Pediatric Preoperative Virtual Reality Program (PPVRP)
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bern, Switzerland, 3010
- Inselspital Bern, Clinic for Pediatric Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Orthopaedic Intervention group
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.
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The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
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No Intervention: Orthopaedic Control group
Gets written and oral preparation for surgery
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Experimental: Urologic Intervention group
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.
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The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
|
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No Intervention: Urologic Control group
Gets written and oral preparation for surgery
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Experimental: General Paediatric Surgery Intervention group
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.
|
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
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No Intervention: General Paediatric Surgery Control group
Gets written and oral preparation for surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perioperative anxiety level of children immediately before surgery (VAS-A)
Time Frame: 2 - 90 days after recruiting
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perioperative anxiety level of Children VAS-A
Time Frame: 2 - 90 days after recruiting
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Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A.
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2 - 90 days after recruiting
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Perioperative anxiety level of Children VFAS
Time Frame: 2 - 90 days after recruiting
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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") |
2 - 90 days after recruiting
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Perioperative anxiety level of accompanying parent
Time Frame: 14 - 110 days after recruiting
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Perioperative anxiety level of accompanying parent measured at T0, T1 and T2 with the VAS-A and VFAS scale
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14 - 110 days after recruiting
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Non-disease specific secondary Outcomes
Time Frame: 14 - 110 days after recruiting
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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.
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14 - 110 days after recruiting
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thoralf Randolf Liebs, PD Dr. med, Department of Pediatric Surgery, Inselspital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-00081
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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