Skip to content

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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03877094
Acronym
e-Nature VR
Enrollment
24
Registered
2019-03-15
Start date
2019-07-31
Completion date
2022-04-23
Last updated
2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Pain, Pain

Keywords

pain, virtual reality, breast biopsy, environmental health, patient comfort, complementary therapies, Nurse care

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.

Interventions

BEHAVIORALNature 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

Sponsors

Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

This study has no masking

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The Connectedness to Nature ScaleImmediately after the end of the biopsy procedureThe 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.
Evaluation of Discomfort and well-beingImmediately after the end of the biopsy procedureThe 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 PainImmediately after the end of the biopsy procedureThe numerical visual analog scale from zero to ten, zero being no pain and ten the worst pain ever felt in life

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026