Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The number of times a technical problem occurs with the VR distraction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, ≥ 18 years of age
- •Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy
- •Able to provide written consent
排除标准
- •Severe vision or hearing problems that may hinder the ability to see or hear clearly through the VR headset or other condition that may interfere with the placement of the VR headset such as a head, ear or facial wound
- •History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras
- •Known history of elevated intraocular pressure
- •Claustrophobia, thalassophobia, cleithrophobia or similar phobias
- •Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
研究组 & 干预措施
Sequence Group A
VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.
干预措施: The Oculus Quest 2 Virtual Reality Headset (Device)
Sequence Group B
VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.
干预措施: The Oculus Quest 2 Virtual Reality Headset (Device)
Sequence Group C
VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.
干预措施: The Oculus Quest 2 Virtual Reality Headset (Device)
Sequence Group D
VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.
干预措施: The Oculus Quest 2 Virtual Reality Headset (Device)
结局指标
主要结局
The number of times a technical problem occurs with the VR distraction
时间窗: 3 weeks
The number of eligible subjects who enroll onto the study.
时间窗: 3 weeks
The number of subjects who withdraw or are withdrawn from the study.
时间窗: 3 weeks
The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety.
时间窗: 3 weeks
次要结局
- Determination of VR distraction during brachytherapy treatment for cervical cancer pain(3 weeks)
- Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety.(3 weeks)
- Opiod dose(3 weeks)
- Benzodiazepine dose(3 weeks)