An Educational Video to Address Parental Concern in Lumbar Puncture Consent: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort
研究概览
简要总结
The purpose of this study is to improve the lumbar puncture (LP) consent process for pediatric patients. Though a commonly performed and safe procedure, LP can be anxiety-provoking for parents. By using an educational video on a handheld device at the time of consent, we hope to improve parent understanding and comfort with the procedure.
详细描述
Introduction
Lumbar puncture is a safe procedure commonly performed on pediatric patients for a variety of indications. Parents are informed of and consented to this procedure, but are often left with concerns and doubts. There are no published studies of the nature of the concerns of parents in North America, and no studies examining a process to improve pediatric lumbar puncture consent. Here the investigators conduct a randomized control study of a short educational video on a handheld device as an adjunct to the formal consent process.
Methods: 72 patients were enrolled, evenly divided between the control arm and video arm of the study. A survey was provided examining four key indices: parent self-rated understanding of the procedure, their perception of its safety, their perception of the painfulness and their overall comfort with their child undergoing LP. In addition, demographic characteristics such as prior experience with LP or epidural, language spoken at home, age of the child and indication for lumbar puncture, as well as qualitative information about parent concerns were collected.
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
- Double (Participant, Care Provider)
盲法说明
The caregiver obtaining consent for lumbar puncture does not know if the parent will be randomized to see the video; the parent is not aware they may be randomized to see a video when they respond to the first survey about their concerns.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •parent of a patient less than 17 years of age
- •parent present for consent
- •patient under the care of the neurology team (directly or consulting)
- •consenting physician able to communicate with parent directly or through a translator
排除标准
- •patients with emergent indications for lumbar puncture, such as bacterial meningitis
- •parent's unable to communicate in English and no translator was available
- •consent not performed in person (over the phone)
结局指标
主要结局
Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort
时间窗: within 10 minutes of consent discussion (controls) or viewing the video (video group)
4 separate Likert scales from 1-10 (1 is low, 10 is high) for each of understanding of procedure, pain perception, safety perception and comfort with procedure, each individual scale will be reported. For understanding, safety and comfort, a higher score represents better outcome, for pain perception a lower score represents better outcome.
次要结局
未报告次要终点
研究者
Ash Singhal
Principle Investigator
University of British Columbia