Effects of Virtual Reality on Perioperative Pediatric Anxiety
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Perioperative Anxiety level
Study Overview
Brief Summary
This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.
Detailed Description
It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences.
Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Child between 4 and 12 years old
- •Elective ambulatory surgery
- •Parents posses a smart phone
- •Child and parents understand Spanish or Catalan
- •Patient information has been explained
- •Informed Consent is signed
- •Surgery scheduled in the morning
Exclusion Criteria
- •Child has hearing impairment
- •Child has visual impairment
- •Child has previous experience of anesthesia
- •American Society os Anesthesiologists (ASA) score of III or greater
- •Children with history of seizures
- •Children under psychiatric treatment
Arms & Interventions
Virtual reality program group
Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery.
Intervention: Virtual Reality glasses (Device)
control group
standard perioperative care without virtual reality program
Intervention: standard perioperative care without virtual reality program (Procedure)
Outcomes
Primary Outcomes
Perioperative Anxiety level
Time Frame: baseline to 1 day
In children: measured using the modified Yale Perioperative Anxiety Scale, blinded reported by a trained nurse before the patient is transferred to the operating room. Rage from 23.5 up to 100, deemed high anxiety level if test rated over 30
Secondary Outcomes
- Salivary Cortisol level(baseline to 1 day)
Investigators
Teresa Franco
Principal investigator, Medical Doctor
Germans Trias i Pujol Hospital