Virtual Reality vs. Music Relaxation for Reducing Anxiety and Pain During Breast Biopsies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJonsson Comprehensive Cancer Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females aged 18 years or older.
Scheduled for an ultrasound-guided or stereotactic breast biopsy.
Capable of understanding and providing informed consent.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Virtual Reality (VR) Mindful App
Other interventionPatients will wear a Virtual Reality (VR) headset and use an application called CS VR Mindful Meditation App.
Standard Calming Music
Other interventionPatients will listen to standard calming music played in the room.
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: VR InterventionExperimental treatment 1 intervention
Group B: Music InterventionActive comparator 1 intervention
Group C: No InterventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Anxiety
Pre- and post-procedure anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The scale uses a four point Likert scale ranging from "not at all" to "very much so." The score range is from 20-80 with a higher score indicating more anxiety. The change in anxiety scores (pre- to post-procedure) will be compared across the three groups (VR, music relaxation, and control).
Time frame
perioperatively/periprocedurally2
Pain Level
Pain will be measured using the Visual Analog Scale (VAS) before and after the procedure. The scale is a subjective measure where individuals mark pain intensity on a 100mm line. typically from "no pain" (0) to "wort possible pain" (100). Higher score is worse. The change in pain scores (pre- to post-procedure) will be analyzed. The
Time frame
perioperatively/periprocedurallySecondary outcomes
1
Physiological Markers
Heart Rate Variability (RR intervals) may be recorded during the biopsy as an objective marker of anxiety and stress. This will be an optional measure and will require the patient to wear either a Polar H10 Heart Rate Sensor below the breast or a Heart Rate Sensor on the arm during the procedure.
Time frame
During Biopsy2
Satisfaction Scores
For participants in the VR and music relaxation groups, a 5-point Likert scale will measure their satisfaction with the intervention. The "Intervention Satisfaction Question" asks "How satisfied were you with the intervention you received?", with 1 being "Not at all satisfied" and 5 being "Extremely satisfied". In this scale, a higher score means a better outcome. There is also the option for "I received no intervention."
Time frame
immediately after the intervention/procedure/surgerySponsors and contacts
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Source ClinicalTrials.gov