Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 241
- Locations
- 2
- Primary Endpoint
- Preoperative Change of Paediatric Anxiety level
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children between 3 and 12 years old.
- •Elective surgical intervention.
- •ASA I-II (classification of the American Society of Anesthesiologists).
- •Surgical complexity grade I-II according to National Institute for Clinical Excellence of the NHS.
- •General anesthesia.
- •Spanish or Catalan speaking families.
- •Understanding the study and signing the informed consent of the study by parents or legal guardians.
Exclusion Criteria
- •Patients suffering from psychiatric or mental illness, psychomotor retardation, blindness or deafness.
- •Denial of parents / legal guardians and / or children.
- •Ambulatory surgery.
- •Surgical intervention of the child the year before the current one.
Outcomes
Primary Outcomes
Preoperative Change of Paediatric Anxiety level
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.
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.
Secondary Outcomes
- Modified Aldrete postanesthetic recuperation(1 day. The surgery day)
- Paediatric pain(2 days. The surgery day and the postoperative day (24 hours after surgery).)
- Paediatric Delirium(2 days. The surgery day and the postoperative day (24 hours after surgery).)
- Parental satisfaction(1 day. At hospital discharge (24 hours after surgery).)
- Children's collaboration during anaesthesia induction.(1 day. The surgery day, during anaesthesia induction.)
- Resources(1 day. The surgery day.)
Investigators
Adriana Carbó García
Nurse
Servei Central d' Anestesiologia