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 study aims to compare the effectiveness of a Virtual Reality (VR) application computer simulation \[(CS) VR Mindful Meditation App')\] versus music relaxation in reducing anxiety and pain in women undergoing breast biopsies. Participants will be randomized into three groups: VR, music relaxation, or standard care. Anxiety and pain will be measured using validated scales, and an optional physiological marker may be collected to assess stress levels. Participants will also be asked about their satisfaction with the intervention received, along with procedure-specific questions.

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+