Prostate CancerNCT06296147
Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
A study testing Virtual Reality Headset and Aromatherapy Patch in people with Prostate Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Virtual Reality Headset and Aromatherapy Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Randomized, Controlled Trial: Impact on Patient Experience in Patients Assigned to Virtual Reality Headset; Aromatherapy Patch; Virtual Reality + Aromatherapy; or Standard of Care for Transperineal Prostate Biopsy
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Virtual Reality Headset, Aromatherapy Patch, Standard of Care
- Keywords
- Transperineal Prostate Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetOther
The interventions are for supportive care ONLY.
Aromatherapy PatchOther
The interventions are for supportive care ONLY.
Standard of CareOther
Participant will undergo a transperineal prostate biopsy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality Headset; Other: Standard of Care |
| Aromatherapy | Experimental | The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience. Receives: Other: Aromatherapy Patch; Other: Standard of Care |
| Virtual Reality and Aromatherapy | Experimental | This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure. Receives: Other: Virtual Reality Headset; Other: Aromatherapy Patch; Other: Standard of Care |
| Standard of Care | Active comparator | Participant will undergo transperineal prostate biopsy as standard of care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: immediately after the biopsy (up to 30 minutes)
Secondary outcomes (2)
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.
Measured: 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.
Track number of procedures completed successfully with no major complications or prolongations per the investigator's discretion.
Measured: during the biopsy procedure (up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start20 May 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Jacobs, University of Pittsburgh
- Investigators
- Bruce Jacobs, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296147
- Sponsor's protocol ID
- STUDY23080006
- Status last verified
- Jan 2026
- First submitted
- 7 Feb 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial: Impact on Patient Experience in Patients Assigned to Virtual Reality Headset; Aromatherapy Patch; Virtual Reality + Aromatherapy; or Standard of Care for Transperineal Prostate Biopsy
- ClinicalTrials.gov ID
- NCT06296147
- Acronym / sponsor ID
- STUDY23080006
- Conditions
- Prostate Cancer
- Keywords
- Transperineal Prostate Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Device | Experimental | Other: Virtual Reality Headset, Other: Standard of CareThe 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 | Other: Aromatherapy Patch, Other: Standard of CareThe aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience. |
| Virtual Reality and Aromatherapy | Experimental | Other: Virtual Reality Headset, Other: Aromatherapy Patch, Other: Standard of CareThis arm will combine both the Virtual Reality arm and the aromatherapy arm procedure. |
| Standard of Care | Active comparator | Other: Standard of CareParticipant will undergo transperineal prostate biopsy as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetThe interventions are for supportive care ONLY. | Other | Virtual Reality Device, Virtual Reality and Aromatherapy |
| Aromatherapy PatchThe interventions are for supportive care ONLY. | Other | Aromatherapy, Virtual Reality and Aromatherapy |
| Standard of CareParticipant will undergo a transperineal prostate biopsy. | Other | Aromatherapy, Standard of Care, Virtual Reality Device, Virtual Reality and Aromatherapy |
Primary outcome
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
2 secondary outcomes
Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure.
Time frame: 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.
Time frame: during the biopsy procedure (up to 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Jacobs, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset and Aromatherapy Patch in people with Prostate Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: immediately after the biopsy (up to 30 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.