Virtual RealityVR-AnxietyNCT02998801
Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality
A study testing IPAD and VR Goggles in people with Virtual Reality and Anxiety, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
To construct and evaluate an immersive 3D simulation to familiarize patients with the pre-operative experience, and investigate whether A) immersive 3D virtual reality video can reduce pre-operative anxiety, and B) how this approach compares to current practice of viewing traditional educational videos. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Virtual Reality, Anxiety, Preoperative Anxiety
- What is being tested?
- IPAD and VR Goggles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to 20 Mar 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants less than 80 years old presenting to the pre-assessment clinic at Sunnybrook Health Sciences Centre
- Planned surgical procedure is 7-14 days after pre-assessment clinic visit
Who cannot join
- Inability to provide informed consent
- Unable to complete study assessments (ie: visually impaired)
Trial locations and contacts
1 site in 1 country.
About this study
To construct and evaluate an immersive 3D simulation to familiarize patients with the pre-operative experience, and investigate whether A) immersive 3D virtual reality video can reduce pre-operative anxiety, and B) how this approach compares to current practice of viewing traditional educational videos.
Read the detailed description
The prevalence of pre-operative anxiety is estimated as being as high as 80% in surgical populations. Physiologically, this may result in higher cortisol levels, which may slow down the healing and recovery process. A multitude of perioperative clinical trials have revealed that pre-operative anxiety is associated with reduced short-term postoperative recovery, increased pain scores, nause \& vomiting, sleep disturbances, surgical wound infections, increased length of stay, and cardiac complications. It has also been linked with worse functional outcomes and quality of life up to one-year after surgery.
Literature looking at factors associated with preoperative anxiety outline a general theme of the fear of the unknown that is distressing. Specifically, the most distressing events seem to be waiting to be collected for surgery, waiting outside the operating room (OR), being transferred to the OR bed and having monitors and oxygen mask applied. These moments prior to surgery are when patients are most likely to continuously ruminate over 'what comes next' and the fact of not knowing - leading to anxiety. One survey of 161 patients presenting for elective surgery inquired about factors that led to being calm prior to their procedure and found that being well informed of the pre-operative process was a critical aspect of anxiety relief. Approaches such as implementation of the pre-anesthetic clinic (PAC) and the use of videos of what to expect leading up to surgery have been implemented to address this issue but have been costly or have had mixed effects.
Virtual reality (VR) technology presents a new educational opportunity for patients in an effort to reduce pre-operative anxiety. Through immersive 3D simulation, patients can experience the journey of being prepped for surgery and transferred to the OR. A patient can learn about their pre-operative experience in a more engaging manner as opposed to passively reading, watching video or being verbally taught about it by the healthcare provider. A patient is educated by having the perception of being physically present in the pre-operative experience days or weeks prior to their OR date.
- Conditions
- Virtual Reality, Anxiety, Preoperative Anxiety
- Being tested
- IPAD, VR Goggles
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPADOther
Patients undergoing surgery will watch the video using an PAD
VR GogglesOther
Patients undergoing surgery will watch the video using goggles
| Study group | Role | What they receive |
|---|---|---|
| Watch video using IPAD | Placebo comparator | Patient will watch the educational video using an IPAD Receives: Other: IPAD |
| Watch video using VR goggles | Active comparator | Patient will watch the educational video using VR goggles Receives: Other: VR Goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety levels as measured using VAS score from baseline to the day of surgery inside the OR.
Measured: 2 weeks
Secondary outcomes (2)
Change in heart rate between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.
Measured: 2 weeks
Change in blood pressure between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fahad Alam, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998801
- Sponsor's protocol ID
- 484-2015
- Acronym
- VR-Anxiety
- Status last verified
- Apr 2017
- First submitted
- 21 Nov 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Pre-operative Anxiety With Innovative 3D Immersive Virtual Reality
- ClinicalTrials.gov ID
- NCT02998801
- Acronym / sponsor ID
- VR-Anxiety / 484-2015
- Conditions
- Virtual Reality, Anxiety, Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
To construct and evaluate an immersive 3D simulation to familiarize patients with the pre-operative experience, and investigate whether A) immersive 3D virtual reality video can reduce pre-operative anxiety, and B) how this approach compares to current practice of viewing traditional educational videos.
Detailed description
The prevalence of pre-operative anxiety is estimated as being as high as 80% in surgical populations. Physiologically, this may result in higher cortisol levels, which may slow down the healing and recovery process. A multitude of perioperative clinical trials have revealed that pre-operative anxiety is associated with reduced short-term postoperative recovery, increased pain scores, nause \& vomiting, sleep disturbances, surgical wound infections, increased length of stay, and cardiac complications. It has also been linked with worse functional outcomes and quality of life up to one-year after surgery.
Literature looking at factors associated with preoperative anxiety outline a general theme of the fear of the unknown that is distressing. Specifically, the most distressing events seem to be waiting to be collected for surgery, waiting outside the operating room (OR), being transferred to the OR bed and having monitors and oxygen mask applied. These moments prior to surgery are when patients are most likely to continuously ruminate over 'what comes next' and the fact of not knowing - leading to anxiety. One survey of 161 patients presenting for elective surgery inquired about factors that led to being calm prior to their procedure and found that being well informed of the pre-operative process was a critical aspect of anxiety relief. Approaches such as implementation of the pre-anesthetic clinic (PAC) and the use of videos of what to expect leading up to surgery have been implemented to address this issue but have been costly or have had mixed effects.
Virtual reality (VR) technology presents a new educational opportunity for patients in an effort to reduce pre-operative anxiety. Through immersive 3D simulation, patients can experience the journey of being prepped for surgery and transferred to the OR. A patient can learn about their pre-operative experience in a more engaging manner as opposed to passively reading, watching video or being verbally taught about it by the healthcare provider. A patient is educated by having the perception of being physically present in the pre-operative experience days or weeks prior to their OR date.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Watch video using IPAD | Placebo comparator | Other: IPADPatient will watch the educational video using an IPAD |
| Watch video using VR goggles | Active comparator | Other: VR GogglesPatient will watch the educational video using VR goggles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All participants less than 80 years old presenting to the pre-assessment clinic at Sunnybrook Health Sciences Centre
- Planned surgical procedure is 7-14 days after pre-assessment clinic visit
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Unable to complete study assessments (ie: visually impaired)
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 |
|---|---|---|
| IPADPatients undergoing surgery will watch the video using an PAD | Other | Watch video using IPAD |
| VR GogglesPatients undergoing surgery will watch the video using goggles | Other | Watch video using VR goggles |
Primary outcome
Change in anxiety levels as measured using VAS score from baseline to the day of surgery inside the OR.
Time frame: 2 weeks
2 secondary outcomes
Change in heart rate between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.
Time frame: 2 weeks
Change in blood pressure between patients randomized to IPAD or VR Goggles from baseline to the day of surgery inside the OR.
Time frame: 2 weeks
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 6 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Fahad Alam, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPAD and VR Goggles in people with Virtual Reality and Anxiety, run by Sunnybrook Health Sciences Centre 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 2 inclusion and 2 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 6 Apr 2017. 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. Some participants in this study may receive a placebo. 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 levels as measured using VAS score from baseline to the day of surgery inside the OR. (time frame: 2 weeks). 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 6 Apr 2017.