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

NCT ID: NCT03877094

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2022-04-23

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.

Conditions

Pain; Breast Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nature Virtual Reality Video

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.

Group Type: ACTIVE_COMPARATOR

Nature virtual reality video

Intervention Type: BEHAVIORAL

the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy

Control group

This control group will not receive an intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nature virtual reality video

the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 28241070 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

e-Nature VR

Identifier Type: -

Identifier Source: org_study_id