Virtual Reality Distraction for Anxiety Reduction During Trigger Points Procedures in Pain Medicine Clinic
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|ClinicalTrials.gov Identifier: NCT03334929|
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain Management||Device: Virtual Reality headset||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Virtual Reality Distraction for Anxiety Reduction During Trigger Points Procedures in Pain Medicine Clinic|
|Actual Study Start Date :||September 8, 2017|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||September 24, 2018|
Experimental: 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.
Device: Virtual Reality headset
The participants in this group would wear Virtual Reality headset called Oculus Gear VR during their trigger point injections.
No Intervention: control
Participants in this group will receive trigger point injections without any intervention. The trigger point injections will be performed in daily manner.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334929
|United States, California|
|University of California, Davis|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Naileshni Singh, MD||University of California, Davis|
|Principal Investigator:||Samir Sheth, MD||University of California, Davis|