跳至主要内容
临床试验/NCT02595307
NCT02595307Unknown不适用

Role of a Written Summary on Risk Recall During Consent Process for Cleft Palate Repair

IWK Health Centre2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Number of risks recalled

研究概览

简要总结

To determine if providing a written document in addition to the standard oral discussion of surgical risks improves risk recall for the parents/guardians of a child seen in consultation for cleft palate surgery, and if this has any effect on overall satisfaction after the procedure

详细描述

The current standard of care as it relates to informed consent in the pediatric population involves providing the parents or guardians of the child undergoing surgery with an oral discussion prior to the surgical procedure. However, providing parents with an oral discussion alone may be insufficient in the informed consent process as it has been shown that oral information tends to be retained poorly and crucial pieces of information tend to be forgotten. Conversely, it has been shown that properly informed patients are more satisfied, have a higher commitment to their treatment, and demonstrate less tendency toward filing legal claims. Furthermore, written material may help reduce anxiety in patients facing stressful events, such as surgery, and have been linked with overall improvement in satisfaction with their treatment

The investigators hypothesize that providing a written document in conjunction with the standard oral discussion improves the participants' risk recall in the informed consent process for their child's cleft palate repair surgery and increases their subjective satisfaction with the operation.

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
Single (Investigator)

入排标准

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

入选标准

  • Parents/guardians of a child referred to the IWK Cleft Palate Clinic for primary cleft palate repair surgery

排除标准

  • Inability to fluently communicate in English
  • Inability to read at a grade 8 level
  • Inability to provide informed consent

结局指标

主要结局

Number of risks recalled

时间窗: 3 weeks

The number of risks that are recalled by the patient at a 3 week follow up phone call.

次要结局

  • Participant Satisfaction as measured with the visual-analogue scale(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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