Virtual Reality vs. Music Relaxation for Reducing Anxiety and Pain During Breast Biopsies

Jonsson Comprehensive Cancer Center

Status: Enrolling

Conditions: Breast Biopsy; Anxiety; Pain

Treatments: Other: Standard Calming Music; Other: Virtual Reality (VR) Mindful App

Study type: Interventional

Funder types: Other

Identifiers

NCT07310004

24-6080

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females aged 18 years or older.
• Scheduled for an ultrasound-guided or stereotactic breast biopsy.
• Capable of understanding and providing informed consent.

Exclusion criteria

• Individuals with a history of epilepsy, motion sickness, or severe cognitive impairment (for the VR group).
• Use of anxiolytic medication immediately prior to the biopsy.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

VR Intervention

Experimental group

Description:

Patients will wear a Virtual Reality (VR) headset during the breast biopsy. They will use the CS VR Mindful Meditation App. 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.

Treatment:

Other: Virtual Reality (VR) Mindful App

Music Intervention

Active Comparator group

Description:

Patients will listen to standard calming music during the breast biopsy from the computer/speakers in the room. 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.

Treatment:

Other: Standard Calming Music

No Intervention

No Intervention group

Description:

Patients will have no intervention and complete the breast biopsy as standard of 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.