Virtual Reality vs Music Relaxation for Breast Biopsy Anxiety and Pain

TL
AP
Overseen ByAntonia Petruse
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual reality (VR) or music can reduce anxiety and pain during a breast biopsy. Participants will join one of three groups: one using a VR meditation app (Virtual Reality Mindful App), one listening to calming music (Standard Calming Music), and one with no extra intervention. The goal is to identify which method, if any, makes the procedure less stressful and more comfortable. Women scheduled for a breast biopsy who can give consent are suitable candidates for this study. As an unphased trial, it offers participants the chance to explore innovative ways to enhance comfort during medical procedures.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use anxiety-reducing medication right before the biopsy.

What prior data suggests that these interventions are safe for reducing anxiety and pain during breast biopsies?

Research has shown that using a Virtual Reality (VR) Mindful Meditation App during procedures like breast biopsies can reduce anxiety and pain. In some studies, patients who used VR felt less anxious and experienced less pain during the procedure, indicating that VR is generally well-tolerated and does not cause significant side effects.

Similarly, listening to calming music effectively reduces anxiety in patients undergoing breast biopsies. Studies have found that music can lower anxiety levels and help patients feel more relaxed. Music is a simple and safe option, with no major side effects reported.

Both VR and music are safe options for managing anxiety and pain during medical procedures.12345

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) and music interventions to ease anxiety and pain during breast biopsies because these methods offer a fresh, non-invasive approach. Unlike traditional treatments that might rely on medications to manage pain and anxiety, VR immerses patients in a calming virtual environment using a mindful meditation app, potentially reducing stress levels through distraction and relaxation. Listening to calming music, on the other hand, uses auditory soothing to help patients feel more at ease. These approaches aim to improve patient comfort and satisfaction without the side effects associated with pharmaceuticals.

What evidence suggests that this trial's interventions could be effective for reducing anxiety and pain during breast biopsies?

This trial will compare the effectiveness of a Virtual Reality (VR) Mindful Meditation App and standard calming music in reducing anxiety and pain during breast biopsies. Research has shown that a VR Mindful Meditation App can reduce pain and anxiety during medical procedures. Studies have found that VR effectively controls pain in various situations, including for patients receiving breast cancer treatments. Similarly, music therapy has been shown to lower anxiety and pain during breast biopsies. Combined research indicates that music can significantly reduce anxiety and pain levels. Both VR and music offer simple, non-drug options to make medical experiences more comfortable.13678

Are You a Good Fit for This Trial?

This trial is for women experiencing anxiety or pain during breast biopsies. Participants should be those undergoing this procedure and willing to try either a VR mindfulness app, listen to calming music, or receive standard care as part of the study.

Inclusion Criteria

I am a woman aged 18 or older.
I am scheduled for a breast biopsy using ultrasound or stereotactic guidance.
I understand the study and can give my consent.

Exclusion Criteria

Individuals with a history of epilepsy, motion sickness, or severe cognitive impairment (for the VR group)
I took anxiety medication right before my biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants undergo breast biopsy with either VR, music relaxation, or standard care

1 day
1 visit (in-person)

Follow-up

Participants are monitored for anxiety and pain levels before and after the procedure

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Standard Calming Music
  • Virtual Reality Mindful App

Trial Overview

The study compares a Virtual Reality (VR) Mindful Meditation App against standard calming music and regular care in reducing anxiety and pain from breast biopsies. Women will be randomly placed into one of three groups to test which method is more effective.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: VR InterventionExperimental Treatment1 Intervention
Group II: No InterventionActive Control1 Intervention
Group III: Music InterventionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

Citations

Effectiveness of Music Interventions for Patients ...

Pooled analysis revealed that music interventions significantly reduced both anxiety and pain in patients undergoing biopsy. The anxiolytic ...

Is music intervention effective in reducing anxiety and pain ...

Music therapy could be an effective, simple, non-pharmacological option in relieving anxiety during breast biopsy; however, it had no effect on procedure- ...

Imaging-Guided Core-Needle Breast Biopsy

Results. The meditation and music groups reported significantly greater anxiety reduction (P values < .05) and reduced fatigue after biopsy than ...

Effect of music on anxiety and pain during ultrasound- ...

Two of these trials showed that music reduced the anxiety levels of breast biopsy patients (13, 15), whereas one study reported that music ...

Effect of music on anxiety and pain during ultrasound ...

Two of these trials showed that music reduced the anxiety levels of breast biopsy patients (13, 15), whereas one study reported that music intervention was not ...

Imaging-Guided Core-Needle Breast Biopsy: Impact of ...

Purpose. To evaluate the impact of guided meditation and music interventions on patient anxiety, pain, and fatigue during imaging-guided breast biopsy.

Is music intervention effective in reducing anxiety and pain ...

Our meta-analysis showed that Music intervention is readily effective in reducing anxiety during the breast biopsy. However, there is no ...

Guided meditation or music on headphones can decrease ...

Overall, the team found that patients who listened to meditation and music reported much less anxiety and fatigue after their biopsy than the ...