AnxietyNCT03583450
Perioperative Virtual Reality for Pediatric Anesthesia
A study testing Perioperative virtual reality headset with mobile app in people with Anxiety, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Perioperative virtual reality headset with mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 27 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 5-12 years
- Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure
Who cannot join
- Patients with injuries to the head/face that would prohibit wearing of headsets
- Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
- Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
- Patients with a history of or current symptoms of vertigo
- Patients who are blind
- Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
- Patients on whom the VR headset does not fit appropriately
- Non-English speaking patients (due to limited availability of non-English study documents and consents)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital
San Francisco, California, 94158
About this study
Official title: Perioperative Virtual Reality for Pediatric Anesthesia: Pediatric Distraction on Induction With Virtual Reality (PEDI-VR)
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.
Read the detailed description
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial. We will be enrolling patients age 5-12 years presenting for elective surgery.
Patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.
- Conditions
- Anxiety
- Being tested
- Perioperative virtual reality headset with mobile app
- Keywords
- Virtual Reality, Pediatric Anesthesia
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative virtual reality headset with mobile appDevice
Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
| Study group | Role | What they receive |
|---|---|---|
| Perioperative virtual reality headset | Experimental | Perioperative virtual reality headset with mobile app and routine anesthetic care Receives: Device: Perioperative virtual reality headset with mobile app |
| Control | No intervention | Routine anesthetic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Pediatric Anxiety (Change From Baseline)
Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)
Measured: (Day 0 + 15 minutes on average from initial baseline) On entering the OR
Perioperative Pediatric Anxiety (Change From Baseline)
Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)
Measured: (Day 0 + 30 minutes on average from initial baseline) During mask induction
Secondary outcomes (3)
Perioperative Parental Anxiety (Change From Baseline)
State-Trait Anxiety Inventory: Self-reported anxiety instrument containing two separate 2-item subscales that measure trait (baseline) and state (situational) anxiety. Total range 20 to 80 with higher scores indicating greater anxiety. The value is a sum of trait and state anxiety.
Measured: (Day 0 + 45 minutes on average from initial baseline) After mask induction
Induction Compliance Checklist
Induction Compliance Checklist (An observational scale used to describe the compliance of a child during induction of anesthesia, range 0 to 11 with higher scores indicating less compliance)
Measured: (Day 0 + 30 minutes on average from initial baseline) During mask induction
Parental Satisfaction
21-item parental satisfaction questionnaire after induction of general anesthesia (T3). Parental satisfaction score range: 21-84. Higher scores represent higher satisfaction.
Measured: (Day 0 + 45 minutes on average from initial baseline) After mask induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start29 Aug 2018
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Jung, Principal investigator, UCSF Medical CenterJina Sinskey, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583450
- Sponsor's protocol ID
- 18-25277
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2018
- Last updated
- 8 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.
PubMed 32618627
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Virtual Reality for Pediatric Anesthesia: Pediatric Distraction on Induction With Virtual Reality (PEDI-VR)
- ClinicalTrials.gov ID
- NCT03583450
- Acronym / sponsor ID
- 18-25277
- Conditions
- Anxiety
- Keywords
- Virtual Reality, Pediatric Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Posted 8 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.
Detailed description
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial. We will be enrolling patients age 5-12 years presenting for elective surgery.
Patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative virtual reality headset | Experimental | Device: Perioperative virtual reality headset with mobile appPerioperative virtual reality headset with mobile app and routine anesthetic care |
| Control | No intervention | –Routine anesthetic care |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 5-12 years
- Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure
Key exclusion criteria (8 listed)
- Patients with injuries to the head/face that would prohibit wearing of headsets
- Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
- Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
- Patients with a history of or current symptoms of vertigo
- Patients who are blind
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 |
|---|---|---|
| Perioperative virtual reality headset with mobile appPerioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software) | Device | Perioperative virtual reality headset |
Primary outcome
Perioperative Pediatric Anxiety (Change From Baseline)
Time frame: (Day 0 + 15 minutes on average from initial baseline) On entering the OR
Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)
Perioperative Pediatric Anxiety (Change From Baseline)
Time frame: (Day 0 + 30 minutes on average from initial baseline) During mask induction
Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)
3 secondary outcomes
Perioperative Parental Anxiety (Change From Baseline)
Time frame: (Day 0 + 45 minutes on average from initial baseline) After mask induction
Induction Compliance Checklist
Time frame: (Day 0 + 30 minutes on average from initial baseline) During mask induction
Parental Satisfaction
Time frame: (Day 0 + 45 minutes on average from initial baseline) After mask induction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32618627Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.
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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.
Michael Jung principal investigator
UCSF Medical Center
Jina Sinskey, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative virtual reality headset with mobile app in people with Anxiety, run by University of California, San Francisco at 1 site in United States.
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 2 inclusion and 8 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 8 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Pediatric Anxiety (Change From Baseline) (time frame: (Day 0 + 15 minutes on average from initial baseline) On entering the OR). 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?
On the ClinicalTrials.gov record for NCT03583450, which also lists 1 linked publication.
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 8 Jul 2020.