Using of Virtual Reality to Relieve Procedural Pain in Pediatric Oncology.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain level measured by VAS (self-evaluation) during the first care using standard treatment.
研究概览
简要总结
Medical procedures can be a very frightening experience for children. It is known that children who received painful medical procedures can develop a higher sensitivity of pain during their following experiences.
During their treatments for malignant diseases, children are exposed to a lot of painful procedures (eg. needle insertion, lumbar punction, myelogram, etc...)
Therefore, medical societies propose the use of interventions like distraction techniques for pain management in complement of pharmacological treatment.
In addition, the repetitions of painful procedures and ineffective prevention of pain can create care phobia.
Within this context, immersive and participative virtual reality (VR) could be an innovative distraction technique for pain management among children undergoing medical procedures.
Attention Pain Theory can explain how virtual reality can reduce the perception of pain. Attention is required to feel pain. When the patient is focused on another subject like an immersive virtual environment, his brain is less available to treat information like painful stimulus from care procedures.
The investigators hypothesis is that VR can reduce procedural-related pain and can decrease fear during the following procedures.
Results of previous studies are varied : some showed a non-significant reduction of patient's procedural pain despite the use of VR, whereas others concluded to a decrease of pain. The question of the benefit of VR for the patients who are exposed to repeated painful procedures remains still unclear, especially with patients who are likely to feel chronic pain or many pain-related exposures.
The aim of this study is to evaluate the non-inferiority of virtual reality as a distraction technique for pain management in children and adolescents with onco-hematological diseases, undergoing painful procedures, compared to standard of care.
详细描述
VIRTUOSO is a study that aims to evaluate the impact of using a virtual reality headset to prevent care-induced pain in pediatric oncology. This study plans to include 34 patients. It is a single-center, non-inferiority, controlled, with cross-over study.
Efficiency of VR will be evaluated for each patient across 3 potentially painful care-procedures :
For the first treatment, the child will benefit usual distraction and pain prevention techniques.
For the 2nd treatment, the child will use a VR headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age.
For the 3rd treatment, the child will choose his/her favorite technique.
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
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Quantitative component:
- •Child aged 7 to 18 years
- •Child followed in pediatric onco-hematology in the context of hematological malignancy or non malignant hematology or solid tumor management.
- •Child who has already experienced a potentially painful care procedure before entry the study
- •Child who will have the same potentially painful care procedure (Hüber needle placement or lumbar puncture) on three occasions during the course of their care.
- •Child with consent.
- •Child whose parental authority holders have given their consent to participate to the study.
- •Qualitative component:
- •Professional who used both care-induced pain prevention techniques and agreed to be interviewed.
- •A parent or guardian.
排除标准
- •Child who refuse to use this distraction technique (VR).
- •Child who refuse to not use MEOPA during VR.
- •Child who hasn't experienced the potentially painful care procedure that will be done during the study at least once before inclusion
- •Child who does not speak French and whose parents do not speak French
结局指标
主要结局
Pain level measured by VAS (self-evaluation) during the first care using standard treatment.
时间窗: Immediately after the first care.
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Pain level measured by VAS (self-evaluation) during the second care using virtual reality
时间窗: Immediately after the second care .
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
Pain level measured by VAS (self-evaluation) during the third care using virtual reality or standard treatment
时间窗: Immediately after the third care .
Pain levels measured on the VAS. VAS : Visual Analogue Scale . Minimum value : 0. Maximum value : 10. The maximum value is the worse outcome.
次要结局
- parent questionnaire.(Immediately after the 3rd intervention.)
- Thematic analysis of the verbatim collected during the semi-directive interviews with the parents after Care 3(Immediately after the 3rd intervention.)
- Percentage of children who choose VR in the 3rd care(Immediately after the 3rd intervention.)
- Patient questionnaire(Immediately after the 3rd intervention.)
- Ethnographic approach to caregivers' experiences after using the VR headset.(Through study completion - up to 20 months.)
- Side effects to the use of VR(During each intervention with virtual reality (care 2 and care 3 if VR is chosen). Up to 6 months.)