Study 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.
e-Nature VR: Evaluation of the Impact of Virtual Reality During Breast Biopsy
e-Nature VR
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Jul 2019
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedStudy Start
First participant enrolled
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2022
CompletedMay 31, 2022
August 1, 2021
2.1 years
March 12, 2019
May 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Evaluation of Discomfort and well-being
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
Immediately after the end of the biopsy procedure
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
Study Arms (2)
Nature Virtual Reality Video
ACTIVE COMPARATORAfter 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.
Control group
NO INTERVENTIONThis control group will not receive an intervention.
Interventions
the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Israelita Albert Einstein
São Paulo, 05652 900, Brazil
Related Publications (1)
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.
PMID: 28241070BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This study has no masking
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 15, 2019
Study Start
July 31, 2019
Primary Completion
August 27, 2021
Study Completion
April 23, 2022
Last Updated
May 31, 2022
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share