Pain Clinical Trial
— e-Nature VROfficial title:
e-Nature VR: Evaluation of the Impact of Virtual Reality on the Perception of Pain, Discomfort, Stress and Well-being During Breast Biopsy
Verified date | August 2021 |
Source | Hospital Israelita Albert Einstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Israelita Albert Einstein | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein |
Brazil,
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
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 |
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