Use of Handheld Audiovisual Devices to Treat Pediatric Preoperative Anxiety



Status:Recruiting
Conditions:Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:2 - 12
Updated:4/21/2016
Start Date:November 2014
End Date:January 2017
Contact:Michael Stein, DO
Email:michael.stein@mclaren.org
Phone:517-975-7293

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

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.

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.

Inclusion Criteria:

1. Ages 2-12

2. Outpatient surgery procedures

3. ASA I of II (No or mild systemic disease)

4. Parental/guardian ability to understand and willingness to sign written informed
consent

5. Patient assent to use tablet, if they are randomized to the study group

6. Anesthetic plan includes sevoflurane inhalation induction as determined by the
anesthesiologist

Exclusion Criteria:

1. Psychoactive medications (e.g. antipsychotics, mood stabilizers, anxiolytics,
antidepressants, narcotics)

2. Diagnosed psychiatric disease

3. Developmental disabilities

4. History of photosensitive seizures

5. Patient requiring sedative or narcotic medications prior to induction of anesthesia,
as determined by the anesthesiologist.

6. Parental/guardian inability to understand or refusal to sign written informed consent

7. Patient unwillingness or inability to use tablet

8. Anesthetic plan does not include sevoflurane induction, as determined by
anesthesiologist.

9. Non English speaking patient and/or parent/guardian
We found this trial at
1
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Lansing, Michigan 48910
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Lansing, MI
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