Frontline Nurse-Initiated Interventional Research: Use of Distraction Versus Oral Midazolam in Reducing Pediatric Perioperative Anxiety

Purpose: The purpose of this frontline nurse-initiated study was to examine if the use of interactive distraction (iPad™) was more or as effective in reducing preoperative anxiety, at parental separation and mask induction, as oral midazolam in children, four to twelve years old, undergoing outpatient surgery with a duration of 1-1/2 hours or less. The Seiden et al. (2014) study protocol was replicated in order to increase the body of evidence, but addressing their study limitations. In the Seiden et al. study, anesthesiologist researchers found no significant differences between interactive distraction and oral midazolam in pediatric perioperative patients. Preoperative anxiety is a global problem in pediatric surgical patients. Children often experience anxiety before outpatient surgical procedures during parental separation and at mask induction (De Querioz Siqueira et al., 2014; Kerimoglu, Neuman, Paul, Stefanov, & Twersky, 2013; Seiden et al., 2014). Currently, the most common treatment for pediatric preoperative anxiety is administration of oral midazolam, a benzodiazepine with undesired side effects of prolonged sedation, behavioral changes, and emergence delirium (Wetzel, 2016). The use of interactive distraction has not been sufficiently investigated in its effectiveness to minimize preoperative anxiety. Frontline perioperative nurses identified needs to: (1) evaluate non-pharmacological preoperative interventions, (2) enhance patient and family satisfaction, and, (3) promote patient safety during their outpatient surgical experiences. This is the first research study conducted by frontline nurses as previous studies have been conducted by anesthesiologists (De Querioz Siqueira et al., 2014; Seiden et al., 2014).

Methods: Single-blinded prospective comparative study design was used with randomized assignment to experimental iPad™ group and control oral midazolam group. The study was conducted at 403-bed urban pediatric medical center in the southwestern United States; Institutional Review Board approval was received. Research personnel in the Post-Anesthesia Care Unit (PACU) were blinded to study intervention. A total of 102 pediatric patients with 102 primary caregivers were recruited: 51 patients (mean age 6.8 years, 51% male) with 51 primary caregivers (mean age 35.7 years, 84% females) for iPad experimental group and 51 patients (mean age 6.9 years, 65% male) and 51 primary caregivers (mean age 35.3 years, 75% females) for oral midazolam control group. When the child participant picked the “dinosaur” card, the child received the control intervention of oral midazolam 15 to 45 minutes prior to parental separation. When the “robot” card was selected, the child was given an iPad™ mini with an age-appropriate gaming application one minute prior to parental separation to be continued through mask induction. Outcome measures included: (1) psychometrically established, modified Yale Preoperative Anxiety Scale (mYPAS; Jenkins, Fortier, Kaplan, Mayes, & Kain, 2014; Kain et al., 1997) at admission, parental separation, and mask induction, scored from nurse observations on activity, vocal, emotional expression, and arousal; (2) Pediatric Anesthesia Emergence Delirium (PAED; Bajwa, Costi, & Cyna, 2010; Sikich & Lerman, 2004) Scale upon awakening and 15 minutes post-awakening, scored from nurse observations in PACU; (3) parent’s perception of child’s anxiety at admission and separation, with Likert-style responses; (4) parent satisfaction with child separation, with Likert-style response; (5) time in minutes from PACU arrival to awakening, (6) time from PACU arrival to discharge home, and (7) assessment of post-hospitalization behavioral change in pediatric patients at 7 and 14 days postoperatively using Post Hospitalization Behavior Change Questionnaire for Ambulatory Surgery (PHBQ-AS; Jenkins et al., 2015). Data was analyzed using descriptive and inferential or non-parametric statistics (based on level of data) such as: Repeated Measures Analysis of Variance (RMANOVA) or Friedman Two-Way Analysis of Variance by Ranks or paired-sample t-tests for measurements within groups and multifactorial Analysis of Variance (ANOVA) or independent-samples Mann-Whitney U Test or independent-sample t-tests between groups.

Results: Children in the interactive distraction group demonstrated significantly lower mYPAS scores at times of parental separation and mask induction compared to oral midazolam group on activity, vocal, and arousal. On PAED scores at 15 minutes post-emergence, the iPad™ mini group had significantly lower scores (oral midazolam: 6.65 versus iPad™ mini: 3.3; p=0.001). Within groups, there were statistically significant differences on caregiver ratings of their child’s anxiety from admission to separation; all rated their child’s anxiety lower at time of separation. There were no statistically significant findings between groups on overall parent satisfaction. Times from PACU arrival to awakening were significantly lower (p = 0.007) in the distraction group. Times from PACU arrival to discharge home were statistically significant between groups (oral midazolam: 2.07 hours versus iPad™ mini: 1.66 hours; p< 0.0001). On 7-day PHBQ-AS responses, caregivers of children who received oral midazolam (n=12) reported higher percentages of poor appetite (25%) and temper tantrums (17%) while caregivers of children (n=9) in the distraction group reported more bad dreams (11%). By 14 days, the majority of PHBQ-AS responses returned to baseline except for continued temper tantrums (11%) and poor appetite (11%) in the oral midazolam group (n=9) and caregivers of the distraction group (n=9) said their children had more trouble getting to sleep (22%).

Conclusion: Use of interactive distraction was more effective in reducing preoperative anxiety and post-emergence delirium in pediatric outpatient surgery patients, 4 to 12 years old, when compared to the administration of oral midazolam preoperatively. Participants who used the iPad™ mini were extubated earlier and were discharged in less time than the oral midazolam group. Use of less sedative medications translates to decreased length of stay in the PACU which could result in increased productivity and financial savings for the medical center. Due to low response rates at 7 and 14 days on the PHBQ-AS, these findings cannot be generalized but can guide discharge teaching of caregivers on potential post-hospital behaviors. Interactive distraction was shown to be an effective alternative to oral midazolam in reducing preoperative anxiety and post-emergence delirium in pediatric surgical patients. Nurses worldwide can utilize this evidence to: (1) incorporate the age-appropriate and evidence-based use of interactive electronic distraction into their practice, (2) promote empowerment of families and patients through education on available options for reduction of preoperative anxiety, and (3) collaborate with various disciplines (i.e. anesthesiologists and child life specialists) to decide treatment options for preoperative anxiety. Frontline nurses are equipped with the skills and knowledge to identify needs for practice change and, with mentoring, can engage in the successful conduct of clinical research positively impacting patient outcomes.