SurgeryNCT04828980
Utilization of Different Virtual Reality Experiences
A study testing Oculus Quest: TRIPP and Oculus Quest: Angry Birds in people with Surgery and Pain, Postoperative, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Pain, Postoperative, Anxiety
- What is being tested?
- Oculus Quest: TRIPP and Oculus Quest: Angry Birds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 25 Aug 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing head and neck surgery
- Are able to provide informed consent
Who cannot join
- Isolation precautions
- Active eye discharge
- Active nausea or vomiting
- History of seizure, epilepsy, or hypersensitivity to flashing light
- Expected to have wounds or wound care that prevent comfortable and safe use of the VR headset
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Impact of Different Virtual Reality Experiences on Anxiety and Pain
This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.
Read the detailed description
Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications.
This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.
- Conditions
- Surgery, Pain, Postoperative, Anxiety, Otolaryngological Disease
- Being tested
- Oculus Quest: TRIPP, Oculus Quest: Angry Birds
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Quest: TRIPPDevice
This is a VR experience that focuses on meditation and mindfulness
Oculus Quest: Angry BirdsDevice
This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Virtual Reality Experience | Active comparator | Patients will be provided with a mindfulness VR experience for use up to 15 minutes at bedside. Receives: Device: Oculus Quest: TRIPP |
| Gaming Virtual Reality Experience | Active comparator | Patients will be provided with an active gaming VR experience for use up to 15 minutes at bedside. Receives: Device: Oculus Quest: Angry Birds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported anxiety
Anxiety level will be obtained using a 100mm Visual Analogue Scale (VAS). Preoperative anxiety scores will be obtained prior to VR then immmediately after VR use to assess change in anxiety after each intervention. Score will range from 0 (no anxiety) to 100 (extremely anxious)
Measured: baseline, and then 15 minutes later after VR use
Change in patient-reported pain
Pain level will be obtained using a 100mm Visual Analogue Scale (VAS). Postoperative pain scores will be obtained prior to VR then immmediately after VR use to assess change in pain level after each intervention. Score will range from 0 (no pain) to 100 (worst pain imaginable)
Measured: baseline, and then 15 minutes later after VR use
Secondary outcomes (3)
Change in blood pressure
Blood pressure (mmHG) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.
Measured: baseline, and then 15 minutes later after VR use
Patient experience
Patients will complete a short survey at the completion of their participation in each VR experience evaluating their experience using a 5-point Likert scale, with responses ranging from 1 (low satisfaction) to 5 (high satisfaction)
Measured: 1 minute after use of VR
Change in heart rate
Heart rate (beats per minute [bpm]) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.
Measured: baseline, and then 15 minutes later after VR use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Feb 2021
- Primary completion11 Apr 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Li, MD, Oregon Health and Science University
- Investigators
- Ryan Li, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828980
- Sponsor's protocol ID
- 00022194
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Virtual Reality Experiences on Anxiety and Pain
- ClinicalTrials.gov ID
- NCT04828980
- Acronym / sponsor ID
- 00022194
- Conditions
- Surgery, Pain, Postoperative, Anxiety, Otolaryngological Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 2 Apr 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.
This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.
Detailed description
Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications.
This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Virtual Reality Experience | Active comparator | Device: Oculus Quest: TRIPPPatients will be provided with a mindfulness VR experience for use up to 15 minutes at bedside. |
| Gaming Virtual Reality Experience | Active comparator | Device: Oculus Quest: Angry BirdsPatients will be provided with an active gaming VR experience for use up to 15 minutes at bedside. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing head and neck surgery
- Are able to provide informed consent
Key exclusion criteria (5 listed)
- Isolation precautions
- Active eye discharge
- Active nausea or vomiting
- History of seizure, epilepsy, or hypersensitivity to flashing light
- Expected to have wounds or wound care that prevent comfortable and safe use of the VR headset
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 |
|---|---|---|
| Oculus Quest: TRIPPThis is a VR experience that focuses on meditation and mindfulness | Device | Mindfulness Virtual Reality Experience |
| Oculus Quest: Angry BirdsThis is an active gaming VR experience that utilizes controllers to aim and launch objects at targets. | Device | Gaming Virtual Reality Experience |
Primary outcome
Change in patient-reported anxiety
Time frame: baseline, and then 15 minutes later after VR use
Anxiety level will be obtained using a 100mm Visual Analogue Scale (VAS). Preoperative anxiety scores will be obtained prior to VR then immmediately after VR use to assess change in anxiety after each intervention. Score will range from 0 (no anxiety) to 100 (extremely anxious)
Change in patient-reported pain
Time frame: baseline, and then 15 minutes later after VR use
Pain level will be obtained using a 100mm Visual Analogue Scale (VAS). Postoperative pain scores will be obtained prior to VR then immmediately after VR use to assess change in pain level after each intervention. Score will range from 0 (no pain) to 100 (worst pain imaginable)
3 secondary outcomes
Change in blood pressure
Time frame: baseline, and then 15 minutes later after VR use
Patient experience
Time frame: 1 minute after use of VR
Change in heart rate
Time frame: baseline, and then 15 minutes later after VR use
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 31 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
Brain Tumor
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
RecruitingObservational study
Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma, Sinonasal Carcinoma
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
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.
Ryan Li, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Quest: TRIPP and Oculus Quest: Angry Birds in people with Surgery and Pain, Postoperative, run by Oregon Health and Science 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 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 31 Oct 2023. 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 patient-reported anxiety (time frame: baseline, and then 15 minutes later after VR use). 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?
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 31 Oct 2023.