e-Nature VR: Evaluation of the Impact of Virtual Reality During Breast Biopsy (e-Nature VR)

e-Nature VR: Evaluation of the Impact of Virtual Reality on the Perception of Pain, Discomfort, Stress and Well-being During Breast Biopsy

Randomized clinical trial about the evaluation of the impact of the virtual reality intervention on the experience of pain, physical and psychological discomfort, well-being and anxiety of women during breast biopsy use of nature virtual reality video.

Study Overview

• Status: Terminated
• Conditions: Pain; Breast Pain
• Intervention / Treatment: Behavioral: Nature virtual reality video

Detailed Description

Breast biopsy is one of the main tests for the diagnosis of cancer, which generates emotional distress and can be a painful procedure. Distraction has considerable efficacy among mild psychological methods for reducing pain perception. Virtual Reality is the most advanced technology of distraction, with the highest level of immersion in virtual worlds and effective results as a non-pharmacological measure in pain perception. However, audiovisual resources related to nature have not yet been investigated in this clinical setting.

This clinical trial aims to verify the impact of the virtual reality intervention on the experience of pain, physical and psychological discomfort, well-being and anxiety of women during breast biopsy; its influence on the time of the examination; the degree of recommendation of the intervention; and if the connection with nature interferes in the results obtained on the studied variables. The Immersive Reality intervention will be provided during the breast biopsy and the variables will be evaluated using Likert-type scales and pain using the Analog Virtual Scale. Our study hypothesis is that this intervention reduce the perception of pain / discomfort during the biopsy by connecting with nature, reducing anxiety, exam time, and increasing the sense of well-being.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05652 900
    • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Voluntary participation;
• Signed in the Informed Consent Form;
• Patients with clinical conditions and preserved communication function, in other words, lucid patients;
• Patients in breast biopsy procedure.

Exclusion Criteria:

• Blind patients;
• Patients without the capacity for judgment, in other words, with dementia;
• Patients who have their clinical condition changed during the breast biopsy. Patients with history of nauseas vertigo and labyrinthitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nature Virtual Reality Video; After signing the Informed Consent Form, the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy. In the end of the procedure, the patient you will receive a Ipad (specific to the study and blocked for other functions) to respond a demographic questionnaire to characterize the sample and the likerts questionnaire to measure their pain, comfort, well-being, stress and anxiety during the procedure.	Behavioral: Nature virtual reality video; the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy
NO_INTERVENTION: Control group; This control group will not receive an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Connectedness to Nature Scale	The Nature Connection Scale is used to verify the affective aspect of the person-environment relationship. It is composed of 14 items, which are answered in a scale of 5 points, ranging from 1 (I totally disagree) to 5 (I totally agree). The higher the score, the greater the individual's connection with nature.	Immediately after the end of the biopsy procedure
Evaluation of Discomfort and well-being	The questionnaire contains 6 questions that must be answered using the Likert Scale (from 1 to 5).; question: your perception of physical discomfort during the exam. 1 means lot of physical discomfort and 5 a lot of physical comfort.; question: what was your perception of psychological discomfort during the exam. 1 means lot of psychological discomfort and 5 a lot of psychological comfort.; question: how would you rate your sense of well-being during the examination.1 means total absence of well-being and 5 best well-being welfare.; question: how much anxiety you were in relation to the exam. 1 means extremely anxious and 5 nothing anxious.; question: how much anxiety you are in relation to the test result. 1 means extremely anxious and 5 nothing anxious.; question: Would you recommend this virtual reality intervention during exams that could generate some kind of discomfort? 1 means would definitely recommend and 5 would definitely not recommend	Immediately after the end of the biopsy procedure
Visual Analogic Scale for Pain	The numerical visual analog scale from zero to ten, zero being no pain and ten the worst pain ever felt in life	Immediately after the end of the biopsy procedure

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein

Publications and helpful links

General Publications

• Leao ER, Dal Fabbro DR, Oliveira RB, Santos IR, Victor ED, Aquarone RL, Andrade CB, Ribeiro VF, Oliveira RC, Friedlander R, Ferreira DS. Stress, self-esteem and well-being among female health professionals: A randomized clinical trial on the impact of a self-care intervention mediated by the senses. PLoS One. 2017 Feb 27;12(2):e0172455. doi: 10.1371/journal.pone.0172455. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 31, 2019
• Primary Completion (ACTUAL): August 27, 2021
• Study Completion (ACTUAL): April 23, 2022

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (ACTUAL): March 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pain; virtual reality; complementary therapies; patient comfort; environmental health; breast biopsy; Nurse care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia
• Other Study ID Numbers: e-Nature VR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No