NCT03334929

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

November 3, 2017

Last Update Submit

October 22, 2018

Conditions

Pain Management

Keywords

virtual realitytrigger point injections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in pain score

    Immediately pre- and post-procedure

Study Arms (2)

Virtual Reality intervention

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

Virtual Reality headsetDEVICE

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

Virtual Reality intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Related Publications (5)

  • 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.

    PMID: 27704503BACKGROUND

  • 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.

    PMID: 24338700BACKGROUND

  • 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.

    PMID: 18992040BACKGROUND

  • 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.

    PMID: 20691523BACKGROUND

  • 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.

    PMID: 24823326BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Naileshni Singh, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Samir Sheth, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

September 8, 2017

Primary Completion

August 31, 2018

Study Completion

September 24, 2018

Last Updated

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)