Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-31 @ 10:27 PM
Study NCT ID:
NCT03877094
Status:
TERMINATED
Last Update Posted:
2022-05-31
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
e-Nature VR: Evaluation of the Impact of Virtual Reality During Breast Biopsy
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to restrictions imposed by the COVID-19 pandemic and difficulty of partcipants' adhesion, we chose to stop the data collection and suspend the project.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
e-Nature VR
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: