NCT03957525

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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

May 17, 2019

Last Update Submit

April 16, 2020

Conditions

SurgeryAnxiety

Keywords

Virtual realityPediatricAnxietySurgeryAnesthesiaInterventionExposureRandomized controlled trialPediatric urologyOrthopedic surgeryGeneral Pediatric surgeryPediatric orthopedics

Outcome Measures

Primary Outcomes (1)

  • Perioperative anxiety level of children immediately before surgery (VAS-A)

    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.

    2 - 90 days after recruiting

Secondary Outcomes (4)

  • Perioperative anxiety level of Children VAS-A

    2 - 90 days after recruiting

  • Perioperative anxiety level of Children VFAS

    2 - 90 days after recruiting

  • Perioperative anxiety level of accompanying parent

    14 - 110 days after recruiting

  • Non-disease specific secondary Outcomes

    14 - 110 days after recruiting

Study Arms (6)

Orthopaedic Intervention group

EXPERIMENTAL

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.

Other: Pre-Operative Preparatory Virtual Reality Program

Orthopaedic Control group

NO INTERVENTION

Gets written and oral preparation for surgery

Urologic Intervention group

EXPERIMENTAL

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.

Other: Pre-Operative Preparatory Virtual Reality Program

Urologic Control group

NO INTERVENTION

Gets written and oral preparation for surgery

General Paediatric Surgery Intervention group

EXPERIMENTAL

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.

Other: Pre-Operative Preparatory Virtual Reality Program

General Paediatric Surgery Control group

NO INTERVENTION

Gets written and oral preparation for surgery

Interventions

Pre-Operative Preparatory Virtual Reality ProgramOTHER

The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery

General Paediatric Surgery Intervention groupOrthopaedic Intervention groupUrologic Intervention group

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • The child has a hearing impairment
  • The child has neurologic disorder
  • The child requires postoperative intensive care
  • The child has previous experience of anesthesia
  • American Society of Anesthesiologists (ASA) score of III or greater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital Bern, Clinic for Pediatric Surgery

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Thoralf Randolf Liebs, PD Dr. med

    Department of Pediatric Surgery, Inselspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective randomized, controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr. med. Thoralf R. Liebs, consultant orthopaedic surgeon, pediatric orthopaedics, special orthopedic surgery

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 21, 2019

Study Start

August 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

CH(1)