NCT04251507

Brief Summary

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast localization procedure (traditional wire, savi scout or a radiofrequency identification tag).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

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

First Submitted

Initial submission to the registry

January 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2022

Completed
Last Updated

September 24, 2024

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

January 29, 2020

Last Update Submit

September 20, 2024

Conditions

Breast Neoplasm Female

Keywords

Virtual RealityPainAnxietyUltrasound Guided Needle Localization

Outcome Measures

Primary Outcomes (1)

  • Subjective Pain Assessment: Visual Analog Scale

    Pain Measured with the Visual Analog Scale. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The individual will score their pain level by circling a number 0 - 10 at baseline, pre-operative, and post-operatively. The scale range includes 0-10 scales, with \< 2 =well controlled, 2 - 5: partly controlled, \> 5: uncontrolled.

    Immediate post-procedure

Secondary Outcomes (2)

  • State-Trait Anxiety Inventory (STAI: Y-6 item)

    Immediate post-procedure

  • Patient Satisfaction

    Immediate post-procedure

Other Outcomes (4)

  • Heart Rate

    Immediate post-procedure

  • Temperature

    Immediate post-procedure

  • Blood Volume Pulse Signal

    Immediate post-procedure

  • +1 more other outcomes

Study Arms (2)

Virtual Reality Goggles

EXPERIMENTAL

Patients randomized to the intervention group will undergo their procedure as standard of care but will wear the Oculus Go Goggles and experience a virtual reality simulation. The simulation is a non-interactive polar theme video.

Device: Oculus Go Virtual Reality Goggles

Control

NO INTERVENTION

Patients randomized to the control group will undergo their procedure as standard of care without the use of virtual reality goggles.

Interventions

Oculus Go Virtual Reality GogglesDEVICE

Oculus Go is a standalone portable Virtual Reality device that enables the user to immerse in different virtual environments.Non pharmacological technique to reduce pain and anxiety during a procedure.

Virtual Reality Goggles

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent is obtained from the patient
  • Females ≥ 18 years of age
  • Patient is schedule for preoperative ultrasound guided breast localization procedure

You may not qualify if:

  • Patient is scheduled for or switched to a stereotactic localization procedure
  • The patient has motion sickness
  • The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English
  • Refusal of patient to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29615, United States

Location

Related Publications (11)

  • Bloomquist EV, Ajkay N, Patil S, Collett AE, Frazier TG, Barrio AV. A Randomized Prospective Comparison of Patient-Assessed Satisfaction and Clinical Outcomes with Radioactive Seed Localization versus Wire Localization. Breast J. 2016 Mar-Apr;22(2):151-7. doi: 10.1111/tbj.12564. Epub 2015 Dec 23.

    PMID: 26696461BACKGROUND

  • Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.

    PMID: 18487245BACKGROUND

  • Chirico A, Lucidi F, De Laurentiis M, Milanese C, Napoli A, Giordano A. Virtual Reality in Health System: Beyond Entertainment. A Mini-Review on the Efficacy of VR During Cancer Treatment. J Cell Physiol. 2016 Feb;231(2):275-87. doi: 10.1002/jcp.25117.

    PMID: 26238976BACKGROUND

  • Costa WA, Monteiro MN, Queiroz JF, Goncalves AK. Pain and quality of life in breast cancer patients. Clinics (Sao Paulo). 2017 Dec;72(12):758-763. doi: 10.6061/clinics/2017(12)07.

    PMID: 29319722BACKGROUND

  • Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.

    PMID: 1071419BACKGROUND

  • Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.

    PMID: 19272275BACKGROUND

  • 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

  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PMID: 6226917BACKGROUND

  • Ratcliff CG, Prinsloo S, Chaoul A, Zepeda SG, Cannon R, Spelman A, Yang WT, Cohen L. A Randomized Controlled Trial of Brief Mindfulness Meditation for Women Undergoing Stereotactic Breast Biopsy. J Am Coll Radiol. 2019 May;16(5):691-699. doi: 10.1016/j.jacr.2018.09.009. Epub 2018 Oct 12.

    PMID: 30322793BACKGROUND

  • Walker MR, Kallingal GJ, Musser JE, Folen R, Stetz MC, Clark JY. Treatment efficacy of virtual reality distraction in the reduction of pain and anxiety during cystoscopy. Mil Med. 2014 Aug;179(8):891-6. doi: 10.7205/MILMED-D-13-00343.

    PMID: 25102532BACKGROUND

  • Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.

    PMID: 24892198BACKGROUND

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Andrea Nisonson, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 5, 2020

Study Start

January 13, 2021

Primary Completion

January 7, 2022

Study Completion

January 7, 2022

Last Updated

September 24, 2024

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)