Impact of Virtual Reality on the Quality of Life of Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- QLQ-C30
研究概览
简要总结
Anxiety, nausea and vomiting are common side effects in paediatric patients receiving chemotherapy. chemotherapy. New evidence supports the efficacy of immersive virtual reality in improving symptoms of anxiety and distress, including nausea and vomiting, in this vulnerable group. This research will evaluate the efficacy of virtual reality in managing anxiety, nausea and vomiting in cancer patients receiving their first line of chemotherapy and will also measure the quality of life of these patients and evaluate patient and nursing staff satisfaction
详细描述
For cancer patients, virtual reality proved more effective than other forms of distraction in relieving anxiety, depression and fatigue during chemotherapy. Although pain and anxiety in cancer patients are managed proactively, this study was designed to measure the quality of life of these patients, assess patient and carer satisfaction, evaluate the effectiveness of virtual reality in reducing anxiety during the first three sessions of chemotherapy, and assess the impact of virtual reality on preventive and acute chemotherapy-induced fatigue, nausea and vomiting.
This is a clinical study with a therapeutic aim using a non-medicinal, interventional, prospective, multi-centre, controlled and randomised technique, with two parallel groups. It is clinical research involving the human person category 2, involving only minimal risks and constraints. The two arms are Arm A: study questionnaires with virtual reality (VR) Arm B: study questionnaires without virtual reality, standard care (SC)
A visit will be made during the 3 cycles of chemotherapy during which arm A will be immersed in Virtual Reality with the Healthy Mind VR programme.
programme, and patients in arm B will receive standard care without hypnotic support.
There will also be a pre-inclusion visit 7 days before the first cycle. and visits at 3, 6 and 9 months after the 3 cycles of chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy-naive patient
- •Patient with first-line indication for intravenous cyclic chemotherapy
- •Affiliated to a social security system
- •Having received full information on the organization of the research and having given free, informed and written consent signed by the participant and the investigator
- •Patient understands French or English
- •Expected duration of chemotherapy session for the first 3 cycles greater than 30 minutes
排除标准
- •Patient with communication disorders preventing informed consent
- •Patient under legal protection (guardianship, curatorship, safeguard of justice)
- •Patients suffering from epilepsy
- •Severe visual or hearing impairment preventing use of headphones
- •Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
- •Patients with infections or facial wounds
- •Patients with severe claustrophobia
- •Patients with pacemakers
- •Patients with known cognitive or learning problems,
- •Patients with brain tumors or metastases,
- •Patients suffering from motion sickness
- •Expected duration of chemotherapy session for the first 3 cycles of 30 minutes or less.
结局指标
主要结局
QLQ-C30
时间窗: at the start of cycle 1 (each cycle is 28 days); 3,6,9 months post chemo, at the beginning of the 3rd month post chemo, at the beginning of the 6th month post chemo and at the beginning of the 9th month post chemo
Measurement of the quality of life observed in patients. The QLQ-C30 questionnaire consists of 30 questions on the patient's state of physical and mental health. There are 28 questions with scores ranging from 1 = not at all to 4= very much and two questions with scores ranging from 1= very poor to 7= excellent.
Measuring patient and nurse satisfaction with the chemotherapy procedure
时间窗: after the first chemotherapy session on day 1 of cycle 1 and 3 (each cycle lasts 28 days)
Use of a patient questionnaire with a 10-point scale assessed on a five-point scale ranging from 1=strongly disagree disagree to 5 = strongly agree
MAT
时间窗: after the first chemotherapy session on day 1 of cycle 2 and 3 (each cycle lasts 28 days)
Assessment of acute nausea and vomiting in patients induced by chemotherapy. 4 questions are used to assess nausea and vomiting 24 hours after chemotherapy and these 4 questions are again used to assess late nausea and vomiting. There are 2 questions with a yes or no choice, 1 question with a numerical answer and 1 question with a 10-point numerical scale with 0= none and 10= maximum difficulty.
次要结局
- HAD Score(Before the start of the first chemotherapy session on day 1 of cycle 1 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1 and 2 (each cycle is 28 days).)
- Heart rate(Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).)
- VAS Score(Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).)
- Blood pressure(Before the start of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days) and after the end of the first chemotherapy session on day 1 of cycle 1, 2 and 3 (each cycle is 28 days).)