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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.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nature Virtual Reality Video | Active Comparator | 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. |
|
| Control group | No Intervention | This control group will not receive an intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nature virtual reality video | Behavioral | the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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).
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | São Paulo | 05652 900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28241070 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2019 | Jul 27, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059373 | Mastodynia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study has no masking
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