The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures

NCT05042999 | Completed

• 1 other identifier: Pro00112215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.

Conditions

Breast Neoplasm Female

Keywords

Virtual Reality; Pain; Anxiety; Ultrasound Guided Biopsy

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 both 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

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 Goggles DEVICE

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

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent is obtained from the patient
• Females who are 18 years of age
• Patient is scheduled for preoperative ultrasound guided breast biopsy procedure

You may not qualify if:

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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Clemson University: collaborator

Study Sites (1)

Patewood Outpatient Surgery Center

Greenville, South Carolina, 29615, United States

Location

Related Publications (11)

• 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: 18487245 BACKGROUND

• 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: 26238976 BACKGROUND

• 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: 29319722 BACKGROUND

• 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: 1071419 BACKGROUND

• 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: 19272275 BACKGROUND

• 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: 20691523 BACKGROUND

• 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: 26696461 RESULT

• 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: 6226917 RESULT

• 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: 30322793 RESULT

• 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: 25102532 RESULT

• 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: 24892198 RESULT

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Drew Epling

  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: September 3, 2021
• First Posted: September 13, 2021
• Study Start: September 15, 2021
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)