Use of Handheld Audiovisual Devices to Treat Pediatric Preoperative Anxiety
Condition: Pediatric Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      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. Half would be in the control group, which would receive standard care. Half would
      be in the study group, which would receive a tablet device in the preoperative holding area
      and would be allowed to watch TV or movies from a preloaded list until they are given
      anesthetic gases in the operating room. The subjects would be observed for outward signs of
      anxiety and scored using a well validated and well used anxiety scale, the modified Yale
      preoperative anxiety scale, at several points in time prior to induction of anesthesia. The
      expected total study length is 6 months based on the current number of pediatric cases at the
      study site.
    

Intervention name(s): Tablet (Audio/Visual Device)
Intervention type(s): Other
Intervention description(s): Subjects will be given a tablet to use before surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mYpas; anxiety; distraction; inhalation induction