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Trial Title:
Virtual Reality Headset And/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
NCT ID:
NCT06296147
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Transperineal Prostate Biopsy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Virtual Reality Headset
Description:
The interventions are for supportive care ONLY.
Arm group label:
Virtual Reality Device
Arm group label:
Virtual Reality and Aromatherapy
Intervention type:
Other
Intervention name:
Aromatherapy Patch
Description:
The interventions are for supportive care ONLY.
Arm group label:
Aromatherapy
Arm group label:
Virtual Reality and Aromatherapy
Intervention type:
Other
Intervention name:
Standard of Care
Description:
Participant will undergo a transperineal prostate biopsy.
Arm group label:
Aromatherapy
Arm group label:
Standard of Care
Arm group label:
Virtual Reality Device
Arm group label:
Virtual Reality and Aromatherapy
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.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pittsburgh Medical Center Shadyside Hospital
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Divya Natesan, BS
Email:
din15@pitt.edu
Contact backup:
Last name:
John Myrga, MD
Email:
myrgajm@upmc.edu
Contact backup:
Last name:
Bruce Jacobs, MD
Start date:
May 20, 2024
Completion date:
November 1, 2025
Lead sponsor:
Agency:
University of Pittsburgh
Agency class:
Other
Source:
University of Pittsburgh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06296147