AnxietyNCT03201640
VR for Preoperative Anxiety in Children
A study testing slideshow and virtual in people with Anxiety, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
All of the tools currently available for preoperative preparation of children either use a third person approach (i.e., use media whereby they watch a video or look at pictures of another child receiving an anesthetic), provide tours at some time previous to the operation date, or are shown the equipment that they… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Anxiety
- What is being tested?
- slideshow and virtual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 18 Sep 2017to 30 Apr 2019
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged between 6 -18
- ASA physical status 1-3
- Admitted for elective surgery (day case and inpatient cases)
- Cognitively normal
Who cannot join
- ASA physical status 4-5
- Non-English speaking
- Significant visual and auditory disorders not allowing them to use the technology
- Epilepsy
- Mobility problems that would make using the technology difficult or harmful to them (i.e., reduced movement of neck)
- Cognitive impairment
- Postoperative PICU care anticipated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality for Educating and Reducing Preoperative Anxiety in Children - A Randomised Control Trial
All of the tools currently available for preoperative preparation of children either use a third person approach (i.e., use media whereby they watch a video or look at pictures of another child receiving an anesthetic), provide tours at some time previous to the operation date, or are shown the equipment that they will encounter during their anesthetic. No preoperative programme currently allows the child to experience the entire chain of events from leaving the preoperative preparation area (and their parents), walking to the operating area, being initially prepared for and receiving anesthesia and recovering from anesthesia, in real time and from a first person perspective. As such the investigators are carrying out this study to assess whether virtual reality preoperative preparation is effective in reducing anxiety at induction of anesthesia.
Read the detailed description
The investigators' goal in this study is to investigate the effects of virtual reality preoperative preparation on anxiety in children at induction of anesthesia. The hypothesis is that utilisation of this novel 1st person immersive preparatory method will lead to an enhanced understanding of what will happen to the child (in addition to what the environment looks and sounds like) when they have their anesthetic. The investigators believe this enhanced understanding and preparation will lead to the reduction in anxiety levels before and during the induction of anesthesia, and will also lead to a reduction in postoperative negative behaviour disorders.
- Conditions
- Anxiety
- Being tested
- slideshow, virtual
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slideshowBehavioural
Participants will be shown a slideshow showing a child being prepared for surgery
virtualBehavioural
Participants will be shown an immersive virtual reality preparation for surgery
| Study group | Role | What they receive |
|---|---|---|
| slideshow | Other | Participant receives traditional slideshow presentation for preoperative preparation Receives: Behavioral: slideshow |
| virtual | Other | Participant receives virtual reality presentation for preoperative preparation Receives: Behavioral: virtual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety in children
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Measured: Day of surgery, immediately following consent
Change in child anxiety
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Measured: Day of surgery, immediately preceding surgery
Secondary outcomes (3)
Induction compliance
measured using the Induction Compliance Checklist
Measured: Day of surgery, immediately preceding surgery
Anesthetic requirements
measurement includes recording dose of anesthetic(s) used
Measured: Day of surgery, intra-operatively
Post-hospitalization negative behaviours
measured using the Posthospitalization Behaviour Questionnaire (PHBQ)
Measured: Two to three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start18 Sep 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clyde Matava, The Hospital for Sick Children
- Investigators
- Clyde Matava, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201640
- Sponsor's protocol ID
- 1000056779
- Status last verified
- Dec 2021
- First submitted
- 26 Jun 2017
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Educating and Reducing Preoperative Anxiety in Children - A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT03201640
- Acronym / sponsor ID
- 1000056779
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 28 Jun 2017 (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.
All of the tools currently available for preoperative preparation of children either use a third person approach (i.e., use media whereby they watch a video or look at pictures of another child receiving an anesthetic), provide tours at some time previous to the operation date, or are shown the equipment that they will encounter during their anesthetic. No preoperative programme currently allows the child to experience the entire chain of events from leaving the preoperative preparation area (and their parents), walking to the operating area, being initially prepared for and receiving anesthesia and recovering from anesthesia, in real time and from a first person perspective. As such the investigators are carrying out this study to assess whether virtual reality preoperative preparation is effective in reducing anxiety at induction of anesthesia.
Detailed description
The investigators' goal in this study is to investigate the effects of virtual reality preoperative preparation on anxiety in children at induction of anesthesia. The hypothesis is that utilisation of this novel 1st person immersive preparatory method will lead to an enhanced understanding of what will happen to the child (in addition to what the environment looks and sounds like) when they have their anesthetic. The investigators believe this enhanced understanding and preparation will lead to the reduction in anxiety levels before and during the induction of anesthesia, and will also lead to a reduction in postoperative negative behaviour disorders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| slideshow | Other | Behavioral: slideshowParticipant receives traditional slideshow presentation for preoperative preparation |
| virtual | Other | Behavioral: virtualParticipant receives virtual reality presentation for preoperative preparation |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients aged between 6 -18
- ASA physical status 1-3
- Admitted for elective surgery (day case and inpatient cases)
- Cognitively normal
Key exclusion criteria (7 listed)
- ASA physical status 4-5
- Non-English speaking
- Significant visual and auditory disorders not allowing them to use the technology
- Epilepsy
- Mobility problems that would make using the technology difficult or harmful to them (i.e., reduced movement of neck)
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 |
|---|---|---|
| slideshowParticipants will be shown a slideshow showing a child being prepared for surgery | Behavioural | slideshow |
| virtualParticipants will be shown an immersive virtual reality preparation for surgery | Behavioural | virtual |
Primary outcome
Anxiety in children
Time frame: Day of surgery, immediately following consent
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Change in child anxiety
Time frame: Day of surgery, immediately preceding surgery
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
3 secondary outcomes
Induction compliance
Time frame: Day of surgery, immediately preceding surgery
Anesthetic requirements
Time frame: Day of surgery, intra-operatively
Post-hospitalization negative behaviours
Time frame: Two to three days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Clyde Matava principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing slideshow and virtual in people with Anxiety, run by The Hospital for Sick Children at 1 site in Canada.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 17 Dec 2021. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety in children (time frame: Day of surgery, immediately following consent). The study lists 2 primary outcomes in all. 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 17 Dec 2021; AzTrials last refreshed its copy on 29 Oct 2026.