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

Not Applicable

Terminated

• Conditions: Pain; Breast Pain
• Interventions: Behavioral: Nature virtual reality video

• Registration Number: NCT03877094
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Study Start: 2019-07-31
• Status Verified: 2021-08
• Primary Completion: 2021-08-27
• Study Completion: 2022-04-23
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nature Virtual Reality Video	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of Discomfort and well-being	Immediately after the end of the biopsy procedure	The questionnaire contains 6 questions that must be answered using the Likert Scale (from 1 to 5).; 1. question: your perception of physical discomfort during the exam. 1 means lot of physical discomfort and 5 a lot of physical comfort.; 2. question: what was your perception of psychological discomfort during the exam. 1 means lot of psychological discomfort and 5 a lot of psychological comfort.; 3. 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.; 4. question: how much anxiety you were in relation to the exam. 1 means extremely anxious and 5 nothing anxious.; 5. question: how much anxiety you are in relation to the test result. 1 means extremely anxious and 5 nothing anxious.; 6. 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
Visual Analogic Scale for Pain	Immediately after the end of the biopsy procedure	The numerical visual analog scale from zero to ten, zero being no pain and ten the worst pain ever felt in life
The Connectedness to Nature Scale	Immediately after the end of the biopsy procedure	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.

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, Brazil