Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy
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|ClinicalTrials.gov Identifier: NCT03578393|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Virtual Reality||Device: Virtual Reality Educational Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy|
|Actual Study Start Date :||February 2, 2019|
|Estimated Primary Completion Date :||September 2, 2019|
|Estimated Study Completion Date :||September 2, 2020|
Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.
Device: Virtual Reality Educational Program
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.
No Intervention: Usual treatment
Will be applied the usual treatment (provide information on the anaesthetic-surgical process).
- Preoperative Change of Paediatric Anxiety level [ Time Frame: 3 days: 1.- On preanesthetic visit (7-10 days before surgery), 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. ]
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.
- Paediatric pain [ Time Frame: 2 days. The surgery day and the postoperative day (24 hours after surgery). ]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.
- Modified Aldrete postanesthetic recuperation [ Time Frame: 1 day. The surgery day ]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.
- Parental satisfaction [ Time Frame: 1 day. At hospital discharge (24 hours after surgery). ]Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.
- Resources [ Time Frame: 1 day. The surgery day. ]
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)
- Children's collaboration during anaesthesia induction. [ Time Frame: 1 day. The surgery day, 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.
- Paediatric Delirium [ Time Frame: 2 days. The surgery day and the postoperative day (24 hours after surgery). ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578393
|Contact: Adriana Carbó García, Nursefirstname.lastname@example.org|
|Contact: Adriana Carbó García, Nurseemail@example.com|
|Centro Medico Teknon||Recruiting|
|Barcelona, Spain, 08012|
|Contact: Adriana Carbó, Nurse 650073209 firstname.lastname@example.org|
|Principal Investigator:||Adriana Carbó García, Nurse||Servicio Central de Anestesiología|