Virtual Reality and Aromatherapy for Prostate Cancer Biopsy

Overseen By Divya Natesan

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Seizure medications

Disqualifiers: Psychiatric illness, Hearing problems, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

208 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on medication that lowers the threshold for seizures, you may not be eligible to participate.

What data supports the idea that Virtual Reality and Aromatherapy for Prostate Cancer Biopsy is an effective treatment?

The available research does not provide any data specifically supporting the effectiveness of Virtual Reality and Aromatherapy for Prostate Cancer Biopsy. The studies listed focus on other treatments for prostate cancer, such as androgen-deprivation therapy and radiotherapy, and do not mention Virtual Reality or Aromatherapy. Therefore, there is no direct evidence from these studies to support the effectiveness of Virtual Reality and Aromatherapy for this condition. ^{1 2 3 4 5}

Is virtual reality therapy safe for use in medical procedures?

Research suggests that virtual reality therapy is generally safe for use in medical procedures, as it has been used to help reduce pain and anxiety in cancer-related procedures and anxiety disorders without significant safety concerns. ^{6 7 8 9 10}

How does the treatment of Virtual Reality and Aromatherapy for Prostate Cancer Biopsy differ from other treatments?

This treatment is unique because it combines virtual reality, which can provide a calming and immersive experience, with aromatherapy, which uses essential oils to potentially reduce stress and improve mood. Unlike traditional medical treatments for prostate cancer, this approach focuses on enhancing the patient's comfort and emotional well-being during the biopsy procedure. ^{11 12 13 14 15}

Research Team

Bruce Jacobs, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals undergoing a transperineal prostate biopsy, typically done to diagnose prostate cancer. Participants should be willing to potentially use virtual reality (VR) headsets and aromatherapy patches during the procedure. Specific eligibility criteria are not provided, but usually include age range, health status, and no prior adverse reactions to similar interventions.

Inclusion Criteria

I am 18 years old or older.

I am male.

I am scheduled for a prostate biopsy through the skin between the anus and scrotum.

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)

I have epilepsy or seizures, or I take medication that could make seizures more likely.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a transperineal prostate biopsy with either a VR headset, aromatherapy patch, both, or standard of care

1 day

1 visit (in-person)

Follow-up

Participants complete a survey immediately after the biopsy to assess pain, fear, and embarrassment

up to 30 minutes

1 visit (in-person)

Treatment Details

Interventions

• Aromatherapy
• Virtual Reality Headset

Trial Overview The study is testing whether using VR headsets and/or aromatherapy patches can help reduce pain, anxiety, and embarrassment compared to just getting the standard care during a prostate biopsy. Patients will be randomly assigned into four groups: one with VR only, one with aromatherapy only, one with both VR and aromatherapy, and a control group receiving standard care.

Participant Groups

Group I: Virtual Reality and Aromatherapy Experimental Treatment 3 Interventions

This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.

Group II: Virtual Reality Device Experimental Treatment 2 Interventions

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.

Group III: Aromatherapy Experimental Treatment 2 Interventions

The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.

Group IV: Standard of Care Active Control 1 Intervention

Participant will undergo transperineal prostate biopsy as standard of care.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Findings from Research

In a network meta-analysis of 6 trials involving 5,381 men with localized prostate cancer, the addition of androgen-deprivation therapy (ADT) to external beam radiotherapy (EBRT) significantly improved overall survival (OS) compared to EBRT alone, with a hazard ratio of 0.71.

The addition of a brachytherapy boost (BT) to EBRT did not significantly improve OS, and the analysis indicated an 88% probability that EBRT plus ADT leads to better survival outcomes than EBRT plus BT, suggesting that ADT should be included in treatment plans for men with intermediate- and high-risk prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of Androgen-Deprivation Therapy or Brachytherapy Boost to External Beam Radiotherapy for Localized Prostate Cancer: A Network Meta-Analysis of Randomized Trials. Jackson, WC., Hartman, HE., Dess, RT., et al.[2022]

In a meta-analysis of 12 trials involving 10,853 patients, the addition of androgen deprivation therapy (ADT) to radiotherapy significantly improved metastasis-free survival in men with localized prostate cancer, with a hazard ratio of 0.83, indicating a 17% reduction in the risk of metastasis.

Prolonging adjuvant ADT after radiotherapy also enhanced metastasis-free survival (HR 0.84), while extending neoadjuvant ADT did not show a significant benefit, suggesting that timing and duration of ADT are critical factors in treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy use and duration with definitive radiotherapy for localised prostate cancer: an individual patient data meta-analysis. Kishan, AU., Sun, Y., Hartman, H., et al.[2022]

In a randomized trial involving 1,205 men with locally advanced prostate cancer, the addition of radiotherapy (RT) to androgen-deprivation therapy (ADT) significantly improved overall survival, with a hazard ratio of 0.70, indicating a 30% reduction in the risk of death compared to ADT alone.

The combination of ADT and RT also significantly reduced deaths specifically from prostate cancer (HR, 0.46), although patients receiving this combined treatment experienced more bowel-related adverse events, with only a small number reporting severe diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer. Mason, MD., Parulekar, WR., Sydes, MR., et al.[2022]

In a study of 277 patients undergoing salvage radiotherapy (sRT) after prostate surgery, starting treatment when PSA levels were ≤ 0.5 ng/mL significantly improved biochemical relapse-free survival (BC-RFS) and hormone therapy-free survival (HT-FS).

Prognostic factors such as lymphovascular invasion, higher pT-stages, and negative surgical margins were found to negatively impact BC-RFS and HT-FS, highlighting the importance of early intervention and careful monitoring of these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological stage, surgical margin and lymphovascular invasion as prognostic factors after salvage radiotherapy for post-prostatectomy relapsed prostate cancer - outcomes and optimization strategies. Rodrigues, I., Ferreira, C., Gonçalves, J., et al.[2022]

In a long-term follow-up of 1322 patients with intermediate-risk and high-risk localized prostate cancer, neoadjuvant hormonal therapy (NHT) combined with whole pelvic radiotherapy (WPRT) significantly improved progression-free survival compared to NHT with prostate-only radiotherapy (PORT) and WPRT with adjuvant hormonal therapy (AHT).

While NHT plus WPRT showed better progression-free survival rates (28.4% at 10 years), it was associated with a higher incidence of grade 3 or worse late toxicities, particularly bladder and gastrointestinal issues, indicating a need for careful consideration of treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequence of hormonal therapy and radiotherapy field size in unfavourable, localised prostate cancer (NRG/RTOG 9413): long-term results of a randomised, phase 3 trial. Roach, M., Moughan, J., Lawton, CAF., et al.[2021]

Virtual reality exposure therapy (VRET) has emerged as a promising alternative treatment for anxiety disorders, including phobias, panic disorder, and posttraumatic stress disorder, as highlighted in a systematic review of controlled trials.

The review emphasizes the importance of therapeutic factors, such as the therapeutic alliance and cognitive enhancements, which may improve the effectiveness of VRET in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy in anxiety disorders: a systematic review of process-and-outcome studies. Meyerbröker, K., Emmelkamp, PM.[2018]

Virtual Reality Exposure Therapy (VRE) and Cognitive Therapy (CT) were found to be equally effective as Cognitive-Behavior Therapy (CBT) in reducing public speaking anxiety (PSA) in a study involving subjects who received 12 therapy sessions.

While CT showed some superiority over VRE on one behavioral measure, VRE was better at reducing fear during a behavioral task, indicating that both therapies can be effective options for treating PSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure versus cognitive restructuring for treatment of public speaking anxiety: a pilot study. Wallach, HS., Safir, MP., Bar-Zvi, M.[2018]

A review of 27 randomized controlled trials (RCTs) on virtual reality exposure therapy (VRET) for anxiety disorders found that the overall quality of the studies was low, with an average adherence to only 2.85 out of 8 research design criteria.

While VRET appears to be an effective treatment option, the variability in study quality and the reduction in effect size for larger sample sizes suggest that caution is needed when interpreting the results and comparing VRET to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. McCann, RA., Armstrong, CM., Skopp, NA., et al.[2022]

A systematic review of nine studies on the use of immersive virtual reality (VR) for pain and anxiety management in cancer patients showed a trend towards improvement, but only two studies demonstrated statistically significant results.

The current evidence is inconclusive due to methodological limitations and small sample sizes, highlighting the need for further research to better understand the effectiveness of VR in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. Chow, H., Hon, J., Chua, W., et al.[2021]

In a pilot study of 23 patients undergoing prostate procedures, 74% expressed interest in using Virtual Reality Hypnosis (VRH) before the procedure, indicating a strong willingness to try this method for pain and anxiety management.

Patients who experienced higher pain and distress during the procedure were more likely to want to use VRH, suggesting that those with a history of lower pain tolerance could benefit the most from this intervention in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of virtual reality hypnosis for prostate cancer patients during transperineal biopsy/gold seed implantation: A needs assessment study. Wong, J., McGuffin, M., Smith, M., et al.[2023]

A meta-analysis of three randomized controlled trials involving 278 cancer patients found that aromatherapy massage with essential oils did not significantly reduce pain compared to usual care, with a standardized mean difference of 0.01.

The study suggests that aromatherapy massage may not be an effective pain management strategy for cancer patients, highlighting the need for further research with more objective measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials. Chen, TH., Tung, TH., Chen, PS., et al.[2020]

Prostate cancer is a significant health concern, with around 200,000 men expected to be diagnosed in 2001, highlighting the urgent need for effective screening and treatment methods.

Recent advancements are being made in various areas, including dietary approaches, novel systemic therapies, and alternative medicine, to improve outcomes for patients with prostate cancer, especially those with resistant forms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-art prostate cancer treatment and research. A report from the Cancer Institute of New Jersey. DiPaola, RS., Kumar, P., Hait, WN., et al.[2013]

A survey of 168 men with prostate cancer revealed that 50% were aware of alternative therapies, with tomatoes and low-fat diets being the most recognized options.

Only 16.5% of respondents were actively using alternative therapies, and many did not inform their healthcare providers, highlighting the need for doctors to discuss these therapies with patients to ensure safe and informed treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and use of alternative therapies in UK prostate cancer patients-isn't it time we were in the know? Cheetham, PJ., Le Monnier, KJ., Brewster, SF.[2019]

Aromatherapy is commonly used by cancer patients and has been shown to reduce psychological distress and improve symptom control, as supported by quantitative studies.

Through focus group interviews, patients highlighted the importance of the therapy's context and their preconceived notions about its value, suggesting that the environment and personal beliefs significantly influence their experiences with aromatherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer patients' experiences and evaluations of aromatherapy massage in palliative care. Dunwoody, L., Smyth, A., Davidson, R.[2004]

In a pilot study involving 46 cancer patients, adjunctive aromatherapy massage did not show statistically significant improvements in mood, quality of life, or physical symptoms compared to conventional care alone, although both groups reported improvements.

Despite the lack of measurable benefits, patients expressed high satisfaction with the aromatherapy treatment and a desire to continue, indicating potential value in patient experience even if clinical outcomes were not significantly different.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does aromatherapy massage benefit patients with cancer attending a specialist palliative care day centre? Wilcock, A., Manderson, C., Weller, R., et al.[2017]

References

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Addition of Androgen-Deprivation Therapy or Brachytherapy Boost to External Beam Radiotherapy for Localized Prostate Cancer: A Network Meta-Analysis of Randomized Trials. [2022]

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Androgen deprivation therapy use and duration with definitive radiotherapy for localised prostate cancer: an individual patient data meta-analysis. [2022]

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Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer. [2022]

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Pathological stage, surgical margin and lymphovascular invasion as prognostic factors after salvage radiotherapy for post-prostatectomy relapsed prostate cancer - outcomes and optimization strategies. [2022]

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Sequence of hormonal therapy and radiotherapy field size in unfavourable, localised prostate cancer (NRG/RTOG 9413): long-term results of a randomised, phase 3 trial. [2021]

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Virtual reality exposure therapy in anxiety disorders: a systematic review of process-and-outcome studies. [2018]

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Virtual reality exposure versus cognitive restructuring for treatment of public speaking anxiety: a pilot study. [2018]

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Virtual reality exposure therapy for the treatment of anxiety disorders: an evaluation of research quality. [2022]

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Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. [2021]

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The use of virtual reality hypnosis for prostate cancer patients during transperineal biopsy/gold seed implantation: A needs assessment study. [2023]

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The Clinical Effects of Aromatherapy Massage on Reducing Pain for the Cancer Patients: Meta-Analysis of Randomized Controlled Trials. [2020]

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State-of-the-art prostate cancer treatment and research. A report from the Cancer Institute of New Jersey. [2013]

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Attitudes and use of alternative therapies in UK prostate cancer patients-isn't it time we were in the know? [2019]

14. England pubmed.ncbi.nlm.nih.gov

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Does aromatherapy massage benefit patients with cancer attending a specialist palliative care day centre? [2017]