SurgeryPPVRPNCT03957525
Pediatric Preoperative Virtual Reality Program
A study testing Pre-Operative Preparatory Virtual Reality Program in people with Surgery and Anxiety, run by Thoralf Liebs at 1 site in Switzerland.
Trial 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? Read more about this study
- Who is it for?
- Ages 7 to 13 years
- What is being tested?
- Pre-Operative Preparatory Virtual Reality Program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital Bern, Clinic for Pediatric Surgery
Bern, 3010
About this study
Official title: The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
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?
Read the 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.
- Being tested
- Pre-Operative Preparatory Virtual Reality Program
- Keywords
- Virtual reality, Pediatric, Anxiety, Surgery, Anesthesia, Intervention, Exposure, Randomized controlled trial, Pediatric urology, Orthopedic surgery, General Pediatric surgery, Pediatric orthopedics
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Pre-Operative Preparatory Virtual Reality Program |
| General Paediatric Surgery Control group | No intervention | Gets written and oral preparation for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 - 90 days after recruiting
Secondary outcomes (4)
Perioperative anxiety level of Children VAS-A
Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A.
Measured: 2 - 90 days after recruiting
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")
Measured: 2 - 90 days after recruiting
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
Measured: 14 - 110 days after recruiting
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.
Measured: 14 - 110 days after recruiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Aug 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Recruiting process could not be completed; lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized, controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thoralf Liebs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thoralf Liebs, Insel Gruppe AG, University Hospital Bern
- Investigators
- Thoralf Randolf Liebs, PD Dr. med, Principal investigator, Department of Pediatric Surgery, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957525
- Sponsor's protocol ID
- 2019-00081
- Other IDs
- 2019
- Acronym
- PPVRP
- Status last verified
- Apr 2020
- First submitted
- 17 May 2019
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT03957525
- Acronym / sponsor ID
- PPVRP / 2019-00081
- Keywords
- Virtual reality, Pediatric, Anxiety, Surgery, Anesthesia, Intervention, Exposure, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting process could not be completed; lack of participants
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Thoralf LiebsUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Prospective randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Orthopaedic Intervention group | Experimental | Other: Pre-Operative Preparatory Virtual Reality ProgramIn 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. |
| Orthopaedic Control group | No intervention | –Gets written and oral preparation for surgery |
| Urologic Intervention group | Experimental | Other: Pre-Operative Preparatory Virtual Reality ProgramIn 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. |
| Urologic Control group | No intervention | –Gets written and oral preparation for surgery |
| General Paediatric Surgery Intervention group | Experimental | Other: Pre-Operative Preparatory Virtual Reality ProgramIn 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. |
| General Paediatric Surgery Control group | No intervention | –Gets written and oral preparation for surgery |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Operative Preparatory Virtual Reality ProgramThe Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery | Other | General Paediatric Surgery Intervention group, Orthopaedic Intervention group, Urologic Intervention group |
Primary outcome
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.
4 secondary outcomes
Perioperative anxiety level of Children VAS-A
Time frame: 2 - 90 days after recruiting
Perioperative anxiety level of Children VFAS
Time frame: 2 - 90 days after recruiting
Perioperative anxiety level of accompanying parent
Time frame: 14 - 110 days after recruiting
Non-disease specific secondary Outcomes
Time frame: 14 - 110 days after recruiting
Results and safety
The study was stopped early (reason given: Recruiting process could not be completed; lack of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thoralf Randolf Liebs, PD Dr. med principal investigator
Department of Pediatric Surgery, Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Operative Preparatory Virtual Reality Program in people with Surgery and Anxiety, run by Thoralf Liebs at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting process could not be completed; lack of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative anxiety level of children immediately before surgery (VAS-A) (time frame: 2 - 90 days after recruiting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.