Virtual Reality Distraction for Anxiety Reduction During Trigger Points Procedures in Pain Medicine Clinic

NCT ID: NCT03334929

Last Updated: 2018-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-08

Study Completion Date

2018-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the effect of Virtual Reality (VR) as a distraction method to help those patients undergoing trigger points therapy to reduce anxiety and increase patient satisfaction. Half of the participants will wear VR gear, meanwhile the other half will be in control group, which will not wear VR headset, only the normal care.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

trigger points can cause a wide range of pain symptoms; pain in the anterior shoulder and down the arm, headache pain, back pain, hip pain, knee pain, frozen shoulder pain, and other symptoms. Local anesthetic injections and lidocaine injections are common "wet" needling treatments for trigger points injections. The proposed mechanism by which trigger points injections alleviate pain is based on mechanical disruption of the taut bands of muscle with palpation based needling. During injections, patients may feel an intensified pain and a twitch response.

Distraction has been proved to be an effective tool in pain management, and it can also be used for a variety of medical procedures. By engaging in assigned tasks, pain and anxiety are assumed to be lessened throughout the procedure, while leaving patients less occupied by pain stimuli. . An immersive virtual environment may be preferable to medications such as sedatives, due to side effects and prolonged discharge from procedure suite. Occasionally, medications may not even be available in a busy interventional pain suite. At the UCD pain clinic, we do not offer sedating medications for bedside procedures like trigger point injections. By wearing VR headset, patients may feel less tense, anxious, and painful during trigger point injections.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual Reality intervention

Participants will be wearing Virtual Reality headset called Oculus gear equipped with Samsung galaxy S7 during the trigger point injections. The VR app chosen is called Relax VR - Rest, Relaxation \& Meditation, which will provide a calm beach scene with waves and soothing musics.

Group Type EXPERIMENTAL

Virtual Reality headset

Intervention Type DEVICE

The participants in this group would wear Virtual Reality headset called Oculus Gear VR during their trigger point injections.

control

Participants in this group will receive trigger point injections without any intervention. The trigger point injections will be performed in daily manner.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Reality headset

The participants in this group would wear Virtual Reality headset called Oculus Gear VR during their trigger point injections.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged over 18 years old, who are referred to UC Davis Pain Medicine Clinic and are candidates for trigger point injections, are English speaking and can understand oral and written instructions

Exclusion Criteria

* Patients who have high risk of motion sickness, seizure disorder, visual/hearing impairment, prisoners or are pregnant are not eligible for this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Naileshni Singh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Samir Sheth, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Davis

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Gerwin RD. Myofascial Trigger Point Pain Syndromes. Semin Neurol. 2016 Oct;36(5):469-473. doi: 10.1055/s-0036-1586262. Epub 2016 Sep 23.

Reference Type BACKGROUND
PMID: 27704503 (View on PubMed)

Zhou JY, Wang D. An update on botulinum toxin A injections of trigger points for myofascial pain. Curr Pain Headache Rep. 2014 Jan;18(1):386. doi: 10.1007/s11916-013-0386-z.

Reference Type BACKGROUND
PMID: 24338700 (View on PubMed)

Scott NA, Guo B, Barton PM, Gerwin RD. Trigger point injections for chronic non-malignant musculoskeletal pain: a systematic review. Pain Med. 2009 Jan;10(1):54-69. doi: 10.1111/j.1526-4637.2008.00526.x. Epub 2008 Nov 5.

Reference Type BACKGROUND
PMID: 18992040 (View on PubMed)

Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.

Reference Type BACKGROUND
PMID: 20691523 (View on PubMed)

Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, Meredith-Neve S, Sanders J, White B, Swearingen CJ. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res. 2014 Sep-Oct;35(5):395-408. doi: 10.1097/BCR.0000000000000019.

Reference Type BACKGROUND
PMID: 24823326 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1088873

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Human Factors Analysis in VR for Burn Treatment
NCT00409552 COMPLETED PHASE1/PHASE2
Virtual Reality Pain Study
NCT05293275 UNKNOWN NA
Firsthand ID for Pain Control
NCT01823874 COMPLETED NA
Pain Control After Trauma
NCT00739076 COMPLETED NA
Virtual Reality Distraction in Pediatric Patients.
NCT06355492 NOT_YET_RECRUITING PHASE4