Exploring the Effects of an Informative Animated Video on Preoperative Anxiety in Children Undergoing Elective Otoplasty and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- modified Yale Preoperative Anxiety Scale (mYPAS)
研究概览
简要总结
The study is a prospective, randomized, single-blind controlled superiority trial to evaluate the effect of viewing an informative animated video a day prior to surgery on preoperative anxiety in pediatric patients scheduled for elective otoplasty. The primary outcome will be modified Yale Preoperative Anxiety Scale (mYPAS) score at the time of general anesthesia induction compared between families that were assigned to view the animated video the day before and those that were not. The participants for this study will be children undergoing elective otoplasty at the IWK Health Centre. Those participants randomized to the intervention group will receive a link to a short survey gauging parent anxiety levels. The survey will be followed by a link to an informative animated video which the participants and their families will watch. The control group will be participants assigned not to receive the email link to the informative animated video.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are undergoing an otoplasty alone with no other procedures on the same day
- •The patient must not have previously undergone an otoplasty; the patient must be between the ages of 4 and 12;
- •The patient must understand spoken English;
- •The participating parent must be able to read English at a grade six level; and the patient should not have received premedication.
排除标准
- •Under the age of 4 or over the age of 12
- •Have not undergone a previous otoplasty
研究组 & 干预措施
Control group (no video)
Children in this group will not receive a link to view an informational animated prior to their surgery date
Intervention group ( video)
Children in this group will receive a link to view an informational animated video 3 nights prior to their surgery date.
干预措施: animated video (Other)
结局指标
主要结局
modified Yale Preoperative Anxiety Scale (mYPAS)
时间窗: Data acquisition will occur within 24 hours. Recording will start once patient enters room and is positioned on OR table. Recording will stop one minute after induction mask is put on patient. Total recording time will be five minutes.
The mYPAS is a validated observational measure to assess the behaviour of children of all ages preoperatively and consists of 27 items divided into five domains (activity, emotional status, arousal state, vocalization, and use of parents).24,27,28 The mYPAS scores range from 22 to 100, with higher values indicating greater anxiety. The mYPAS is considered the gold-standard for observational preoperative anxiety assessment in paediatric patients.24,27-30
次要结局
- parental self-reported anxiety using the State-Trait Anxiety Inventory(Within 48 hours prior to arrival at the IWK for surgery and again upon arrival at the IWK immediately prior to their child leaving the waiting area to enter the operating room)
- modified Yale Preoperative Anxiety Scale (mYPAS)(mYPAS score while in the preoperative waiting area)
研究者
Michael Bezuhly
Head, Division of Plastic & Reconstructive Surgery Director, Craniofacial Program IWK Health Centre
IWK Health Centre