AnxietyNCT05744336
Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
A study testing Group 1 Immersive Virtual Reality (VR) in people with Anxiety, run by Northwestern University at 1 site in United States.
Trial summary
Periprocedural anxiety is a common problem for patients who undergo interventional pain procedures. Virtual Reality (VR) is an immersive experience that has gained acceptance in the medical field as a tool for reducing anxiety and pain for patients.Research Aim: To evaluate the effect of immersive virtual reality (VR)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Group 1 Immersive Virtual Reality (VR)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18-80 years old at day of enrollment
- Neck pain patient deemed to be a candidate for pain control treatment with interventional fluoroscopically guided cervical epidural steroid injection as determined by their pain medicine provider based on history, physical exam, and radiographic findings
- Willingness to undergo pre-procedural intervention of VR viewing experience or equivalent pre-procedural wait time
- No history of prior epidural steroid injections
- Did not receive sedatives prior to or during procedure
Who cannot join
- Refusal / inability to participate or provide consent
- Contraindications to injection (anticoagulated states, allergy to components of injection, local infection at injection site, current infectious process or treatment of antibiotics for current infection)
- Uncontrolled anxiety disorder or untreated/inadequately treated psychiatric disorder
- History of Alzheimer's, dementia, or cognitive dysfunction
- Patient currently taking benzodiazepines
- Severe motion sickness
Show all 9Show fewer
- Seizure disorder
- Vision loss
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Anesthesiology Pain Medicine Center
Chicago, Illinois, 60611
Paul Fitzgerald, 312-695-1064, p-fitzgerald2@northwestern.edu
About this study
Official title: Assessing the Impact of Immersive Virtual Reality Experience on Injection-related Anxiety in Patients Undergoing Interventional Pain Spine Procedures: a Prospective Randomized Trial
Periprocedural anxiety is a common problem for patients who undergo interventional pain procedures. Virtual Reality (VR) is an immersive experience that has gained acceptance in the medical field as a tool for reducing anxiety and pain for patients.Research Aim:
To evaluate the effect of immersive virtual reality (VR) on periprocedural anxiety related to therapeutic cervical epidural steroid injections (ESI).
The investigators hypothesize that immersive virtual reality will result in a clinically meaningful anxiety reduction, defined as the proportion of participants with > 50% reduction in Numeric Rating Scale (NRS) anxiety scores when compared to participants in the non-treatment group who will have standard preprocedural waiting time conditions in clinic, but no VR experience. Similarly, the investigators hypothesize a significant reduction in objective sympathetic tone as measured by skin sympathetic nerve activity (SKNA).
- Conditions
- Anxiety
- Being tested
- Group 1 Immersive Virtual Reality (VR), Group 2 Control Group
- Keywords
- Anxiety, Pain Procedures, Virtual Reality
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 Immersive Virtual Reality (VR)Other
Participants in Group 1 Immersive Virtual Reality (VR) participants wear the device covering their eyes. The viewing experience will include calming nature sounds for between 15-20 minutes before their planned plain clinic procedure
Group 2 Control GroupOther
Group 2 control group participants have no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Immersive Virtual Reality (VR) | Experimental | Participants in Group 1 Immersive Virtual Reality (VR) will wear the device covering their eyes. The viewing experience will include calming nature sounds for between 15-20 minutes before their planned plain clinic procedure. Receives: Other: Group 1 Immersive Virtual Reality (VR) |
| Group 2 control group | Placebo comparator | Group 2 control group has no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure. Receives: Other: Group 2 Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating score for anxiety while positioning on the fluoroscopy table.
Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) when positioning on the fluroscopy table.
Measured: Before planned procedure
Numeric rating score for anxiety when local anesthetic is injected.
Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) when local is injected.
Measured: Start of planned procedure
Numeric rating score for anxiety when the epidural needle is removed.
Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) after the epidural needle is removed
Measured: End of planned procedure
Secondary outcomes (2)
Procedural pain during epidural steroid injection reported by participants.
NRS Level of subjective procedural pain during epidural steroid injection recorded by numeric rating score on a scale of 0 (no pain) to 10 (worst pain imaginable) Level of subjective procedural pain during epidural steroid injection recorded by NRS
Measured: During planned procedure
Timepoint at peak of numeric rating score anxiety rating
Timepoint at peak numeric rating score for anxiety (NRS) 0 (no anxitey) to 10 (worst anxiety).
Measured: Through study completion average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start12 Mar 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled observational trial
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Ross, Northwestern University
- Investigators
- Jason Ross, MD, Principal investigator, Northwestern Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744336
- Sponsor's protocol ID
- STU00218462
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Immersive Virtual Reality Experience on Injection-related Anxiety in Patients Undergoing Interventional Pain Spine Procedures: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05744336
- Acronym / sponsor ID
- STU00218462
- Conditions
- Anxiety
- Keywords
- Anxiety, Pain Procedures, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 27 Feb 2023 (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.
Periprocedural anxiety is a common problem for patients who undergo interventional pain procedures. Virtual Reality (VR) is an immersive experience that has gained acceptance in the medical field as a tool for reducing anxiety and pain for patients.Research Aim:
To evaluate the effect of immersive virtual reality (VR) on periprocedural anxiety related to therapeutic cervical epidural steroid injections (ESI).
The investigators hypothesize that immersive virtual reality will result in a clinically meaningful anxiety reduction, defined as the proportion of participants with > 50% reduction in Numeric Rating Scale (NRS) anxiety scores when compared to participants in the non-treatment group who will have standard preprocedural waiting time conditions in clinic, but no VR experience. Similarly, the investigators hypothesize a significant reduction in objective sympathetic tone as measured by skin sympathetic nerve activity (SKNA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled observational trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 Immersive Virtual Reality (VR) | Experimental | Other: Group 1 Immersive Virtual Reality (VR)Participants in Group 1 Immersive Virtual Reality (VR) will wear the device covering their eyes. The viewing experience will include calming nature sounds for between 15-20 minutes before their planned plain clinic procedure. |
| Group 2 control group | Placebo comparator | Other: Group 2 Control GroupGroup 2 control group has no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years old at day of enrollment
- Neck pain patient deemed to be a candidate for pain control treatment with interventional fluoroscopically guided cervical epidural steroid injection as determined by their pain medicine provider based on history, physical exam, and radiographic findings
- Willingness to undergo pre-procedural intervention of VR viewing experience or equivalent pre-procedural wait time
- No history of prior epidural steroid injections
- Did not receive sedatives prior to or during procedure
Key exclusion criteria (9 listed)
- Refusal / inability to participate or provide consent
- Contraindications to injection (anticoagulated states, allergy to components of injection, local infection at injection site, current infectious process or treatment of antibiotics for current infection)
- Uncontrolled anxiety disorder or untreated/inadequately treated psychiatric disorder
- History of Alzheimer's, dementia, or cognitive dysfunction
- Patient currently taking benzodiazepines
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 |
|---|---|---|
| Group 1 Immersive Virtual Reality (VR)Participants in Group 1 Immersive Virtual Reality (VR) participants wear the device covering their eyes. The viewing experience will include calming nature sounds for between 15-20 minutes before their planned plain clinic procedure | Other | Group 1 Immersive Virtual Reality (VR) |
| Group 2 Control GroupGroup 2 control group participants have no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure. | Other | Group 2 control group |
Primary outcome
Numeric rating score for anxiety while positioning on the fluoroscopy table.
Time frame: Before planned procedure
Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) when positioning on the fluroscopy table.
Numeric rating score for anxiety when local anesthetic is injected.
Time frame: Start of planned procedure
Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) when local is injected.
Numeric rating score for anxiety when the epidural needle is removed.
Time frame: End of planned procedure
Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) after the epidural needle is removed
2 secondary outcomes
Procedural pain during epidural steroid injection reported by participants.
Time frame: During planned procedure
Timepoint at peak of numeric rating score anxiety rating
Time frame: Through study completion average of 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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.
Jason Ross, MD principal investigator
Northwestern Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 Immersive Virtual Reality (VR) in people with Anxiety, run by Northwestern 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Oct 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Fitzgerald, RN,BSN,MS (312-695-1064, p-fitzgerald2@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating score for anxiety while positioning on the fluoroscopy table. (time frame: Before planned procedure). The study lists 3 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 29 Oct 2026.