VR Ultrasound Guided Breast Localization

Breast Neoplasm Female Clinical Trial

Official title:

The Use of Virtual Reality During Breast Localization Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251507
• Other study ID #: Pro00092817
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: January 7, 2022

Study information

• Verified date: April 2022
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Needle localizations for breast cancer surgery are required to identify cancerous tissue before surgery. Currently this procedure is done with or without a local anesthetic. Patients report anxiety regarding cancer and cancer-related procedures. Different types of needle localization may have different pain and anxiety based on their duration, complexity, and invasiveness. This research is designed to determine if VR simulated environment can reduce pain and anxiety.

Our aim is to study the efficacy of a virtual environment in reducing pain and procedural anxiety. It is intended for patients undergoing an ultrasound guided breast localization procedure that have had an abnormal breast biopsy. The overall aim is to discover an efficacious nonpharmacologic method to lower pain and anxiety during a standard of care procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 7, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent is obtained from the patient

• Females = 18 years of age

• Patient is schedule for preoperative ultrasound guided breast localization procedure

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Device:
• Oculus Go Virtual Reality Goggles
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.

Locations

Country	Name	City	State
United States	Prisma Health	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Clemson University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Costa WA, Monteiro MN, Queiroz JF, Gonçalves 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. — View Citation

Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. — View Citation

Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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.ja — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate	Empatica E4 watch is a wearable device that collects real-time physiological data. This wristband is equipped with photoplethysmogram sensors for computing Heart Rate (HR). Heart rate will be reported in beats per minute (bpm).	Immediate post-procedure
Other	Temperature	Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram sensor from the watch will measure temperature. Temperature will be reported in degrees Celsius.	Immediate post-procedure
Other	Blood Volume Pulse Signal	Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram sensor from the watch will measure variation of volume of arterial blood under the skin resulting from the heart cycle computing Blood Volume Pulse (BVP). Blood Volume Pulse will be measured in beats min-1.	Immediate post-procedure
Other	Galvanic Skin Response	The Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram skin electrodes from the watch will capture the Galvanic Skin Response (GSR), also named Electrodermal Activity (EDA) and Skin Conductance (SC) or the measure of the continuous variations in the electrical characteristics of the skin. GSR will be reported in units of micro-Siemens (µS).	Immediate post-procedure
Primary	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	State-Trait Anxiety Inventory (STAI: Y-6 item)	The State-Trait Anxiety Inventory uses a 4 point Likert scale to assess how much worry, tension or apprehension the subject experiences in his or her present circumstances (state anxiety) and how much anxiety represent a personality characteristic (trait anxiety). Items emphasize the frequency of particular symptoms (ranging from 1 = not at all to 4 = very much). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).	Immediate post-procedure
Secondary	Patient Satisfaction	Patients in both groups will be asked to rate their satisfaction with their procedures using a five point likert scale (ranging from 1 = definitely disagree to 5 = definitely agree).	Immediate post-procedure