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Pediatric Preoperative Virtual Reality Program (PPVRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03957525
Recruitment Status : Terminated (Recruiting process could not be completed; lack of participants)
First Posted : May 21, 2019
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Thoralf Liebs, University Hospital Inselspital, Berne

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?

Condition or disease Intervention/treatment Phase
Surgery Anxiety Other: Pre-Operative Preparatory Virtual Reality Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized, controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
Other: 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

No Intervention: Orthopaedic Control group
Gets written and oral preparation for surgery
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.
Other: 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

No Intervention: Urologic Control group
Gets written and oral preparation for surgery
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.
Other: 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

No Intervention: General Paediatric Surgery Control group
Gets written and oral preparation for surgery



Primary Outcome Measures :
  1. Perioperative anxiety level of children immediately before surgery (VAS-A) [ Time Frame: 2 - 90 days after recruiting ]

    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 :
  1. Perioperative anxiety level of Children VAS-A [ Time Frame: 2 - 90 days after recruiting ]
    Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A.

  2. Perioperative anxiety level of Children VFAS [ Time Frame: 2 - 90 days after recruiting ]

    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")


  3. Perioperative anxiety level of accompanying parent [ Time Frame: 14 - 110 days after recruiting ]
    Perioperative anxiety level of accompanying parent measured at T0, T1 and T2 with the VAS-A and VFAS scale

  4. Non-disease specific secondary Outcomes [ Time Frame: 14 - 110 days after recruiting ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957525


Locations
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Switzerland
Inselspital Bern, Clinic for Pediatric Surgery
Bern, Switzerland, 3010
Sponsors and Collaborators
Thoralf Liebs
Investigators
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Principal Investigator: Thoralf Randolf Liebs, PD Dr. med Department of Pediatric Surgery, Inselspital
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Responsible Party: Thoralf Liebs, PD Dr. med. Thoralf R. Liebs, consultant orthopaedic surgeon, pediatric orthopaedics, special orthopedic surgery, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03957525    
Other Study ID Numbers: 2019-00081
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thoralf Liebs, University Hospital Inselspital, Berne:
Virtual reality
Pediatric
Anxiety
Surgery
Anesthesia
Intervention
Exposure
Randomized controlled trial
Pediatric urology
Orthopedic surgery
General Pediatric surgery
Pediatric orthopedics
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders