Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 1:55 PM
Study NCT ID:
NCT05440760
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2022-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: