative anxiety and pain
|- Scientific Title||Virtual reality exposure before elective pediatric day-care surgery: effects on pre- and postoperative anxiety and pain (a randomized controlled trial)
|- hypothesis||1) Virtual Reality Exposure (VRE) will be significantly more efficacious than care as usual (CAU) on both the primary outcome (child’s situational anxiety during induction of anesthesia) and secondary outcomes.
2) Children with unfavorable predictor variables will benefit more from VRE.
Unfavorable predictor variables that will be examined are: SES, age, sex, type of surgery, number of prior surgeries, child anxiety, parental anxiety, and child psychopathology in the previous six months.
|- Healt Condition(s) or Problem(s) studied||Virtual Reality, Anxiety, Children, Surgery, Pain|
|- Inclusion criteria||Consecutive pediatric patients:|
- aged 4-12 years
- undergoing day care elective surgery (i.e. ear-, nose-, throat, dental, or oral surgery) at the Sophia Children’s Hospital
- ASA classification I-III
- undergoing surgery between February 2017 and August 2018
|- Exclusion criteria||- Mental retardation (due to a specified syndrome)|
- Inability of parents to read or write Dutch
- Visual impairment
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2017|
|- planned closingdate||1-aug-2018|
|- Target number of participants||200|
|- Interventions||VRE preparation encompasses an animated virtual, three dimensional (3D) environment that mimics the environment of the operation theatre in the Sophia Children’s Hospital. In the VRE environment, children will look at the specific procedures they will experience in the holding area, operating and recovery room. Children will receive the VRE preparation using 3D glasses within one hour after hospital admission.
The control group will receive care as usual, which means that children and their parents are advised by their anesthesiologist or attending physician to watch the informative online movie of the Erasmus MC-Sophia.
|- Primary outcome||Children’s state anxiety level during induction of anesthesia (measured by the mYPAS, continuous score). |
|- Secondary outcome||- children’s pre- and postoperative anxiety|
- postoperative pain
- emergence delirium
- use of analgesics
- health care use, and
- pre- and postoperative parental anxiety
|- Timepoints||There will be five moments of assessment: |
1) At admission to the hospital before the children will go to the holding area (before the intervention)
2) After the VRE intervention, approximately 15 minutes prior to entering the surgery room. In case of CAU; without intervention, approximately 15 minutes prior to entering the surgery room
3) During induction of anesthesia, in the surgery room
4) Postoperatively, in the recovery room
5) Three days after surgery, at home
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MSc Robin Eijlers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. E.M.W.J. Utens|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|Stichting Theia, Noordwijk, Stichting Coolsingel|
|- Brief summary||About 50% to 70% of children undergoing surgery experience elevated levels of anxiety. Children’s preoperative anxiety is associated with adverse outcomes, such as an increased risk of emergence delirium, more intense and prolonged postoperative pain, and poorer recovery. |
It is well established that gradual exposure to feared situations is a very effective way to reduce anxiety. However, gradually exposing children to the aspects of the pre- and postoperative procedures and environment is not feasible, because this would interfere significantly with daily clinical practice. Virtual Reality Exposure (VRE) provides a unique opportunity to prepare children for their surgery in a very realistic, child friendly and interactive way.
VRE intervention encompasses an animated virtual, three dimensional (3D) environment that mimics the environment of the operation theatre in the Sophia Children’s Hospital. Children will look at the specific procedures they will experience in the holding area, operating and recovery room. Children will receive the VRE preparation using virtual reality 3D glasses within one hour after hospital admission.
In this RCT, patients will be randomly allocated to a) VRE intervention or b) care as usual (CAU). All patients will receive adequate medical care.
The objective is to (1) test the efficacy of VRE versus CAU in 200 children (aged 4-12 years) undergoing day care elective surgery (for dental, oral, or Ear-Nose-Throat problems) – and (2) to examine predictors of VRE efficacy.
|- Main changes (audit trail)|
|- RECORD||3-nov-2016 - 3-jan-2017|