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OpenTrials
Completed

NCT Number: NCT03334929

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Headset

Device

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

Primary outcomes

  1. Change in anxiety level

    Time frame: Immediately pre- and post-procedure

    Spielberger State-Trait Anxiety Inventory items measuring state anxiety. All items are rated on a 4-point scale, with higher scores indicating greater anxiety.

Secondary outcomes

  1. Change in pain score

    Time frame: Immediately pre- and post-procedure

    Participants will be asked to indicate pain score in a scale of 0-10, with higher scores indicating greater pain.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2017
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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