Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group.
This is a single-center, randomized controlled trial comparing the use of a virtual reality (VR) device vs. an aromatherapy patch vs. VR+aromatherapy vs. standard of care as a non-anesthetic pain management tool during a transperineal prostate biopsy (TPBx).
208 patients who express interest in participating in the trial will be consented via Redcap. Patients will be centrally, dynamically randomized in a 1:1:1:1 ratio to one of the treatment groups or control group. There will be no subgroup stratification. The randomization will be predetermined by participant ID number. There will be a sealed envelope prepared and labeled with the participant ID that will contain the information for which treatment group a participant is assigned to. Once a participant is consented and assigned an ID, the envelope will be reopened to reveal which intervention the patient will be assigned to.
All participants will take a survey immediately following the procedure and that will conclude their participation in the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Device | Experimental | The VR device used is the Flowly biofeedback virtual headset. This device uses calming immersive virtual worlds along with breathing exercises and a heart rate monitor to guide patients through meditated breathing exercises. The Flowly app is based on a smartphone which will be purchased through the department and used by all participants. The account used is a generic account for our department. No patient information or individualized accounts will be needed. No patient information or data will be collected. |
|
| Aromatherapy | Experimental | The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience. |
|
| Virtual Reality and Aromatherapy | Experimental | This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure. |
|
| Standard of Care | Active Comparator | Participant will undergo transperineal prostate biopsy as standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Headset | Other | The interventions are for supportive care ONLY. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levels of pain, fear, and embarrassment that each group experienced before the TPBx measured using a self-reported survey that asks about experience prior to biopsy. The survey will be provided after the procedure. | This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment. | immediately after the biopsy (up to 30 minutes) |
| Levels of pain, fear, and embarrassment that each group experienced during the TPBx measured using a self-reported survey that asks about experience during the biopsy. The survey will be provided after the procedure. | This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment. | immediately after the biopsy (up to 30 minutes) |
| Levels of pain, fear, and embarrassment that each group experienced after the TPBx measured using a self-reported survey that asks about experience after to biopsy. The survey will be provided after the procedure. | This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment. | immediately after the biopsy (up to 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure. | Track number of patients approached and number of patients who sign consent. | during enrollment |
| Safety and feasibility of using a VR device or aromatherapy patch during TPBx via the proportion of procedures completed successfully with no major complications or prolongations. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Divya Natesan | Contact | (412) 692-4100 | din15@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bruce Jacobs, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center Shadyside Hospital | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aromatherapy Patch | Other | The interventions are for supportive care ONLY. |
|
| Standard of Care | Other | Participant will undergo a transperineal prostate biopsy. |
|
Track number of procedures completed successfully with no major complications or prolongations per the investigator's discretion. |
| during the biopsy procedure (up to 30 minutes) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |