Anxiety in the Context of Chemotherapy Infusion: Is There an Association Between the Use of Virtual Reality Goggles and Changes in Anxiety-Related Symptoms?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Difference in anxiety levels
研究概览
简要总结
This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.
SECONDARY OBJECTIVES:
I. To evaluate whether there is a short-term effect of VR use in anxiety levels.
II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking: Ability to interact with virtual reality content may be impacted by inability to understand English; moreover, paper questionnaires will only be provided in English.
- •Older than 18 years of age, and younger than 89 years of age. All sexes/gender identities and members of all races and ethnic groups will be included.
- •Planned to receive chemotherapy infusion for head and neck, breast, thoracic, and hematologic cancers at the Oregon Health & Science University (OHSU) South Waterfront Center for Health & Healing building 2 (there are no restrictions related to prior chemotherapy infusions or other cancer treatments).
- •Chemotherapy treatment lasting at least 10 minutes.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Social or psychiatric conditions that may interfere with compliance.
- •Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset. This would limit the ability to utilize the VR headset.
- •History of seizure or epilepsy.
- •History of vertigo or persistent dizziness.
- •Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators.
- •Children.
- •Pregnant women.
- •Decisionally impaired adults.
- •Prisoners.
结局指标
主要结局
Difference in anxiety levels
时间窗: Before the start of chemotherapy infusion and 30-minutes of virtual reality (VR)/smartphone use is completed
Will be assessed in the treatment and control groups determined by the difference in the scores provided by the State Anxiety Inventory before and right after VR use. Range of scores is 20-80, the higher score indicating greater anxiety. Will be compared using two-sample t-test to compare the anxiety levels change before and after VR between intervention group and control group (VR vs control). The effect of VR on anxiety levels will be described using a linear regression model addressing the unanticipated imbalance between treatment groups after randomization adjusting for the confounder.
次要结局
- Short-term difference in anxiety levels(Before VR goggle use and immediately after chemotherapy infusion is complete)
- Participants' satisfaction with the VR device(Immediately after chemotherapy infusion is complete)
研究者
Ryan Li, MD
Principal Investigator
OHSU Knight Cancer Institute