Observational Prospective Study Measuring the Impact of the Use of a Hypnotic Script Associated With Virtual Reality on the Pain of the Child's Sickle Cell During a Vaso-occlusive Crisis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- pain assessment with score (patient)
研究概览
简要总结
The purpose of this study is to evaluate the effect of Virtual Reality induced Hypnosis on patients' pain scores, anxiety and the use of analgesics during a vaso-occlusive crisis
详细描述
Virtual reality hypnosis could probably reduce vaso-occlusive crisis-related (vaso-occlusive crisis) anxiety and pain and provide the patient with means of optimizing the ability to cope with the painful and anxiety-provoking situations encountered in general pediatric unit.
However, this non-pharmacological analgesic technique is little used in the context of vaso-occlusive crisis in children and adolescents in French pediatric services.
Currently, the average pain scores of children and adolescents hospitalized for vaso-occlusive crisis after treatment in the emergency department is 6 out of 10 on a simple numerical scale (according to a preliminary study conducted on 30 files of sickle cell disease patients over 6 years of age hospitalized in general pediatrics, Trousseau AP-HP hospital over a period of 6 months in 2018), despite the implementation of optimal pharmacological means with regard to the HAS analgesia recommendations. The pain score stays high despite a well-conducted analgesic treatment.
Our hypothesis is that virtual reality hypnosis could potentiate the effects of virtual reality by hypnotic suggestions specific to the pain of patients with vaso-occlusive crisis . This is a pain and anxiety reduction strategy that has, to our knowledge, never been evaluated.
So this is innovative by the method but also of the pediatric target population suffering from recurrent and severe pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child over 6 years of age on the day of acceptance of the study (no upper limit)
- •Suffering from sickle cell disease whatever genotype
- •Admission in hospital for a VOC (vaso-occlusive crisis)
- •Informed and signed consent by at least one legal guardian, if child is minor, and verbal agreement of the child himself.
排除标准
- •Deaf patient, visually impaired patient, claustrophobic and/or aquaphobic patient
- •Patient not understanding French
- •History of psychiatric illness such as paranoia, schizophrenia, manic-depressive psychosis, high suicide risk patient.
- •The patient may be included several times in the study if he is hospitalized again during the inclusion period.
结局指标
主要结局
pain assessment with score (patient)
时间窗: hours 3 after a virtual reality
Measuring pain thanks to score pain by the patient 3 hours after a Virtual Reality session performed within the first 6 hours after arrival in the general pediatrics unit Patients will use le Faces Pain Scale - Revised.
次要结局
- pain assessment with score (health care personnel)(3 hour after a virtual reality)
- patient satisfaction assessment(3 hour)
- pain assessment with score (patient)(1 hour after a virtual reality)
- anxiety assessment(3 hour after HVR)
- health care personnel satisfaction assessment(5 months)