The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Official Title: Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Study ID: NCT05440760
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Name: Gary Lewis, MD
Affiliation: University of Arkansas
Role: PRINCIPAL_INVESTIGATOR