Pediatric Preoperative Virtual Reality Program (PPVRP)

Thoralf Liebs

Status: Terminated

Conditions: Surgery; Anxiety

Treatments: Other: Pre-Operative Preparatory Virtual Reality Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03957525

2019-00081

Details and patient eligibility

About

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?

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 6 patient groups

Orthopaedic Intervention group

Experimental group

Description:

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.

Treatment:

Other: Pre-Operative Preparatory Virtual Reality Program

Orthopaedic Control group

No Intervention group

Description:

Gets written and oral preparation for surgery

Urologic Intervention group

Experimental group

Description:

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.

Treatment:

Other: Pre-Operative Preparatory Virtual Reality Program

Urologic Control group

No Intervention group

Description:

Gets written and oral preparation for surgery

General Paediatric Surgery Intervention group

Experimental group

Description:

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.

Treatment:

Other: Pre-Operative Preparatory Virtual Reality Program

General Paediatric Surgery Control group

No Intervention group

Description:

Gets written and oral preparation for surgery