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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group A | Experimental | VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4. |
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| Sequence Group B | Experimental | VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3. |
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| Sequence Group C | Experimental | VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2. |
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| Sequence Group D | Experimental | VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Oculus Quest 2 Virtual Reality Headset | Device | 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):
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| Measure | Description | Time Frame |
|---|---|---|
| The number of eligible subjects who enroll onto the study. | 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 times a technical problem occurs with the VR distraction | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of VR distraction during brachytherapy treatment for cervical cancer pain | 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. | 3 weeks |
| Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph A Holley | Contact | 501-686-8274 | jaholley@uams.edu | |
| Vernon Sincere | Contact | 501-686-8274 | vjsincere@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Santanu Samanta, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Recruiting | Little Rock | Arkansas | 72205 | United States |
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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.
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Compare the subject's procedural anxiety scores (using a VAS pre- and post-procedure) between sessions with VR and sessions without VR. |
| 3 weeks |
| Opiod dose | Compare the dose(s) of opioid pain medication per session (using morphine milligram equivalents [MMEs]) between sessions with VR and sessions without VR. | 3 weeks |
| Benzodiazepine dose | Compare the dose(s) of benzodiazepine anxiolytics per session (using a benzodiazepine conversion calculator) between sessions with VR and sessions without VR | 3 weeks |