University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Location status: Recruiting
Location contact
Joseph A Holley
CONTACT
Matthew R Kovak
CONTACT
NCT Number: NCT05440760
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Little Rock, Arkansas, 72205, United States
Location status: Recruiting
Joseph A Holley
CONTACT
Matthew R Kovak
CONTACT
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The hardware includes the wireless headset with integrated headphones which will block the sight and sounds of the clinical setting as well as the hand controllers for the interactive VR experience, which will be delivered through any of three VR software options (subject may choose one or more from the following options):
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 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.
Time frame: 3 weeks
Compare the subject's procedural anxiety scores (using a VAS pre- and post-procedure) between sessions with VR and sessions without VR.
Time frame: 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.
Time frame: 3 weeks
Compare the dose(s) of benzodiazepine anxiolytics per session (using a benzodiazepine conversion calculator) between sessions with VR and sessions without VR
Contact information is provided by the study sponsor or research team.
Joseph A Holley
CONTACT
Vernon Sincere
CONTACT
University of Arkansas
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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