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

This study is currently recruiting participants.
Verified November 2017 by Samir Sheth, MD, University of California, Davis
Sponsor:
ClinicalTrials.gov Identifier:
NCT03334929
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Samir Sheth, MD, University of California, Davis
  Purpose
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.

Condition Intervention
Pain Management Device: Virtual Reality headset

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Virtual Reality Distraction for Anxiety Reduction During Trigger Points Procedures in Pain Medicine Clinic

Resource links provided by NLM:


Further study details as provided by Samir Sheth, MD, University of California, Davis:

Primary Outcome Measures:
  • anxiety level [ Time Frame: Approximately, it takes 30 minutes. It starts from answering the pre-procedural anxiety survey to finish answering the post-procedural anxiety survey. ]
    all patients will answer a survey named State-Trait Anxiety Inventory before their trigger points injections, and State Anxiety Inventory after their injections as well. Then we compare their change of anxiety scores, and seek if the change of scores is significantly differed among experimental group and control group.


Secondary Outcome Measures:
  • Pain score [ Time Frame: Approximately, it takes 30 minutes. ]
    before and after trigger point injections, patients will be asked to fill out their pain score in a scale of 0-10.


Estimated Enrollment: 120
Actual Study Start Date: September 8, 2017
Estimated Study Completion Date: August 31, 2018
Estimated Primary Completion Date: July 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Lingzhou Jiang, BS 9169569479 lzjiang@ucdavis.edu

Locations
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Samir Sheth, MD    916-734-5042    sjsheth@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Naileshni Singh, MD University of California, Davis
Principal Investigator: Samir Sheth, MD University of California, Davis
  More Information

Publications:
Responsible Party: Samir Sheth, MD, Assistant Professor, Pain Medicine; Co-Director of Neuromodulation, University of California, Davis
ClinicalTrials.gov Identifier: NCT03334929     History of Changes
Other Study ID Numbers: 1088873
First Submitted: November 3, 2017
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samir Sheth, MD, University of California, Davis:
virtual reality
trigger point injections

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs