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临床试验/NCT02766452
NCT02766452已完成不适用

The Effects of a Preoperative Educational DVD on Parents' Participation in Their Child's Care in the Recovery Room at the Time of a Same-day Surgery: A Randomized Controlled Trial

University of Ottawa0 个研究点目标入组 105 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
主要终点
Parents' participation behaviors

研究概览

简要总结

The objectives of this study were to evaluate the effect of a preoperative educational DVD on parents' knowledge acquisition, participation and anxiety related to their child's care in the recovery room (RR). It also aimed at evaluating the DVD in terms of children's postoperative distress, pain, analgesic requirements and length of recovery.

详细描述

Following the development of a validated preoperative educational Digital Versatile Disc (DVD) for parents, a randomized clinical trial, with a pre-test-post-test control group, was conducted on 123 French or English speaking parent-child dyads whose child was aged from 3 to 10 years and underwent an ear-nose-throat (ENT) or dental same day surgery at a Canadian pediatric hospital. The parents in the control group received the standard preoperative preparation (verbal and written information about hospital procedures and the hospital's surgical virtual tour). The parents in the experimental group viewed the DVD and received the standard preoperative preparation. Parents and children were videotaped in the recovery room; parental participation and children's distress were measured using observational scales. A validated multiple choice questionnaire was used to measure parents' knowledge acquisition, whereas a visual analogue scale allowed parents to report their anxiety level prior to, during and after their stay in the recovery room. A chart review was conducted to collect data on children's postoperative pain, analgesic requirements and length of recovery. In order to assess the effect of the DVD on parents and their child, T-test, chi-square analyses and repeated measures ANOVAs were conducted among 105 dyads.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parents speaking, reading and communicating to their child in english or french
  • Parents who consented to participating in the study
  • Parents who had a child aged 3 to 10 years who underwent a day surgery of the ENT type (an adenoidectomy or an amygdalectomy or a combination of both) or of the dental type (a dental exam under general anesthesia or an extraction or a dental repair under general anesthesia) were part of the sampling

排除标准

  • The parents and the children who did not fit the eligibility criterias were excluded from the study.
  • The parents who completed the consent form and questionnaires before the day of the surgery and who did the pre-surgical preparation, but who did not accompany the child in the recovery room were not part of the study.
  • Also excluded, children who presented post-anesthetic complications (ex.: respiratory distress, hemorrhage, severe emotional distress, etc.).
  • Children presenting surgical complications (ex.: cardio-respiratory distress and hemorrhage) were also excluded from the study.

结局指标

主要结局

Parents' participation behaviors

时间窗: Post-treatment (In average, between 1 and 7 days following the intervention)

Video recordings were taken of parents and children during the child's stay in the recovery room, every 3 minutes for 15 seconds at a time. A maximum of six segments were randomly selected to capture a range of parental participation behaviors throughout their stay in the RR. Thus, the maximum duration of the recordings was 1 ½ minutes per parent (six observation periods x 15 seconds). Parents' participation behaviors were measured using an observational checklist, the Inventaire des conduites parentales (ICP) (Parental Behaviours Inventory), which includes different behaviors parents may have during a child's same-day surgery (Tourigny et al., 2005). The ICP is composed of 13 indicators divided into three categories; verbal information (i.e. providing information to child and answering child's questions), cognitive strategies (i.e. applying positive reinforcement and implementing coping strategies) and attitudes (i.e. showing the child affection and being close to the child).

次要结局

  • Children's distress in the recovery room (RR)(Post-treatment (In average, between 1 and 7 days following the intervention))
  • Children's analgesic requirements(Post-treatment (In average, between 1 and 7 days following the intervention))
  • Children's pain(Post-treatment (In average, between 1 and 7 days following the intervention))
  • Parents' knowledge acquisition(Post-treatment (In average, between 1 and 7 days following the intervention))
  • Parents' anxiety(Post-treatment (In average, between 1 and 7 days following the intervention))
  • Children's length of recovery(Post-treatment (In average, between 1 and 7 days following the intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie Chartrand

Assistant Professor

University of Ottawa

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