Hematopoietic and Lymphoid Cell NeoplasmNCT04759183
Virtual Reality Experiences for Anxiety and Pain Control
A study testing Survey Administration, Virtual Reality Game and Virtual Reality Meditation in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This trial studies the impact of virtual reality experiences on anxiety before surgery and pain after surgery. The goal of this study is to examine how different virtual reality experiences may help reduce anxiety and improve pain control, which may help reduce the need for medications such as opioids. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Survey Administration, Virtual Reality Game and Virtual Reality Meditation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 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
- Adults (18 years or older and younger than 89)
- Able to consent
- English-speaking
Who cannot join
- Non-English speaking patients because the VR content is only available in English
- Have symptoms concerning for an active respiratory infection or are on contact or isolation precautions
- Any active eye discharge
- A history of seizure, epilepsy, or hypersensitivity to flashing light
- Have a history of motion sickness or vertigo
- Have active nausea or vomiting
Show all 11Show fewer
- Psychiatric conditions that may interfere with the ability to successfully participate in the study
- Have cardiac pacemakers
- Require hearing aids at all times that cannot be removed
- Have defibrillators
- Have wound dressings on the head or neck that prevent comfortable use of the VR headset
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Impact of Different Virtual Reality Experiences on Anxiety and Pain
This trial studies the impact of virtual reality experiences on anxiety before surgery and pain after surgery. The goal of this study is to examine how different virtual reality experiences may help reduce anxiety and improve pain control, which may help reduce the need for medications such as opioids.
Read the detailed description
PRIMARY OBJECTIVE:
- To measure the impact of a gaming virtual reality (VR) experience compared to a mindfulness VR experience on preoperative anxiety and postoperative pain.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in a VR intervention (Angry Birds) over 15 minutes before standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes after surgery.
ARM II: Patients participate in a VR intervention (TRIPP) over 15 minutes before standard of care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after surgery.
- Being tested
- Survey Administration, Virtual Reality Game, Virtual Reality Meditation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Ancillary studies
Virtual Reality GameProcedure or surgery
Also called VR Game
Participate in VR Game "Angry Birds"
Virtual Reality MeditationProcedure or surgery
Also called VR Meditation
Participate in VR Meditation "TRIPP"
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Angry Birds, TRIPP) | Experimental | Patients participate in a VR intervention (Angry Birds) over 15 minutes before standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes after surgery. Receives: Other: Survey Administration; Procedure: Virtual Reality Game; Procedure: Virtual Reality Meditation |
| Arm II (TRIPP, Angry Birds) | Experimental | Patients participate in a VR intervention (TRIPP) over 15 minutes before standard of care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after surgery. Receives: Other: Survey Administration; Procedure: Virtual Reality Game; Procedure: Virtual Reality Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in preoperative anxiety scores
Assessed by visual analogue scale (VAS) from 0-100mm.
Measured: Baseline up to pre surgery (estimated 1 day)
Change in postoperative pain scores
Assessed by VAS scale from 0-100mm.
Measured: Baseline after surgery up to study completion (estimated 1 day)
Secondary outcomes (4)
Change in blood pressure
mmHg
Measured: immediately before intervention, and then immediately after intervention (estimated 1 day)
Patient enjoyment of each VR experience
Likert scale (1-5). 1 represents the lowest score, and 5 represents the highest.
Measured: Up to study completion (estimated 1 day)
Change in heart rate
beats per minute (bpm)
Measured: immediately before intervention, and then immediately after intervention (estimated 1 day)
Patient desire to use VR more in their healthcare
Likert scale (1-5). 1 represents the lowest score, and 5 represents the highest.
Measured: Up to study completion (estimated 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start5 Mar 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 Hematopoietic and Lymphoid Cell NeoplasmStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Ryan Li, MD, OHSU Knight Cancer Institute
- Investigators
- Ryan J Li, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759183
- Sponsor's protocol ID
- STUDY00022194
- Other IDs
- NCI-2021-00794, STUDY00022194
- Status last verified
- Sep 2022
- First submitted
- 12 Feb 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. 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
- NCT04759183
- Acronym / sponsor ID
- STUDY00022194
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 18 Feb 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 the impact of virtual reality experiences on anxiety before surgery and pain after surgery. The goal of this study is to examine how different virtual reality experiences may help reduce anxiety and improve pain control, which may help reduce the need for medications such as opioids.
Detailed description
PRIMARY OBJECTIVE:
- To measure the impact of a gaming virtual reality (VR) experience compared to a mindfulness VR experience on preoperative anxiety and postoperative pain.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in a VR intervention (Angry Birds) over 15 minutes before standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes after surgery.
ARM II: Patients participate in a VR intervention (TRIPP) over 15 minutes before standard of care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Angry Birds, TRIPP) | Experimental | Other: Survey Administration, Procedure: Virtual Reality Game, Procedure: Virtual Reality MeditationPatients participate in a VR intervention (Angry Birds) over 15 minutes before standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes after surgery. |
| Arm II (TRIPP, Angry Birds) | Experimental | Other: Survey Administration, Procedure: Virtual Reality Game, Procedure: Virtual Reality MeditationPatients participate in a VR intervention (TRIPP) over 15 minutes before standard of care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after surgery. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18 years or older and younger than 89)
- Able to consent
- English-speaking
Key exclusion criteria (11 listed)
- Non-English speaking patients because the VR content is only available in English
- Have symptoms concerning for an active respiratory infection or are on contact or isolation precautions
- Any active eye discharge
- A history of seizure, epilepsy, or hypersensitivity to flashing light
- Have a history of motion sickness or vertigo
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 |
|---|---|---|
| Survey AdministrationAncillary studies | Other | Arm I (Angry Birds, TRIPP), Arm II (TRIPP, Angry Birds) |
| Virtual Reality GameAlso: VR GameParticipate in VR Game "Angry Birds" | Procedure or surgery | Arm I (Angry Birds, TRIPP), Arm II (TRIPP, Angry Birds) |
| Virtual Reality MeditationAlso: VR MeditationParticipate in VR Meditation "TRIPP" | Procedure or surgery | Arm I (Angry Birds, TRIPP), Arm II (TRIPP, Angry Birds) |
Primary outcome
Change in preoperative anxiety scores
Time frame: Baseline up to pre surgery (estimated 1 day)
Assessed by visual analogue scale (VAS) from 0-100mm.
Change in postoperative pain scores
Time frame: Baseline after surgery up to study completion (estimated 1 day)
Assessed by VAS scale from 0-100mm.
4 secondary outcomes
Change in blood pressure
Time frame: immediately before intervention, and then immediately after intervention (estimated 1 day)
Patient enjoyment of each VR experience
Time frame: Up to study completion (estimated 1 day)
Change in heart rate
Time frame: immediately before intervention, and then immediately after intervention (estimated 1 day)
Patient desire to use VR more in their healthcare
Time frame: Up to study completion (estimated 1 day)
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 7 Sep 2022.
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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.
Ryan J Li principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey Administration, Virtual Reality Game and Virtual Reality Meditation in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute 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 11 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 7 Sep 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 preoperative anxiety scores (time frame: Baseline up to pre surgery (estimated 1 day)). 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 7 Sep 2022.