Paine-Nature VRNCT03877094
e-Nature VR: Evaluation of the Impact of Virtual Reality During Breast Biopsy
A study testing Nature virtual reality video in people with Pain and Breast Pain, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Breast Pain
- What is being tested?
- Nature virtual reality video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jul 2019to 23 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pain, Breast Pain
- Being tested
- Nature virtual reality video
- Keywords
- pain, virtual reality, breast biopsy, environmental health, patient comfort, complementary therapies, Nurse care
- Medical subject headings
- Pain, Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature virtual reality videoBehavioural
the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nature virtual reality video |
| Control group | No intervention | This control group will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
- 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
Measured: 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
Measured: Immediately after the end of the biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start31 Jul 2019
- Primary completion27 Aug 2021
- Study completion23 Apr 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877094
- Sponsor's protocol ID
- e-Nature VR
- Acronym
- e-Nature VR
- Status last verified
- Aug 2021
- First submitted
- 12 Mar 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28241070
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03877094
- Acronym / sponsor ID
- e-Nature VR / e-Nature VR
- Conditions
- Pain, Breast Pain
- Keywords
- pain, virtual reality, breast biopsy, environmental health, patient comfort, complementary therapies, Nurse care
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature Virtual Reality Video | Active comparator | Behavioral: Nature virtual reality videoAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature virtual reality videothe patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy | Behavioural | Nature Virtual Reality Video |
Primary outcome
The Connectedness to Nature Scale
Time frame: Immediately after the end of the biopsy procedure
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
Time frame: Immediately after the end of the biopsy procedure
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
Visual Analogic Scale for Pain
Time frame: Immediately after the end of the biopsy procedure
The numerical visual analog scale from zero to ten, zero being no pain and ten the worst pain ever felt in life
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 28241070Leao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature virtual reality video in people with Pain and Breast Pain, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Connectedness to Nature Scale (time frame: Immediately after the end of the biopsy procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03877094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.