Malignant NeoplasmNCT03568292
Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures
A study testing Best Practice, Laboratory Biomarker Analysis and Oculus Rift Headset in people with Malignant Neoplasm, run by University of Southern California at 1 site in United States.
Trial summary
This trial studies how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Best Practice, Laboratory Biomarker Analysis and Oculus Rift Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Mar 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been diagnosed with any cancer
- Patient is currently hospitalized and receiving treatment for a primary or secondary cancer at University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital
- Patient is undergoing a bone marrow biopsy or lumbar puncture
Who cannot join
- Inability to sign informed assent and/or consent
- Patient with an underlying diagnosis of epilepsy, dementia, Parkinson?s disease, primary central nervous system malignancy, brain metastasis, underlying inflammatory or infectious central nervous system disorder, inner ear infection, history of vertigo, baseline visual or hearing impairment, macular degeneration, untreated glaucoma, implantable medical devices or any medical condition that investigator deems contraindicated
- Patient with an underlying chronic pain disorder, anxiety disorder, depressive disorder, or other psychiatric illness unspecified
- Patient with active Clostridium difficile infection
- Patient on any acute (within last < 24 hour [hr]) or chronic pain medication (opioid, nonsteroidal anti-inflammatory drug [NSAID], steroid)
- Patient on chronic steroids > 10 mg prednisone equivalent daily or other immunosuppressant > 1 week
- Patient who is post bone marrow transplant
- Patient with a body mass index (BMI) > 35
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures
This trial studies how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of VR in patients undergoing procedural intervention.
SECONDARY OBJECTIVES:
- To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention.
EXPLORATORY OBJECTIVES:
- Explore the use of biomarkers as a tool to reflect the impact of intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo VR intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure.
ARM II: Participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).
- Conditions
- Malignant Neoplasm
- Being tested
- Best Practice, Laboratory Biomarker Analysis, Oculus Rift Headset, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Laboratory Biomarker AnalysisOther
Correlative studies
Oculus Rift HeadsetDevice
Subject wears headset for virtual reality intervention during bone marrow biopsy or lumbar puncture procedure
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Virtual Reality | Experimental | Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure. Receives: Other: Laboratory Biomarker Analysis; Device: Oculus Rift Headset; Other: Questionnaire Administration |
| Arm II: No Virtual Reality | Active comparator | Participants receive standard of care during bone marrow biopsy or lumbar puncture. Receives: Other: Best Practice; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as assessed according to a visual analog scale (VAS)
A visual analogue pain scale is a validated pain measure. A 10 centimeter horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10.
Measured: Up to 1 year
Anxiety
Will be assessed by the State-Trait Anxiety Inventory.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Why it stopped: Awaiting new cohort to open
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Virtually Strong, LLC
- Responsible party
- Sponsor
- Investigators
- Jacek Pinski, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568292
- Sponsor's protocol ID
- 0S-17-10
- Other IDs
- NCI-2018-00759, 0S-17-10, P30CA014089
- Status last verified
- May 2026
- First submitted
- 14 Jun 2018
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures
- ClinicalTrials.gov ID
- NCT03568292
- Acronym / sponsor ID
- 0S-17-10
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Awaiting new cohort to open
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Virtually Strong, LLC
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 26 Jun 2018 (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 how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of VR in patients undergoing procedural intervention.
SECONDARY OBJECTIVES:
- To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention.
EXPLORATORY OBJECTIVES:
- Explore the use of biomarkers as a tool to reflect the impact of intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo VR intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure.
ARM II: Participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Virtual Reality | Experimental | Other: Laboratory Biomarker Analysis, Device: Oculus Rift Headset, Other: Questionnaire AdministrationParticipants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure. |
| Arm II: No Virtual Reality | Active comparator | Other: Best Practice, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants receive standard of care during bone marrow biopsy or lumbar puncture. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has been diagnosed with any cancer
- Patient is currently hospitalized and receiving treatment for a primary or secondary cancer at University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital
- Patient is undergoing a bone marrow biopsy or lumbar puncture
Key exclusion criteria (8 listed)
- Inability to sign informed assent and/or consent
- Patient with an underlying diagnosis of epilepsy, dementia, Parkinson?s disease, primary central nervous system malignancy, brain metastasis, underlying inflammatory or infectious central nervous system disorder, inner ear infection, history of vertigo, baseline visual or hearing impairment, macular degeneration, untreated glaucoma, implantable medical devices or any medical condition that investigator deems contraindicated
- Patient with an underlying chronic pain disorder, anxiety disorder, depressive disorder, or other psychiatric illness unspecified
- Patient with active Clostridium difficile infection
- Patient on any acute (within last < 24 hour [hr]) or chronic pain medication (opioid, nonsteroidal anti-inflammatory drug [NSAID], steroid)
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm II: No Virtual Reality |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I: Virtual Reality, Arm II: No Virtual Reality |
| Oculus Rift HeadsetSubject wears headset for virtual reality intervention during bone marrow biopsy or lumbar puncture procedure | Device | Arm I: Virtual Reality |
| Questionnaire AdministrationAncillary studies | Other | Arm I: Virtual Reality, Arm II: No Virtual Reality |
Primary outcome
Pain as assessed according to a visual analog scale (VAS)
Time frame: Up to 1 year
A visual analogue pain scale is a validated pain measure. A 10 centimeter horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10.
Anxiety
Time frame: Up to 1 year
Will be assessed by the State-Trait Anxiety Inventory.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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.
Jacek Pinski, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Laboratory Biomarker Analysis and Oculus Rift Headset in people with Malignant Neoplasm, run by University of Southern California 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 8 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: paused, as of the sponsor's last update on 13 May 2026. 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?
Results are not available in the source record.
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?
Pain as assessed according to a visual analog scale (VAS) (time frame: Up to 1 year). 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 13 May 2026.