Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
- Conditions
- Endocervical Cancer
- Registration Number
- NCT05440760
- Lead Sponsor
- University of Arkansas
- Brief Summary
The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow.
The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute pain, and need for analgesics or anxiolytics.
- Detailed Description
This will be a prospective pilot study conducted at UAMS. All subjects will experience VR distraction using a crossover design in which each subject receives four rounds of brachytherapy: two rounds with VR distraction and two rounds without VR distraction. Brachytherapy will be conducted per SoC workflow. Subjects will be placed into four treatment-sequence groups in a 1:1:1:1 allocation ratio via permuted block randomization with randomized block sizes of four or eight.
The four treatment-sequence groups will follow the four-session treatment schedules outlined below, in which "V" denotes the sessions when VR distraction is used while "N" denotes the sessions when it is not:
* Sequence Group A will be treated according to schedule VVNN.
* Sequence Group B will be treated according to schedule VNNV.
* Sequence Group C will be treated according to schedule NNVV.
* Sequence Group D will be treated according to schedule NVVN.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
- Female, ≥ 18 years of age
- Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy
- Able to provide written consent
- Severe vision or hearing problems that may hinder the ability to see or hear clearly through the VR headset or other condition that may interfere with the placement of the VR headset such as a head, ear or facial wound
- History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras
- Known history of elevated intraocular pressure
- Claustrophobia, thalassophobia, cleithrophobia or similar phobias
- Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The number of times a technical problem occurs with the VR distraction 3 weeks The number of subjects who withdraw or are withdrawn from the study. 3 weeks The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety. 3 weeks The number of eligible subjects who enroll onto the study. 3 weeks
- Secondary Outcome Measures
Name Time Method Determination of VR distraction during brachytherapy treatment for cervical cancer pain 3 weeks Compare the subject's procedural pain scores (using a visual analog scale \[VAS\] pre- and post-procedure) between sessions with VR and sessions without VR.
Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety. 3 weeks Compare the subject's procedural anxiety scores (using a VAS pre- and post-procedure) between sessions with VR and sessions without VR.
Opiod dose 3 weeks Compare the dose(s) of opioid pain medication per session (using morphine milligram equivalents \[MMEs\]) between sessions with VR and sessions without VR.
Benzodiazepine dose 3 weeks Compare the dose(s) of benzodiazepine anxiolytics per session (using a benzodiazepine conversion calculator) between sessions with VR and sessions without VR
Trial Locations
- Locations (1)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States