Prostate Cancer
Conditions
Keywords
Transperineal Prostate Biopsy
Brief summary
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.
Detailed description
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.
Interventions
OTHERVirtual Reality Headset
The interventions are for supportive care ONLY.
OTHERAromatherapy Patch
The interventions are for supportive care ONLY.
OTHERStandard of Care
Participant will undergo a transperineal prostate biopsy.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is 18 years or older * Patient is male * Patient is due for a transperineal prostate biopsy * Patient signed and dated informed consent form on Redcap agreeing to participate in the study
Exclusion criteria
* Patient has a known psychiatric or mental illness that would impede use of the VR device or aromatherapy patch * Patient has severe hearing or vision problems that would impair use of the VR headset (under the physician's discretion) * Patient has a history of seizures or epilepsy or is on a medication that would lower the threshold for a seizure * Patient has a history of reactions to noxious odors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | immediately after the biopsy (up to 30 minutes) | This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment. |
| 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. | immediately after the biopsy (up to 30 minutes) | This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment. |
| 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. | immediately after the biopsy (up to 30 minutes) | This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure. | during enrollment | Track number of patients approached and number of patients who sign consent. |
| 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. | during the biopsy procedure (up to 30 minutes) | Track number of procedures completed successfully with no major complications or prolongations per the investigator's discretion. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBruce Jacobs, MD
University of Pittsburgh
Outcome results
None listed