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

Pain Clinical Trial

— e-Nature VR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03877094
• Other study ID #: e-Nature VR
• Status: Terminated
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: April 23, 2022

Study information

• Verified date: August 2021
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 23, 2022
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Pain
• Mastodynia
• Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Leão 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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