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Pediatric Preoperative Virtual Reality Program (PPVRP)

Primary Purpose

Surgery, Anxiety

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Pre-Operative Preparatory Virtual Reality Program
Sponsored by
Thoralf Liebs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgery focused on measuring Virtual reality, Pediatric, Anxiety, Surgery, Anesthesia, Intervention, Exposure, Randomized controlled trial, Pediatric urology, Orthopedic surgery, General Pediatric surgery, Pediatric orthopedics

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Inselspital Bern, Clinic for Pediatric Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Orthopaedic Intervention group

Orthopaedic Control group

Urologic Intervention group

Urologic Control group

General Paediatric Surgery Intervention group

General Paediatric Surgery Control group

Arm 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.

Gets written and oral preparation for surgery

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.

Gets written and oral preparation for surgery

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.

Gets written and oral preparation for surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Perioperative anxiety level of Children VAS-A
Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A.
Perioperative anxiety level of Children VFAS
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
Perioperative anxiety level of accompanying parent measured at T0, T1 and T2 with the VAS-A and VFAS scale
Non-disease specific secondary Outcomes
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.

Full Information

First Posted
May 17, 2019
Last Updated
April 16, 2020
Sponsor
Thoralf Liebs
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1. Study Identification

Unique Protocol Identification Number
NCT03957525
Brief Title
Pediatric Preoperative Virtual Reality Program
Acronym
PPVRP
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruiting process could not be completed; lack of participants
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thoralf Liebs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Anxiety
Keywords
Virtual reality, Pediatric, Anxiety, Surgery, Anesthesia, Intervention, Exposure, Randomized controlled trial, Pediatric urology, Orthopedic surgery, General Pediatric surgery, Pediatric orthopedics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized, controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orthopaedic Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Orthopaedic Control group
Arm Type
No Intervention
Arm Description
Gets written and oral preparation for surgery
Arm Title
Urologic Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Urologic Control group
Arm Type
No Intervention
Arm Description
Gets written and oral preparation for surgery
Arm Title
General Paediatric Surgery Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
General Paediatric Surgery Control group
Arm Type
No Intervention
Arm Description
Gets written and oral preparation for surgery
Intervention Type
Other
Intervention Name(s)
Pre-Operative Preparatory Virtual Reality Program
Intervention Description
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
Primary Outcome Measure Information:
Title
Perioperative anxiety level of children immediately before surgery (VAS-A)
Description
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.
Time Frame
2 - 90 days after recruiting
Secondary Outcome Measure Information:
Title
Perioperative anxiety level of Children VAS-A
Description
Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A.
Time Frame
2 - 90 days after recruiting
Title
Perioperative anxiety level of Children VFAS
Description
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")
Time Frame
2 - 90 days after recruiting
Title
Perioperative anxiety level of accompanying parent
Description
Perioperative anxiety level of accompanying parent measured at T0, T1 and T2 with the VAS-A and VFAS scale
Time Frame
14 - 110 days after recruiting
Title
Non-disease specific secondary Outcomes
Description
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.
Time Frame
14 - 110 days after recruiting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thoralf Randolf Liebs, PD Dr. med
Organizational Affiliation
Department of Pediatric Surgery, Inselspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital Bern, Clinic for Pediatric Surgery
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Pediatric Preoperative Virtual Reality Program

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