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Spots Global Cancer Trial Database for Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Contact Details

Name: Gary Lewis, MD

Affiliation: University of Arkansas

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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