An interventional study of Virtual Reality Educational Program in Anxiety and Virtual Reality, sponsored by Servei Central d'Anestesiologia. Completed at 1 site in Spain. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by Servei Central d'Anestesiologia · Not applicable, Interventional, and Prevention
This study evaluate the effectiveness of the Virtual Reality Educational Program (RVEP) in the Paediatric Surgical Prehabilitation Unit to reduce the perioperative anxiety in children who undergo to elective surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.
During preoperative time, anxiety is one of the most frequent problems in children, causing an important health problem as long with pain. In the surgical fields there are two especially stressful moments for the child, the first one is the parent´s separation, and the second is the anaesthetic induction, which in up to 42% of cases can be traumatic.
Methods to treat paediatric anxiety have evolved in the last decades. Pharmacological therapy is one of the most used methods to treat anxiety in the immediate preoperative period, but complications and unwanted side effects are described. Due to this side effects, this study will evaluate the the effectiveness of the Virtual Reality Educational Program (RVEP) to reduce the perioperative anxiety in children.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 241 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Servei Central d'Anestesiologia is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.
Device: Virtual Reality Educational Program
Will be applied the usual treatment (provide information on the anaesthetic-surgical process).
The study group, in addition to providing the usual information about the anaesthetic-surgical process, will visualize an educational video through virtual reality glasses, of a maximum duration of 5 minutes. The video's explanation will be adapted according to the age ranges. Once the video is finished, if there aren't doubts, the visit will be concluded.
Preoperative Change of Paediatric Anxiety level
It will be measured by modified-Yale Preoperative Anxiety Scale (mYPAS) and its short form (mYPAS-SF). The mYPAS score range is: 23,3 to 100, majors scores indicate anxiety. It's considerate an anxiety cut-off point scores \>40, and no anxiety \<40. The mYPAS-SF score range is 22,7 to 100.
Time frame: 3 days: 1.- On preanesthetic visit, using mYPAS scale. 2.- The surgery day, during parents separation, using mYPAS-SF. 3.- Postoperative day (24 hours after surgery), at hospitalization room, using a mYPAS scale.
Paediatric pain
Measured by Faces Pain Rating Scale o Wong Baker Faces. It consist in 6 faces, The faces represent "no harm" to "worse damage" and the score goes from 0 to 10.
Time frame: 2 days. The surgery day and the postoperative day (24 hours after surgery).
Modified Aldrete postanesthetic recuperation
It is a hetero-administered scale consisting of 10 items. Each item responds to a Likert scale of 0 to 2, with a total range ranging from 0 to 10. The cut-off point is at 80% of the maximum score, ie 18 points suggest adequate recovery after anesthesia.
Time frame: 1 day. The surgery day
Parental satisfaction
Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.
Time frame: 1 day. At hospital discharge (24 hours after surgery).
Resources
Will be measured using a self-created questionnaire. It contains variables as: * Anaesthesia induction times (in minutes) * Time between the surgery ends and recovery discharge (in minutes) * Surgery times (in minutes)
Time frame: 1 day. The surgery day.
Children's collaboration during anaesthesia induction.
It will be measured by Induction Compliance Checklist (ICC). ICC score range is 0 to 10, 0 means collaborate and 10 no collaborate.
Time frame: 1 day. The surgery day, during anaesthesia induction.
Paediatric Delirium
Paediatric Anesthesia Emergence Delirium (PAED). It consists of 5 items with 5 possible answers on a scale of 0 to 4, with a score of \> 10 indicating postsurgical agitation.
Time frame: 2 days. The surgery day and the postoperative day (24 hours after surgery).
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Servei Central d'Anestesiologia