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

Hospital Israelita Albert Einstein

Status: Terminated

Conditions: Pain; Breast Pain

Treatments: Behavioral: Nature virtual reality video

Study type: Interventional

Funder types: Other

Identifiers

NCT03877094

e-Nature VR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Nature Virtual Reality Video

Active Comparator group

Description:

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.

Treatment:

Behavioral: Nature virtual reality video

Control group

No Intervention group

Description:

This control group will not receive an intervention.