Westwood
Los Angeles, California, 90095, United States
Location status: Recruiting
NCT Number: NCT07310004
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Los Angeles, California, 90095, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will wear a Virtual Reality (VR) headset and use an application called CS VR Mindful Meditation App.
Patients will listen to standard calming music played in the room.
Time frame: perioperatively/periprocedurally
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/periprocedurally
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: During Biopsy
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: immediately after the intervention/procedure/surgery
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."
Contact information is provided by the study sponsor or research team.
Jonsson Comprehensive Cancer Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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