Pediatric Preoperative Virtual Reality Program

Not Applicable

Terminated

• Conditions: Surgery; Anxiety
• Interventions: Other: Pre-Operative Preparatory Virtual Reality Program

• Registration Number: NCT03957525
• Lead Sponsor: Thoralf Liebs

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.

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-21
• Study Start: 2019-08-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Paediatric Surgery Intervention group	Pre-Operative Preparatory Virtual Reality Program	In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin.
Urologic Intervention group	Pre-Operative Preparatory Virtual Reality Program	In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin.
Orthopaedic Intervention group	Pre-Operative Preparatory Virtual Reality Program	In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin.

Primary Outcome Measures

Name	Time	Method
Perioperative anxiety level of children immediately before surgery (VAS-A)	2 - 90 days after recruiting	Perioperative anxiety level of children as measured by the Visual Analog Scale for Anxiety (VAS-A), immediately before surgery, prior to administration of preoperative sedatives (T2).; The VAS-A scale consists of a 10 cm long, horizontal line, supplemented by two labels: "no anxiety or fear" at the left end, "worst possible anxiety or fear" at the right end of the scale.

Secondary Outcome Measures

Name	Time	Method
Perioperative anxiety level of Children VAS-A	2 - 90 days after recruiting	Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A.
Perioperative anxiety level of Children VFAS	2 - 90 days after recruiting	Perioperative anxiety level of children as measured by the Visual Faces Analog Scale (VFAS) scale at T0, T1, T2 and T3.; The VFAS scale consists of six different drawings of faces, supplemented by labels as follows: ("Anxiety Level:", "none", "mild", "mild-moderate", "moderate", "moderate-high", "highest")
Perioperative anxiety level of accompanying parent	14 - 110 days after recruiting	Perioperative anxiety level of accompanying parent measured at T0, T1 and T2 with the VAS-A and VFAS scale
Non-disease specific secondary Outcomes	14 - 110 days after recruiting	The investigators want to evaluate to which extent the VR program is able to improve the patient and parent's level of preparedness for surgery. Unfortunately, there are currently no validated outcome measures available covering these issues. Therefore, we developed a questionnaire assessing the level of preparedness related to seven aspects of the hospital stay, which are particularly illustrated by the VR program.

Trial Locations

Locations (1)

Inselspital Bern, Clinic for Pediatric Surgery; 🇨🇭 Bern, Switzerland