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

Primary Purpose

Pain, Breast Pain

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nature virtual reality video
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring pain, virtual reality, breast biopsy, environmental health, patient comfort, complementary therapies, Nurse care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Nature Virtual Reality Video

Control group

Arm Description

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.

This control group will not receive an intervention.

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

Full Information

First Posted
March 12, 2019
Last Updated
May 25, 2022
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT03877094
Brief Title
e-Nature VR: Evaluation of the Impact of Virtual Reality During Breast Biopsy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
April 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Breast Pain
Keywords
pain, virtual reality, breast biopsy, environmental health, patient comfort, complementary therapies, Nurse care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
This study has no masking
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nature Virtual Reality Video
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This control group will not receive an intervention.
Intervention Type
Behavioral
Intervention Name(s)
Nature virtual reality video
Intervention Description
the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy
Primary Outcome Measure Information:
Title
The Connectedness to Nature Scale
Description
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.
Time Frame
Immediately after the end of the biopsy procedure
Title
Evaluation of Discomfort and well-being
Description
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
Time Frame
Immediately after the end of the biopsy procedure
Title
Visual Analogic Scale for Pain
Description
The numerical visual analog scale from zero to ten, zero being no pain and ten the worst pain ever felt in life
Time Frame
Immediately after the end of the biopsy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05652 900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28241070
Citation
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.
Results Reference
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e-Nature VR: Evaluation of the Impact of Virtual Reality During Breast Biopsy

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