Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Group 1 Immersive Virtual Reality (VR)

Group 2 Control Group

About this trial

This is an interventional other trial for Anxiety focused on measuring Anxiety, Pain Procedures, Virtual Reality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Seizure disorder Vision loss Non-English speaking patients

Sites / Locations

Anesthesiology Pain Medicine CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1 Immersive Virtual Reality (VR)

Group 2 control group

Arm Description

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 has no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.

Outcomes

Primary Outcome Measures

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.

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.

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

Secondary Outcome Measures

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

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).

Full Information

NCT ID

NCT05744336

First Posted

February 15, 2023

Last Updated

March 31, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT05744336

Brief Title

Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 12, 2023 (Actual)

Primary Completion Date

October 31, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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) 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety

Keywords

Anxiety, Pain Procedures, Virtual Reality

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled observational trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 Immersive Virtual Reality (VR)

Arm Type

Experimental

Arm Description

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.

Arm Title

Group 2 control group

Arm Type

Placebo Comparator

Arm Description

Group 2 control group has no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.

Intervention Type

Other

Intervention Name(s)

Group 1 Immersive Virtual Reality (VR)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Group 2 Control Group

Intervention Description

Group 2 control group participants have no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.

Primary Outcome Measure Information:

Title

Numeric rating score for anxiety while positioning on the fluoroscopy table.

Description

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.

Time Frame

Before planned procedure

Title

Numeric rating score for anxiety when local anesthetic is injected.

Description

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.

Time Frame

Start of planned procedure

Title

Numeric rating score for anxiety when the epidural needle is removed.

Description

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

Time Frame

End of planned procedure

Secondary Outcome Measure Information:

Title

Procedural pain during epidural steroid injection reported by participants.

Description

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

Time Frame

During planned procedure

Title

Timepoint at peak of numeric rating score anxiety rating

Description

Timepoint at peak numeric rating score for anxiety (NRS) 0 (no anxitey) to 10 (worst anxiety).

Time Frame

Through study completion average of 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Seizure disorder Vision loss Non-English speaking patients

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Fitzgerald, RN,BSN,MS

Phone

312-695-1064

Email

p-fitzgerald2@northwestern.edu

First Name & Middle Initial & Last Name or Official Title & Degree

David Walega, MD,MSCI

Phone

312-695-5152

Email

d-walega@northwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Walega, MD, MSCI

Organizational Affiliation

Northwestern Univesity

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anesthesiology Pain Medicine Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Fitzgerald

Phone

312-695-1064

Email

p-fitzgerald2@northwestern.edu

Anxiety

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial