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临床试验/NCT06722638
NCT06722638招募中不适用

Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia

Children's National Research Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Primary Outcome: Feasibility

研究概览

简要总结

Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that patients receive is the delivery of chemotherapy directly into their spinal fluid via a spinal tap. This takes place approximately 20 times over the course of treatment. Most children and adolescents receive general anesthesia during this procedure to manage pain and anxiety. It is now understood that general anesthesia contributes to impairments in brain functioning in the long term. Therefore, it is important to identify ways to manage pain and anxiety during these procedures that does not include general anesthesia. The investigators propose to test whether virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), used with local anesthesia and the option for an anti-anxiety medication will be an adequate replacement for general anesthesia for participants 7 years of age and over, with ALL in the maintenance phase of treatment.

详细描述

Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will be long-term survivors. To help prevent disease recurrence in the central nervous system, patients receive intrathecal chemotherapy, delivered via lumbar puncture, at least 20 times over the course of treatment. Although critical for cure, this component of treatment is a risk factor for neurocognitive impairments that can subsequently affect the daily living skills and academic achievement of survivors. It is now understood that the general anesthesia used to manage pain and anxiety during lumbar punctures also contributes to impairments in neurocognitive functioning. Recent studies have demonstrated that the use of general anesthesia can be decreased by using local anesthesia and offering oral or IV anxiolytic medications. The investigators propose that adding virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), to local anesthesia and the option for anxiolytics will be superior to using those medications alone. The investigators' aim in this study is to demonstrate the feasibility of using VR, in conjunction with local anesthesia and oral/IV anti-anxiety medications, in participants 7 years of age and older with ALL in the maintenance phase of treatment. The multi-disciplinary investigator team, which includes experts in pediatric oncology, survivorship, patient reported outcomes, VR technology and VR content, is uniquely suited to successfully develop, implement, and evaluate this strategy. The investigators' long-term objective is to create a scalable and sustainable alternative to general anesthesia that will adequately manage pain and anxiety without compromising neurocognitive function. By systematically working towards this long-term objective, the investigators seek to help survivors of childhood cancer lead happy, normal lives, free from acquired neurocognitive impairment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Initial diagnosis of ALL or Lymphoma (as they receive the same therapy)
  • •In maintenance phase of treatment
  • •Still have 2 maintenance cycles planned
  • •Aged 7 and over
  • •Patient able to speak English
  • •Caregiver able to complete consent and study questionnaires in English or Spanish

排除标准

  • •Relapsed or refractory disease
  • •Previously required ultrasound guided LP procedure
  • •Already does LPs without anesthesia

研究组 & 干预措施

VR Arm

Experimental

Pain and anxiety management in this arm will include: topical numbing cream 30 minutes prior to the scheduled procedure, option for a 0.05mg/kg (max 2 mg) oral/IV dose of lorazepam. VR headsets will be donned. After sterile cleaning of the lumbar spine area, lidocaine will be injected between L3-4 or L4-5 for local anesthetic. A 22-gauge needle of appropriate length (1.5, 2.5, 3.5 inch) will be used to access the intrathecal space. Cerebral spinal fluid will be collected for evaluation (standard procedure) and IT chemotherapy will be administered.

干预措施: Use of Virtual Reality Headset (Other)

GA Arm

No Intervention

Pain and anxiety in this arm will be managed with general anesthesia, usually propofol, which is the current standard of care at Children's National Hospital.

结局指标

主要结局

Primary Outcome: Feasibility

时间窗: At time of Procedure

Number of participants able to receive intrathecal chemotherapy while using Virtual Reality to augment local anesthesia and the option of an anxiolytic for management of pain and anxiety during the lumbar puncture procedure.

次要结局

  • Secondary Outcome: Acceptability(1-3 months after first Lumbar Puncture)

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Levine

Medical Director, Survivorship and Supportive Care

Children's National Research Institute

研究点 (1)

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