Anxiety StateNCT04727697
Augmented Reality Perioperative Training and Patient Satisfaction
A study testing Augmented Reality in people with Anxiety State, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how augmented reality systems can influence perioperative experience and patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety State
- What is being tested?
- Augmented Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 4 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients 18 years old or greater
- Patients who have a scheduled ambulatory procedure with University of Miami Orthopaedic providers.
Who cannot join
- Any patient not scheduled for procedures
- Minors
- Cognitively incapacitated
- Prisoners.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Outcomes, Satisfaction, and Understanding Following Orthopaedic Ambulatory Procedures Using Augmented/Virtual Reality as an Education Tool
The purpose of this study is to learn more about how augmented reality systems can influence perioperative experience and patient satisfaction.
- Conditions
- Anxiety State
- Being tested
- Augmented Reality, Standard of Care preoperative teaching and handouts
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityOther
Patients will receive the preoperative AR experience during their immediately preoperative office visit. The duration of the exposure is approximately 15 minutes.
Standard of Care preoperative teaching and handoutsOther
At preoperative appointments, patients receive verbal teaching and written handouts about day of surgery instructions and expectations.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care, preoperative teaching group | Active comparator | The participants in this group will receive the preoperative teaching and handouts as is the current standard of care. Receives: Other: Standard of Care preoperative teaching and handouts |
| Augmented Reality perioperative experiences group | Experimental | The participants in this group will receive the preoperative teaching and handouts as is the current standard of care in addition to receiving the augmented reality (AR) perioperative experience. Receives: Other: Augmented Reality; Other: Standard of Care preoperative teaching and handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety as measured by the state-trait anxiety inventory (STAI)
STAI has scores ranging from 20 to 80 with higher scores corresponding to greater levels of anxiety.
Measured: Baseline, up to 14 days
Secondary outcomes (1)
Change in comfort level as measured by perioperative comfort questionnaire
Perioperative comfort questionnaire ranges from 1-5 with higher scores indicating greater levels of comfort.
Measured: Baseline, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start15 May 2021
- Primary completion22 Sep 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kaplan, University of Miami
- Investigators
- Lee Kaplan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727697
- Sponsor's protocol ID
- 20201439
- Status last verified
- Nov 2022
- First submitted
- 22 Jan 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rizzo MG Jr, Costello JP 2nd, Luxenburg D, Cohen JL, Alberti N, Kaplan LD. Augmented Reality for Perioperative Anxiety in Patients Undergoing Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329310. doi: 10.1001/jamanetworkopen.2023.29310.
PubMed 37589975
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes, Satisfaction, and Understanding Following Orthopaedic Ambulatory Procedures Using Augmented/Virtual Reality as an Education Tool
- ClinicalTrials.gov ID
- NCT04727697
- Acronym / sponsor ID
- 20201439
- Conditions
- Anxiety State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 27 Jan 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.
The purpose of this study is to learn more about how augmented reality systems can influence perioperative experience and patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care, preoperative teaching group | Active comparator | Other: Standard of Care preoperative teaching and handoutsThe participants in this group will receive the preoperative teaching and handouts as is the current standard of care. |
| Augmented Reality perioperative experiences group | Experimental | Other: Augmented Reality, Other: Standard of Care preoperative teaching and handoutsThe participants in this group will receive the preoperative teaching and handouts as is the current standard of care in addition to receiving the augmented reality (AR) perioperative experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients 18 years old or greater
- Patients who have a scheduled ambulatory procedure with University of Miami Orthopaedic providers.
Key exclusion criteria (5 listed)
- Any patient not scheduled for procedures
- Minors
- Cognitively incapacitated
- Prisoners.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
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 |
|---|---|---|
| Augmented RealityPatients will receive the preoperative AR experience during their immediately preoperative office visit. The duration of the exposure is approximately 15 minutes. | Other | Augmented Reality perioperative experiences group |
| Standard of Care preoperative teaching and handoutsAt preoperative appointments, patients receive verbal teaching and written handouts about day of surgery instructions and expectations. | Other | Augmented Reality perioperative experiences group, Standard of Care, preoperative teaching group |
Primary outcome
Change in Anxiety as measured by the state-trait anxiety inventory (STAI)
Time frame: Baseline, up to 14 days
STAI has scores ranging from 20 to 80 with higher scores corresponding to greater levels of anxiety.
1 secondary outcome
Change in comfort level as measured by perioperative comfort questionnaire
Time frame: Baseline, up to 14 days
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 8 Nov 2022.
- Derived from this study: PubMed 37589975Rizzo MG Jr, Costello JP 2nd, Luxenburg D, Cohen JL, Alberti N, Kaplan LD. Augmented Reality for Perioperative Anxiety in Patients Undergoing Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329310. doi: 10.1001/jamanetworkopen.2023.29310.
- 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.
Lee Kaplan, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality in people with Anxiety State, run by University of Miami 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 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 8 Nov 2022. 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?
Change in Anxiety as measured by the state-trait anxiety inventory (STAI) (time frame: Baseline, up to 14 days). 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 NCT04727697, 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 Nov 2022.