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临床试验/NCT02286674
NCT02286674已完成不适用

Use of Handheld Audiovisual Devices to Treat Pediatric Preoperative Anxiety: A Randomized Control Trial.

McLaren Health Care2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Yale Preoperative Anxiety Score

研究概览

简要总结

Anxiety in children undergoing surgery is a central concern to both parents and healthcare workers, including nurses, surgeons, and anesthesiologists. It has been ranked by anesthesiologists as one of the top five important low-morbidity anesthesia outcomes (1). This study would determine whether such devices would decrease anxiety in children prior to induction of anesthesia for outpatient surgery. Two hundred children ages 2-12 will be enrolled.

详细描述

Anxiety in children undergoing surgery is a central concern to both parents and healthcare workers, including nurses, surgeons, and anesthesiologists. It has been ranked by anesthesiologists as one of the top five important low-morbidity anesthesia outcomes (1). Extensive research has been done characterizing, quantifying, and risk stratifying anxiety in this group as well as identifying a multitude of treatment options both pharmacological and nonpharmacological. Up to 60% of all children develop anxiety in the preoperative holding area and during anesthetic induction (2). The incidence can be much higher in some subpopulations. Preoperative anxiety has been attributed to number of causes including separation from parents and uncertainty about anesthesia, the procedure, and outcome (3).

Interestingly, anxiety prior to surgery has effects that extend into the intraoperative, acute recovery and subacute recovery timeframes. Patients with high levels of preoperative anxiety have been found to require greater anesthetic dosages (4). There is a higher incidence of emergence delirium in children with higher levels of preoperative anxiety (5, 6). These patients also have with a higher incidence of postoperative pain and require more analgesic medications (7). Furthermore, there are well documented maladaptive behavioral changes that can occur in 30-54% of children two weeks following surgery (8). These include generalized anxiety, nighttime crying, enuresis, separation anxiety, and temper tantrums. Twenty percent of these children maintain this behavior at 6 months and 7% persist at 1 year after the operation (9). High preoperative anxiety levels correlate with these behavior changes (2, 5, 8,10).

Many other interventions have been tried to decrease anxiety with varying success. Most are aimed at distraction. Music therapy appears to be therapist-dependent (12). Hand held video games appear to help decrease anxiety, even during induction (13). Even having clowns in the operating room at induction of anesthesia seems to help -- the study concluded that staff were quite resistant to maintaining the clown program (14). Interestingly, a small randomized controlled trial showed that parents distracting their children during induction with novel toys and books or blowing bubbles did not decrease anxiety (15).

Few studies have considered the use of tablets as distraction tools for children undergoing surgery. Low and Pittaway briefly described using an iPhone™ to distract 93 children in the preoperative period (16). However, the results are simply anecdotal. Patel et al. described a randomized control trial using hand held video games as a means of distraction compared to midazolam and a control group. They used the well validated and extensively used modified Yale Preoperative Anxiety Score (17) to measure anxiety levels. However, this study included parents being present at induction in all the groups, which may make the results difficult to apply at the majority of institutions, where parental presence is not used - our institution included (11).

In addition, premedication may be given to 50% of patients nationally, but it is not popular among parents (11,18). If the majority of practitioners do not use parental presence at induction, preoperative education programs are not yet in widespread use and half of patients are not premedicated, that leaves a significant portion of the population with little intervention for the time of separation and for time of induction of anesthesia. Finding an economical, efficient means to help decrease anxiety without high doses of premedication would be quite appealing.

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
None

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Outpatient surgery procedures
  • ASA I of II (No or mild systemic disease)
  • Parental/guardian ability to understand and willingness to sign written informed consent
  • Patient assent to use tablet, if they are randomized to the study group
  • Anesthetic plan includes sevoflurane inhalation induction as determined by the anesthesiologist

排除标准

  • Psychoactive medications (e.g. antipsychotics, mood stabilizers, anxiolytics, antidepressants, narcotics)
  • Diagnosed psychiatric disease
  • Developmental disabilities
  • History of photosensitive seizures
  • Patient requiring sedative or narcotic medications prior to induction of anesthesia, as determined by the anesthesiologist.
  • Parental/guardian inability to understand or refusal to sign written informed consent
  • Patient unwillingness or inability to use tablet
  • Anesthetic plan does not include sevoflurane induction, as determined by anesthesiologist.
  • Non English speaking patient and/or parent/guardian

结局指标

主要结局

Yale Preoperative Anxiety Score

时间窗: Patient enters operating room 1-32 minutes

1-32 minutes after #2

Yale Preoperative Aniety Score

时间窗: Placement of face mask on patient ofr anesthetic delivery 1-2 minutes

1-2 minutes after #3

次要结局

未报告次要终点

研究者

发起方
McLaren Health Care
申办方类型
Other
责任方
Principal Investigator
主要研究者

MCRI Staff

Michael Stein

McLaren Health Care

研究点 (2)

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