Emergence Delirium, Maladaptive Postoperative Behavior, Preoperative Anxiety
Conditions
Keywords
virtual reality, pediatric surgery
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.
Interventions
DEVICEVirtual Reality glasses
Children are encouraged to watch the virtual reality program at least 24 hours before surgery.
PROCEDUREstandard perioperative care without virtual reality program
standard perioperative care without virtual reality program
Sponsors
Germans Trias i Pujol Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Anxiety level | 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
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol level | baseline to 1 day | In children: Saliva sample collection using Salivette system before the patient is transferred to the operating room. Levels over 8nmol/l can be caused by high anxiety level |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety levels | baseline to 1 day | In parents: State Anxiety Inventory Scale, self questionnaire made of 20 questions rated from 0 to 3 at the holding area. Range from 1 up to 10 |
Countries
Spain
Contacts
Primary ContactTeresa Franco, MD
Outcome results
None listed