Clinical trial NCT03957525: Pediatric Preoperative Virtual Reality Program
Official title: The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Anxiety
Keywords: Virtual reality
Pediatric
Anxiety
Surgery
Anesthesia
Intervention
Exposure
Randomized controlled trial
Pediatric urology
Orthopedic surgery
General Pediatric surgery
Pediatric orthopedics
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 11
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized, controlled trial
Primary purpose: OTHER

Brief summary: Does the introduction of a preparatory virtual reality (VR) program that is used in the home environment, have an effect on the anxiety level of children immediately before surgery, prior to administration of preoperative sedatives?

Detailed description: Up to 60% of children who require elective surgery report significant anxiety in the preoperative setting. Severe perioperative anxiety of a child poses a major challenge for the surgeon, since it is often accompanied by adverse behavioral and emotional reactions and associated with a complicated operative and postoperative course.

The investigators have made the personal experience that informing the children ahead of time about what to expect in the hospital, decreases child anxiety and increases parent satisfaction.

There is considerable debate on the best way how to inform children about what to expect during their hospital stay. The investigators had a virtual reality application developed that introduces the children to several aspects of the hospital environment. Therefore, these children now ahead of time what they will experience during their hospital stay.

The aim is to evaluate the effect of this preparatory virtual reality application on the anxiety level of children immediately before surgery.

Eligibility criteria: Inclusion Criteria:

1. The child is between the age of 7 and 13 years
2. The child is undergoing an elective surgical procedure under general anesthesia
3. The child understands Swiss German
4. The parent(s) understand(s) German
5. The parent(s) possess a smart phone
6. Internet access is given
7. The patient information has been explained
8. Informed Consent is signed

Exclusion Criteria:

1. The child has a hearing impairment
2. The child has neurologic disorder
3. The child requires postoperative intensive care
4. The child has previous experience of anesthesia
5. American Society of Anesthesiologists (ASA) score of III or greater

Primary outcomes:
measure: Perioperative anxiety level of children immediately before surgery (VAS-A)
timeFrame: 2 - 90 days after recruiting
Secondary outcomes:
measure: Perioperative anxiety level of Children VAS-A
timeFrame: 2 - 90 days after recruiting
measure: Perioperative anxiety level of Children VFAS
timeFrame: 2 - 90 days after recruiting
measure: Perioperative anxiety level of accompanying parent
timeFrame: 14 - 110 days after recruiting
measure: Non-disease specific secondary Outcomes
timeFrame: 14 - 110 days after recruiting
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern, Clinic for Pediatric Surgery
Study officials:
affiliation: Department of Pediatric Surgery, Inselspital
name: Thoralf Randolf Liebs, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: