Surgical Procedure, UnspecifiedNCT05008107
Virtual Reality as a Perioperative Teaching Tool for Families
A study testing Virtual reality in people with Surgical Procedure, Unspecified and Tonsil Hypertrophy, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Commonly, families and providers have turned to internet-based resources to provide insight as to the perioperative experience. Though there is a large amount of information that is available on the internet, medical information on the internet is of highly variable quality and the information may be conflicting or… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Surgical Procedure, Unspecified, Tonsil Hypertrophy
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 27 Jul 2023
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing tonsillectomy/adenotonsillectomy ± ear tubes in the ambulatory setting
Who cannot join
- Non-English speaking (VR program is currently only offered in English)
- Inpatient
- Unable to effectively use VR (blind, severe motion sickness)
- History of procedure in the operating room within the past year
- Having a combination/additional procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Virtual Reality as a Perioperative Teaching Tool for Families: A Randomized Controlled Trial
Commonly, families and providers have turned to internet-based resources to provide insight as to the perioperative experience. Though there is a large amount of information that is available on the internet, medical information on the internet is of highly variable quality and the information may be conflicting or inaccurate. It is hard for even the savvy well-educated patient and family to navigate and sift through all the information available. Therefore, generic web-based information does not necessarily decrease patient and caregiver anxiety. As an alternative, the investigators propose an interactive teaching tool utilizing virtual reality that may provide a cost-efficient, content-rich supplement to the traditional phone or internet-based patient education. Virtual reality (VR) will be provided to families of patients undergoing ambulatory pediatric surgery. VR will provide personalized education to patients and their families about the entire continuum of the child's surgical experience. This will range from the hospital registration, the peri-operative experience, including the separation of the child from the parent in the pre-operative area and the anesthetic induction process, and the post-operative hospital ward. The virtual reality (VR) tool will also review the in-hospital post-operative recovery process. The patient will be shown this either via an oculus headset or using their own smartphone device. In addition to improving a parent's comprehension of what their child will experience, the investigators expect that the virtual reality tool may also improve patient and caregiver satisfaction with the overall perioperative experience.
- Being tested
- Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Also called VR
Using VR goggles to watch peri-operative instructional video.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Virtual reality (VR) will be provided to families of patients undergoing ambulatory pediatric surgery. VR will provide personalized education to patients and their families about the entire continuum of the child's surgical experience. This will range from the hospital registration, the peri-operative experience, including the separation of the child from the parent in the pre-operative area and the anesthetic induction process, and the post-operative hospital ward. Receives: Other: Virtual reality |
| Control | No intervention | Families will receive standard pre-operative instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pre-op Anxiety Score
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: Baseline
Parent Pre-op Anxiety Score
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: Baseline
Patient Post-op Anxiety Score
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: Immediately prior to discharge
Parent Post-op Anxiety Score
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: Immediately prior to discharge
Secondary outcomes (1)
Parent Satisfaction Score
Assessed using an adaptation of the English version of the Leiden Perioperative Patient Satisfaction questionnaire (LPPSq). This questionnaire assesses 4 domains of satisfaction: information provision, professional competence, patient-staff relationship, and service with a total of 24 questions. Questions will be scored on a 1-5 Likert scale (from completely dissatisfied to completely satisfied) with the total satisfaction score ranging from 24-120 possible points.
Measured: Immediately prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start22 Oct 2021
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittany Willer, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008107
- Sponsor's protocol ID
- STUDY00001402
- Status last verified
- Feb 2024
- First submitted
- 26 Jul 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Perioperative Teaching Tool for Families: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05008107
- Acronym / sponsor ID
- STUDY00001402
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 17 Aug 2021 (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.
Commonly, families and providers have turned to internet-based resources to provide insight as to the perioperative experience. Though there is a large amount of information that is available on the internet, medical information on the internet is of highly variable quality and the information may be conflicting or inaccurate. It is hard for even the savvy well-educated patient and family to navigate and sift through all the information available. Therefore, generic web-based information does not necessarily decrease patient and caregiver anxiety. As an alternative, the investigators propose an interactive teaching tool utilizing virtual reality that may provide a cost-efficient, content-rich supplement to the traditional phone or internet-based patient education. Virtual reality (VR) will be provided to families of patients undergoing ambulatory pediatric surgery. VR will provide personalized education to patients and their families about the entire continuum of the child's surgical experience. This will range from the hospital registration, the peri-operative experience, including the separation of the child from the parent in the pre-operative area and the anesthetic induction process, and the post-operative hospital ward. The virtual reality (VR) tool will also review the in-hospital post-operative recovery process. The patient will be shown this either via an oculus headset or using their own smartphone device. In addition to improving a parent's comprehension of what their child will experience, the investigators expect that the virtual reality tool may also improve patient and caregiver satisfaction with the overall perioperative experience.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual realityVirtual reality (VR) will be provided to families of patients undergoing ambulatory pediatric surgery. VR will provide personalized education to patients and their families about the entire continuum of the child's surgical experience. This will range from the hospital registration, the peri-operative experience, including the separation of the child from the parent in the pre-operative area and the anesthetic induction process, and the post-operative hospital ward. |
| Control | No intervention | –Families will receive standard pre-operative instructions. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children undergoing tonsillectomy/adenotonsillectomy ± ear tubes in the ambulatory setting
Key exclusion criteria (5 listed)
- Non-English speaking (VR program is currently only offered in English)
- Inpatient
- Unable to effectively use VR (blind, severe motion sickness)
- History of procedure in the operating room within the past year
- Having a combination/additional procedure
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 |
|---|---|---|
| Virtual realityAlso: VRUsing VR goggles to watch peri-operative instructional video. | Other | Virtual Reality |
Primary outcome
Patient Pre-op Anxiety Score
Time frame: Baseline
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Parent Pre-op Anxiety Score
Time frame: Baseline
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Patient Post-op Anxiety Score
Time frame: Immediately prior to discharge
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Parent Post-op Anxiety Score
Time frame: Immediately prior to discharge
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
1 secondary outcome
Parent Satisfaction Score
Time frame: Immediately prior to discharge
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 28 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Surgical Procedure, Unspecified and Tonsil Hypertrophy, run by Nationwide Children's Hospital 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 1 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 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?
Patient Pre-op Anxiety Score (time frame: Baseline). The study lists 4 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 28 Feb 2024.