Virtual Reality for Cervical Cancer Comfort During Brachytherapy

Overseen By Matthew R Kovak

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arkansas

Disqualifiers: Seizure disorder, Motion sickness, Migraine, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing whether using virtual reality (VR) to distract patients can make brachytherapy for cervical cancer more comfortable. The study will compare patient experiences with and without VR during treatment. The goal is to see if VR can reduce pain and anxiety, making the procedure more tolerable. Virtual reality (VR) has been explored as a non-pharmacological method to manage pain and anxiety in cancer patients, showing potential benefits in various medical contexts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Oculus Quest 2 Virtual Reality Headset for cervical cancer comfort during brachytherapy?

Research shows that virtual reality (VR) can help reduce anxiety, depression, and pain in cancer patients, suggesting it might also help improve comfort during cervical cancer treatments like brachytherapy. ^{1 2 3 4 5}

Is using the Oculus Quest 2 VR headset generally safe for humans?

Research on virtual reality (VR) headsets, including the Oculus Quest 2, shows they are generally safe for use in humans, with only mild side effects like headache, dizziness, nausea, and neck pain reported in some studies. ^{4 6 7 8 9}

How does the virtual reality treatment for cervical cancer during brachytherapy differ from other treatments?

The virtual reality treatment is unique because it uses immersive technology to distract patients during brachytherapy, potentially reducing anxiety and pain without the need for sedatives like nitrous oxide. This approach is different from traditional methods that rely on medication for comfort. ^{3 10 11 12 13}

Research Team

Gary Lewis, MD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for women aged 18 or older with a confirmed diagnosis of gynecologic cancer (like cervical cancer) that requires brachytherapy. Participants must be able to give written consent. It's not suitable for those with certain phobias, severe vision or hearing issues, history of seizures or motion sickness due to visual triggers, or any condition that would interfere with wearing a VR headset.

Inclusion Criteria

I have a gynecologic cancer that needs specific radiation therapy.

I am a woman and 18 years old or older.

Able to provide written consent

Exclusion Criteria

I have a history of high eye pressure.

I have a history of seizures, severe motion sickness, dizziness, or migraines triggered by visual disturbances.

I do not have claustrophobia, thalassophobia, cleithrophobia, or similar fears.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo four rounds of brachytherapy with and without VR distraction

3 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• The Oculus Quest 2 Virtual Reality Headset (Behavioural Intervention)

Trial Overview The study tests if using the Oculus Quest 2 Virtual Reality Headset during brachytherapy can improve patient satisfaction and reduce pain and the need for painkillers or anxiety medication. The goal is also to see how well VR technology fits into the clinical routine.

Participant Groups

Group I: Sequence Group D Experimental Treatment 1 Intervention

VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.

Group II: Sequence Group C Experimental Treatment 1 Intervention

VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.

Group III: Sequence Group B Experimental Treatment 1 Intervention

VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.

Group IV: Sequence Group A Experimental Treatment 1 Intervention

VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Findings from Research

In a study involving 90 oncology patients aged 7-19, Immersive Virtual Reality (VR) showed a greater positive impact on mood states compared to an iPad control, with patients reporting improved mood and reduced negative symptoms.

While both interventions were beneficial, the effectiveness of VR was influenced by factors such as the child's illness severity, age, sex, and level of immersion, suggesting that these elements should be considered in future applications of VR in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the use of Immersive Virtual Reality to enhance Psychological Well-Being in Pediatric Oncology: A pilot randomized controlled trial. Tennant, M., Youssef, GJ., McGillivray, J., et al.[2021]

A study involving 14 residents showed that virtual reality (VR) training for intracavitary brachytherapy significantly improved their self-confidence and technical skills, with confidence scores rising from 1.43 to 3.36 after the simulation.

Residents also completed the procedure faster, with average implant times decreasing from 5:51 to 3:34 minutes, indicating that VR training not only enhances confidence but also improves efficiency in performing brachytherapy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality-based simulation improves gynecologic brachytherapy proficiency, engagement, and trainee self-confidence. Taunk, NK., Shah, NK., Hubley, E., et al.[2021]

In a pilot study involving 30 adolescents with cancer undergoing lumbar punctures, the use of virtual reality (VR) glasses showed a trend towards lower pain scores compared to a control group, although the difference was not statistically significant.

77% of the adolescents using VR reported that it helped distract them from the procedure, suggesting that VR could be a useful nonpharmacologic tool for pain management during painful medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Sander Wint, S., Eshelman, D., Steele, J., et al.[2022]

A study involving 123 adults undergoing chemotherapy found that using virtual reality (VR) as a distraction made the treatment feel shorter and was generally well-received, with 82% of participants expressing a desire to use it again.

Despite the positive feedback on the VR experience, the intervention did not significantly reduce symptom distress immediately or two days after chemotherapy, indicating that while VR can enhance the treatment experience, it may not alleviate chemotherapy-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality: a distraction intervention for chemotherapy. Schneider, SM., Hood, LE.[2018]

A virtual reality application designed for patients undergoing radiotherapy significantly improved understanding of the treatment, with 74% of participants reporting a better grasp of their radiotherapy plan after the VR experience.

The VR session also helped reduce anxiety in 57% of patients who initially felt anxious about their treatment, suggesting that this technology could be an effective educational tool for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Education for Patients Undergoing Radiation Therapy. Wang, LJ., Casto, B., Luh, JY., 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]

A virtual reality relaxation intervention was found to be feasible and acceptable for patients with primary brain tumors, with 50% enrollment from those approached and high satisfaction reported by 90% of participants.

The intervention had a low incidence of mild adverse effects (7 cases), indicating it is a safe option for managing distress and anxiety during neuroimaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. King, AL., Roche, KN., Leeper, HE., et al.[2023]

Radiation therapy, particularly image-guided adaptive brachytherapy, is crucial for treating locally advanced cervical and vaginal cancers, as it allows for higher doses to the tumor while protecting surrounding healthy tissues.

The use of 3D-printed applicators in brachytherapy is becoming more common, addressing limitations of standard applicators by providing customized solutions that improve target volume coverage in patients with complex anatomical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of 3D Printing Technology in Gynaecological Brachytherapy-A Narrative Review. Segedin, B., Kobav, M., Zobec Logar, HB.[2023]

In a study of 35 patients undergoing cervical brachytherapy, using virtual reality (VR) for distraction during applicator removal resulted in comparable levels of anxiety and pain to those experienced with nitrous oxide (N2O) sedation, suggesting VR could be a viable alternative.

While the VR group reported slightly higher anxiety levels during the procedure, they experienced lower peak pain scores compared to the N2O group, indicating that VR can effectively manage discomfort, although some patients did report mild side effects like nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality distraction during uterovaginal brachytherapy applicators' removal: A pilot comparative study. Varnier, R., Brière, O., Brouillard, T., et al.[2021]

A new method for image-guided catheter placement in high dose rate (HDR) brachytherapy for gynecologic cancers has been developed, showing a targeting error of less than 2.9mm, which is comparable to existing clinical navigation systems.

This technology aims to improve the accuracy of catheter placement, potentially maximizing tumor coverage while minimizing damage to surrounding organs like the bladder and rectum, enhancing the safety and efficacy of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EM-Navigated Catheter Placement for Gynecologic Brachytherapy: An Accuracy Study. Mehrtash, A., Damato, A., Pernelle, G., et al.[2021]

A high-fidelity, ultrasound- and CT-compatible gynecologic brachytherapy training simulator was successfully developed to enhance the training of residents, addressing the need for better procedural fidelity in training models.

The simulator's realistic features, such as a cervical os and palpable tumor, aim to improve the proficiency of brachytherapists, potentially leading to better treatment outcomes and survival rates for women with advanced gynecologic cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new development in ultrasound-compatible gynecologic brachytherapy simulators. Fields, EC., Joyner, MM., Singer, L., et al.[2021]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Exploring the use of Immersive Virtual Reality to enhance Psychological Well-Being in Pediatric Oncology: A pilot randomized controlled trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual reality-based simulation improves gynecologic brachytherapy proficiency, engagement, and trainee self-confidence. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Virtual reality: a distraction intervention for chemotherapy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Virtual Reality-Based Education for Patients Undergoing Radiation Therapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Scotland pubmed.ncbi.nlm.nih.gov

Effects of immersive virtual reality for managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory randomised controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of 3D Printing Technology in Gynaecological Brachytherapy-A Narrative Review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Virtual reality distraction during uterovaginal brachytherapy applicators' removal: A pilot comparative study. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

EM-Navigated Catheter Placement for Gynecologic Brachytherapy: An Accuracy Study. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

A new development in ultrasound-compatible gynecologic brachytherapy simulators. [2021]