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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334929
• Other study ID #: 1088873
• Status: Completed
• Phase: N/A
• Start date: September 8, 2017
• Est. completion date: September 24, 2018

Study information

• Verified date: October 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 24, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain Management

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gerwin RD. Myofascial Trigger Point Pain Syndromes. Semin Neurol. 2016 Oct;36(5):469-473. Epub 2016 Sep 23. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety level	Spielberger State-Trait Anxiety Inventory items measuring state anxiety. All items are rated on a 4-point scale, with higher scores indicating greater anxiety.	Immediately pre- and post-procedure
Secondary	Change in pain score	Participants will be asked to indicate pain score in a scale of 0-10, with higher scores indicating greater pain.	Immediately pre- and post-procedure