Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2019-08-01
2020-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
Pre-Operative Preparatory Virtual Reality Program
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
Orthopaedic Control group
Gets written and oral preparation for surgery
No interventions assigned to this group
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.
Pre-Operative Preparatory Virtual Reality Program
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
Urologic Control group
Gets written and oral preparation for surgery
No interventions assigned to this group
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.
Pre-Operative Preparatory Virtual Reality Program
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
General Paediatric Surgery Control group
Gets written and oral preparation for surgery
No interventions assigned to this group
Interventions
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Pre-Operative Preparatory Virtual Reality Program
The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
Eligibility Criteria
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Inclusion Criteria
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
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
7 Years
13 Years
ALL
No
Sponsors
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Thoralf Liebs
OTHER
Responsible Party
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Thoralf Liebs
PD Dr. med. Thoralf R. Liebs, consultant orthopaedic surgeon, pediatric orthopaedics, special orthopedic surgery
Principal Investigators
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Thoralf Randolf Liebs, PD Dr. med
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatric Surgery, Inselspital
Locations
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Inselspital Bern, Clinic for Pediatric Surgery
Bern, , Switzerland
Countries
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Other Identifiers
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2019-00081
Identifier Type: -
Identifier Source: org_study_id
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