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Virtual RealityNCT04125004

Use of Virtual Reality for Pediatric Minor Surgical Procedures

A study testing Samsung Virtual Reality Headset in people with Virtual Reality and General Anesthesia, run by Stanford University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This project is looking to use virtual reality for minor general surgery procedures in addition to local anesthesia instead of general anesthesia. Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Virtual Reality, General Anesthesia
What is being tested?
Samsung Virtual Reality Headset
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
8 Jan 2020to 1 Mar 2021
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 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • less than 18 years of age
  • parental consent/patient assent
  • undergoing minor procedure(s)

Who cannot join

  • participants and patients who do not consent
  • have significant cognitive impairment
  • have a history of severe motion sickness
  • currently have nausea
  • history of seizures or currently experiencing seizures
  • have visual or auditory impairment
Show all 12Show fewer
  • clinically unstable or require urgent/emergent intervention and/or American Society of Anesthesiologist class 4 or 5
  • history of claustrophobia
  • Glasgow Coma Scale <15
  • currently taking anxiety medication
  • currently taking narcotics
  • facial trauma

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94305

Other trials in United States

About this study

Official title: Evaluation of Technology-Based Distractions In Pediatric Patients During General Surgery Minor Procedures

This project is looking to use virtual reality for minor general surgery procedures in addition to local anesthesia instead of general anesthesia.

Read the detailed description

Study population. Patients ages 7-18 undergoing minor surgical procedures at Lucile Packard Children's Hospital will be recruited. Minor surgical procedures include hormone implant placement/removal/exchange, cecostomy tube exchange, incision and drainage of superficial soft tissue abscesses excluding the perineum and buttock, excision of benign masses <2cm on the extremity (e.g. sebaceous cyst, pilomatricoma, lipoma, etc), and foreign body removal from superficial wounds. Exclusion criteria include those with significant cognitive impairment, history of motion sickness, history of seizures, Glasgow Coma Scale (GCS) <15, currently taking anxiety medication or narcotics, facial trauma, clinically unstable or require urgent/emergent intubation, claustrophobia, and visual or auditory impairment. The investigators aim to enroll at least 200 patients into the study.

Intervention. Research coordinators will recruit patients and their families prior to their schedule procedures. Informed consent and assent will be obtained from participants and their caregivers when a patient is a minor. Demographic information will be collected from all participants. Patients will complete pre-procedural survey for pain and anxiety. Parents will complete a survey that documents their perception of their child's anxiety level. Patients will be randomly assigned to a treatment arm.

Patients assigned to the general anesthesia arm will have a child life specialist in the pre-procedural period per hospital routine. Anesthesia will be administered at the discretion of the anesthesiologist. Once the procedure is completed, the patient will recover and be monitored in the post-anesthesia care unit (PACU) per hospital guidelines.

Patients assigned to the virtual reality arm will be instructed on how to use the handheld system. A trained research coordinator or child life specialist will be with the patient during the procedure to help with any issues that may arise. They will document any interfering behaviors during the procedure. After the procedure, the patient will be monitored in the PACU per hospital guidelines.

All patients will complete the post-procedural survey for pain and anxiety. Patients, parents and the surgeon will also complete satisfaction surveys.

Being tested
Samsung Virtual Reality Headset
Keywords
virtual reality, pediatric surgery, general anesthesia, distraction technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Samsung Virtual Reality HeadsetDevice

    Patients will pick a game or feature from the virtual reality headset to use during their procedure

Study groups in NCT04125004
Study groupRoleWhat they receive
virtual realityExperimentalPatients will use virtual reality headset during procedure
Receives: Device: Samsung Virtual Reality Headset
general anesthesiaNo interventionPatients will undergo general anesthesia for their procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion of procedure

    Can the procedure be completed without general anesthesia or procedure sedation. Surgeons will be provided with a self-report survey documenting completion of the procedure. This will be assessed by the surgeon completing the procedure who will answer via questionnaire.

    Measured: 2 years

Secondary outcomes (7)

  1. Change in Children's Fear Scale

    The Children's Fear Scale (McMurty et al. 2011) is a self-reported scale that uses cartoon depictions of faces to quantify on a 0-4 scale how scared a child is at the given moment

    Measured: 2 years

  2. Pain Catastrophizing Scale for Parents

    Parents will complete a modified Pain Catastrophizing Scale for Parents (PCS-P) before and after the procedure. This survey identifies the thoughts and feelings of the parent in relation to the pain their child may experience during the procedure. Scores range from 1 (not at all) to 5 (very much).

    Measured: 2 years

  3. Change in Faces Pain Scale

    The Face Pain Scale (Hicks et. al., 2001) is a self-reported scale that uses cartoon depictions of faces to quantify on a scale 0-10 scale how pain a child is experiencing at a given moment.

    Measured: 2 years

  4. Caregiver's satisfaction of procedure

    A satisfaction survey will be provided to caregivers which will document how satisfied they were using the intervention, if they believed it helped them, if they would choose to use the intervention again and if they would recommend the intervention.

    Measured: 2 years

  5. Clinician Satisfaction Survey

    Surgeons will be provided with a self-report survey asking their satisfaction with the technology, the patients' immersion with the technology, and the desire for use in future procedures based on a 1-5 scale.

    Measured: 2 years

  6. Cost difference between general anesthesia and virtual reality

    Hospital cost data for the procedure will be collected. The difference in cost for patients using general anesthesia versus using virtual reality will then be calculated

    Measured: 2 years

  7. Change in Anxiety Scale

    Participants will fill out a survey to document their anxiety during and after the procedure. Anxiety will be measured on a visual analogue scale using the Childhood Anxiety Meter (0-10) where participants will fill in a scale of how anxious they were during and after the procedure. Higher values represent a worse outcome (i.e. higher level of anxiety).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2019
  2. Study start8 Jan 2020
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Why it stopped: Exploratory pre-study demonstrated participants unwilling to be randomized to control arm.

Resources

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
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04125004
Sponsor's protocol ID
52692
Status last verified
Mar 2021
First submitted
9 Sep 2019
Last updated
22 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

    PubMed 21806301

  • Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

    PubMed 11427329

Questions about this trial

What is this clinical trial studying?

A study testing Samsung Virtual Reality Headset in people with Virtual Reality and General Anesthesia, run by Stanford University 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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 22 Mar 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 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Completion of procedure (time frame: 2 years). 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 NCT04125004, which also lists 2 linked publications.

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 22 Mar 2021.

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