Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Evaluating the anxiety of the patient benefiting from a virtual reality session versus normal care management
研究概览
简要总结
In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years.
A meta-analysis on radiotherapy indicated that 10 to 20% of patients had clinically significant levels of anxiety at the beginning of radiotherapy.
Indeed, several factors generate this tension, above all the new or unfamiliar environment, the imposing and noisy scanner, the restraints that are difficult to bear or the nudity required for the examination.
This anxiety has an impact on performance of the planning CT scan examination, an essential step for the future treatment.
The radiotherapy unit of the Centre Hospitalier Departemental de Vendee has put in place resources to reduce anxiety felt during treatment sessions (music therapy, conversational hypnosis, sophrology or aromatherapy). However, nothing has been put in place to reduce the anxiety of patients in the period preceding the planning CT scan.
Virtual reality software seems to be a good alternative that requires fewer human resources.
The research hypothesis is that patients who have benefited from the virtual reality software will have a lower level of anxiety before the planning CT scan than patients who have not benefited from virtual reality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix)
- •Patient ≥ 18 years old,
- •Patient who has the capacity to understand the protocol and has given written consent to participate in the research,
- •Patient with social security coverage.
排除标准
- •Metastatic patients
- •Patients with previous radiotherapy
- •Patients with a diagnosis of hearing impairment
- •Patients with major cognitive disorders (such as dementia)
- •Psychiatric pathology such as schizophrenia
- •Patients with epilepsy or hypersensitivity to flashing lights
- •Patient with a pacemaker, hearing aid or defibrillator
- •Claustrophobic patients
- •Patients sensitive to motion sickness
- •Patients who are visually impaired or blind
- •Patients with migraine
- •Patients with skin defects and open wounds in the area where the helmet is applied (face or scalp) or in the eyes
- •Patients under guardianship, curators or deprived of liberty
- •Non French speaking patient
- •Illiterate patient
- •Patient participating in another clinical investigation or interventional clinical research protocol involving a drug
- •Pregnant or breastfeeding patient
研究组 & 干预措施
Virtual reality
Virtual reality session performed before the planning CT scan
干预措施: Virtual reality software (Device)
Normal care
Normal care without intervention
结局指标
主要结局
Evaluating the anxiety of the patient benefiting from a virtual reality session versus normal care management
时间窗: 10 minute before the planning CT scan
Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.
次要结局
未报告次要终点