Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally Implanted Venous Access Device (IVAD) for Chemotherapy Under Local Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 5
- 主要终点
- mean of pain felt during the whole IVAD procedure
研究概览
简要总结
Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
详细描述
Evaluate the efficacy of virtual reality and music therapy on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 18 and 85 years.
- •Patient with cancer care and having a totally Implanted Venous Access Device (IVAD) procedure under local anesthesia for chemotherapy.
- •Absence of anxiolytic premedication.
- •Patient affiliated to social insurance.
- •Absence of contra-indication to the use of virtual reality, music therapy instrument or local lidocaine anesthesia.
- •Signed informed consent form.
排除标准
- •Patient already participated to this study.
- •Patient deprived of liberty or under legal representative or under curatorship.
- •Psychiatric disease enabling communication.
- •Deafness or visual impairement.
- •Patient under beta-blockers medication.
- •Chronic pain present and not equilibrated before the measured procedure as > 3 by the NRS.
- •Tracheotomy.
- •Low cervical tumor, or bilateral low cervical adenopathies.
- •Compression or jugular stenosis (uni or bilateral).
- •Jugular or subclavian thrombosis.
- •Patient under anticoagulants medication or having hesmostasis troubles.
- •Claustrophobia or thalassophobia inducing the possibility of rejecting the virtual reality mask or music therapy mask.
- •Patients not speaking french.
- •Pregnant and breastfeeding women.
结局指标
主要结局
mean of pain felt during the whole IVAD procedure
时间窗: 1 day
pain means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no pain and 10 the maximum pain feeling.
mean of anxiety felt during the whole IVAD procedure
时间窗: 1 day
Anxiety means will be measured with the Numerical Rating Scale (NRS) from 0 to 10 with 0 corresponding to no anxiety and 10 the maximum anxiety feeling.
次要结局
- Global patient satisfaction of NRS and comparison between the 3 groups.(1 day)
- Pain NRS means felt during the procedure and comparison.(1 day)
- Correlation coefficient between the ANI air under the curve and the pain measure with the numerical rating scale.(1 day)
- Tolerance evaluated by NRS and responses to the closed questions (dizziness, nausea, suffocating feeling) completed at the end of the procedure.(1 day)
- Anxiety NRS means felt during the procedure and comparison.(1 day)