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Web-Based Tailored Intervention for Preparation of Parents and Children for Outpatient Surgery (WebTIPS)

Formative Evaluation and Randomized Controlled Trial

Fortier, Michelle A. PhD*†; Bunzli, Elizabeth BS*; Walthall, Jessica BS; Olshansky, Ellen PhD§; Saadat, Haleh MD; Santistevan, Ricci CCLS; Mayes, Linda MD; Kain, Zeev N. MD, MBA*†

doi: 10.1213/ANE.0000000000000632
Pediatric Anesthesiology: Research Report
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BACKGROUND: The purpose of this 2-phase project was to conduct a formative evaluation and to test the preliminary efficacy of a newly developed Web-based Tailored Intervention for Preparation of parents and children undergoing Surgery (WebTIPS).

METHODS: Phase 1 enrolled 13 children 2 to 7 years of age undergoing outpatient elective surgery and their parents for formative evaluation of WebTIPS. Parent participation focus groups are common in qualitative research and are a method of asking research participants about their perceptions and attitudes regarding a product or concept. In phase 2, children 2 to 7 years of age in 2 medical centers were assigned randomly to receive the WebTIPS program (n = 38) compared with children receiving the standard of care (n = 44). The primary outcome of phase II was child and parent preoperative anxiety.

RESULTS: In phase 2, parents reported WebTIPS to be both helpful (P < 0.001) and easy to use (P < 0.001). In phase 2, children in the WebTIPS group (36.2 ± 14.1) were less anxious than children in the standard of care group (46.0 ± 19.0) at entrance to the operating room (P = 0.02; Cohen d = 0.59) and introduction of the anesthesia mask (43.5 ± 21.7 vs 57.0 ± 21.2, respectively, P = 0.01; Cohen d = 0.63). Parents in the WebTIPS group (32.1 ± 7.4) also experienced less anxiety compared with parents in the control group (36.8 ± 7.1) in the preoperative holding area (P = 0.004; Cohen d = 0.65).

CONCLUSIONS: WebTIPS was well received by parents and children and led to reductions in preoperative anxiety.

From the *Department of Anesthesiology and Perioperative Care, University of California, Irvine School of Medicine, Irvine, California; UCI Center on Stress & Health, Irvine, California; Department of Anesthesiology, Yale School of Medicine, New Haven, Connecticut; §School of Nursing Science, University of California, Irvine, Irvine, California; Child Life Department, Children’s Hospital of Orange County, Orange, California; Child Study Center, Yale University, New Haven, Connecticut.

Accepted for publication November 3, 2014.

Funding: This work was funded by National Institutes of Health grant 5R01HD056104-02 (Zeev N. Kain, MD, principal investigator).

The authors declare no conflicts of interest.

Reprints will not be available from the authors.

Address correspondence to Michelle A. Fortier, PhD, Department of Anesthesiology and Perioperative Care, University of California, Irvine, 505 S. Main St., Suite 940, Orange, CA 92868. Address e-mail to mfortier@uci.edu.

Preoperative preparation for children and families appears to have become a lower priority in the face of health care cost-containment efforts. The majority of pediatric hospitals offered behavioral preparation for children undergoing surgery in the 1990s,1 and research has shown that the more extensive the preparation, the greater the impact in reducing preoperative anxiety.2 However, currently, very few hospitals and ambulatory surgery centers offer extensive behavioral preparation of children, and those that do, mostly prepare children on the day of surgery. This approach of preparing children on the day of surgery does not allow children the necessary time to learn coping strategies and develop self-efficacy to adequately manage preoperative anxiety. Moreover, in a busy perioperative setting, it is simply not possible to adequately prepare each child-parent dyad on the day of surgery because of the limited time providers have to interact with children in the preoperative area.3

Accordingly, as part of a National Institute of Child Health and Human Development--funded project, our group developed the Web-based Tailored Intervention for Preparation of parents and children undergoing Surgery (WebTIPS). This tailored program includes a fully animated children’s Web site comprising education, skills training, and interactive games to prepare children for what to expect before, during, and after surgery and to teach coping strategies to manage perioperative anxiety and pain. WebTIPS also includes a parent Web site that uses a variety of modalities to provide parents with information, skills training, anxiety management, and modeling techniques to prepare parents for the day of surgery. The reader is directed to the first article in this series for a detailed description of the development and content of WebTIPS.4

Once developed, our group conducted a 2-phase evaluation of this novel intervention, and the purpose of this article was to present the results of this evaluation process. Phase 1 consisted of formative evaluation (usability and feasibility) with parents of children who had undergone surgery previously and parents of children who were scheduled for an upcoming outpatient surgery. Phase 2 consisted of a small-scale randomized controlled trial (RCT) to examine the efficacy of WebTIPS in reducing anxiety in a sample of parents and children before outpatient surgery. It was hypothesized that WebTIPS would result in significantly less preoperative anxiety in both children and parents compared with children receiving standard of care perioperative management, as measured by the modified Yale Preoperative Anxiety Scale (mYPAS) and State-Trait Anxiety Inventory, respectively.

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METHODS

IRB approval was obtained from Children’s Hospital of Orange County and Yale-New Haven Children’s Hospital. All parents provided written consent, and children provided assent when appropriate.

WebTIPS is an empirically based, tailored, innovative, Web-based preoperative preparation program for both children who will undergo surgery and their parents. WebTIPS was designed for children 2 to 7 years of age and includes a fully animated children’s Web site, as well as a multimedia parent Web site. The children’s Web site is tailored based on children’s trait anxiety and type of surgery and includes information provision, modeling, and coping skills. The parent Web site is tailored based on parent baseline anxiety, coping style, pain management attitudes, and preferences for sedative premedication and parental presence during induction of anesthesia (PPIA) and includes information provision and coping skills training. Both Web sites are divided into 4 sections covering the perioperative period: home (preoperative), preoperative holding area and anesthesia induction and surgery, postanesthesia care unit (PACU), and home (postoperative). WebTIPS is also structured to allow for tailoring based on hospital and health care provider preferences and the standard of care (e.g., use of sedative premedication and parental presence in the operating room [OR]). WebTIPS was designed to complement (rather than replace) the standard of care for surgical preparation. The reader is referred to part 1 of this series in this issue of Anesthesia & Analgesia for a detailed description of WebTIPS.4

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Phase 1: Formative Evaluation

A focus group is common in qualitative research and is a method of asking research participants about their perceptions and attitudes regarding a product or concept. Focus groups are useful to generate qualitative data because participants can stimulate discussion among one another in addition to the interview questions that are asked.

Children 2 to 7 years of age undergoing outpatient elective surgery and their parents were enrolled in this phase of the study (n = 13). Seven parent-child dyads were enrolled after having recently undergone surgery (postoperative group), and 6 parent-child dyads were enrolled 5 to 10 days before undergoing surgery (preoperative group). Exclusion criteria included developmental delays, premature birth (<32 weeks), and ASA physical status ≥3. Parents were given instructions to access WebTIPS at home and the content/usability measure after completion of the intervention. All parents participated in an individual interview and a focus group with 2 interviewers and 2 to 3 other parents, which were audio recorded. Parents rated the usability and likeability of each WebTIPS module on a 5-point Likert-type scale (0–4), with higher scores indicating more positive responses (very helpful or very useful). Participants were also asked open-ended questions regarding the content and ease of navigation. As part of the feasibility/usability testing, parents also participated in a 1-on-1 interview with the researchers to ask additional questions and complete quantitative usability/likeability measures about WebTIPS.

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Data Analysis

The sample size for formative evaluation was determined by theoretical saturation, which is determined by review of data collected such that new information is no longer being generated.5 All audio recordings were transcribed, and the text files were uploaded into Dedoose, a Web-based mixed-methods analysis program. Data were analyzed in 2 ways: (1) content analysis of the audio recordings using Dedoose to identify narrative themes, and (2) statistical analysis of quantitative data from the content/usability measure. Using content analysis, we identified analytical categories, as evidenced by salient verbatim quotes from the transcripts. Dedoose was useful for organizing these categories with the salient quotes (or raw data) to support the categories. After performing content analysis of the data 2 times, indexed categories were refined and reduced, and frequencies of responses within each category were calculated. Quantitative data from content/usability measure were coded and analyzed using SPSS. Nonparametric 1-sample Wilcoxon signed-rank tests were performed to test whether parent ratings were different from the midpoint of the scale. Median values and interquartile ranges are reported.

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Phase 2: Preliminary RCT

Participants included 82 English-speaking parent-child dyads scheduled to undergo outpatient surgery and general anesthesia at Children’s Hospital of Orange County or Yale-New Haven Children’s Hospital between August 2011 and August 2012. Inclusion criteria included the following: children ASA classification 1 and 2 (children in good health) between 2 and 7 years of age, born at ≥32 weeks gestational age, and without any developmental delays or cognitive impairment. Children were excluded from participation if they were ASA status ≥3, were receiving services for developmental delay or cognitive impairment that would preclude participating in WebTIPS and may impact surgical recovery, or were non-English speaking, given that WebTIPS is currently available only in English. Children with previous experience with surgery and/or anesthesia were not excluded from participation.

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Measures

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Child Temperament: Emotionality Activity Sociability Temperament Survey

The Emotionality Activity Sociability Temperament Survey (EAS-TS) is a tool used to assess temperament of the child through parental report, and the reader is referred to previous articles detailing its psychometric properties.6–8

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Parent Coping: Miller Behavioral Style Scale

The Miller Behavioral Style Scale assesses parental coping style and identifies individuals as information seekers (monitors) or information avoiders, and distracters (blunters). This measure has excellent reliability and validity.9

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Modified Yale Preoperative Anxiety Scale

The Modified Yale Preoperative Anxiety Scale (mYPAS) is a well-validated observational measure of children’s preoperative anxiety that is widely used in experimental protocols.10,11 To obtain interrater and intrarater reliability for the current study, 3 research associates (RAs) were trained using a standardized protocol developed within the University of California Irvine Center for Stress and Health. In the first phase of training, raters learn the mYPAS manual, which describes the purpose, administration, and scoring of the measure. In the second phase, raters in training and previously trained raters score videos as a group and discuss their scoring decisions. In the final phase, raters in training score videos alone and have their scores compared with previously trained raters’ scores. Any discrepancies between scores are discussed. This procedure is continued until raters in training achieve intrareliability and interreliability scores (κ) of ≥0.80.

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Parent Anxiety: State-Trait Anxiety Inventory

The State-Trait Anxiety Inventory is a widely used self-report assessment instrument for adults that measures trait and state anxiety, and the reader is referred to previous publications detailing its psychometric properties.12,13

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Pediatric Anesthesia Emergence Delirium

Pediatric Anesthesia Emergence Delirium is a validated 5-item measure of emergence delirium that assesses specific behavioral components that are distinct from pain.14 Each of the 5 items is rated on a 0 to 4 scale and summed to provide a continuous score from 0 to 20. Higher scores are associated with increased emergence delirium.

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Other Outcome Data

Intraoperative and PACU data were abstracted from medical records, including analgesics administered, length of surgery, length of PACU stay, and nurse-rated pain severity (0–10 numeric rating scale).

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Study Procedures

To ensure external validity of this study, we chose not to standardize any of the clinical management of the participants. That is, all participants of this study were managed based on the standard of care of the particular institution and the particular health care provider.

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Preoperative Period

Interested participants provided informed consent and were assigned to either the WebTIPS or the standard of care group based on a computer-generated random number sequence. Allocation concealment was obtained using the computer generation protocol. Although it was not possible to mask participants or health care providers to group assignment, the RAs responsible for data collection were masked. Specifically, RAs who did not recruit patients were responsible for all participant phone calls during the recruitment process. In addition, to maintain masking on the day of surgery, the recruiting RAs were given a blank envelope to be given to the health care provider that either contained the patient-specific WebTIPS information or a blank “control” slip of paper. Providers were advised to use their usual clinical care, which may include preoperative midazolam, child life preparation, PPIA, and any other routine intervention.

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WebTIPS Group

Before surgery, families were provided with instructions via e-mail on how to access WebTIPS from home. The e-mail included a direct link to the Web site, as well as log in information. Parents were supplied with a unique password to enable them access to the WebTIPS Web site as many times as desired starting 7 days before surgery and until 7 days after surgery. A research e-mail account was established to allow parents to e-mail the researchers with any questions or problems. When possible, anesthesiologists were also provided with output of child and parent data on the day of surgery. The output of the clinician component included the child’s favorite interests and activities (to be used for distraction) and summary information regarding anxiety and coping style of the parent, parent preference for PPIA, and sedative premedication. Children in the WebTIPS group received the standard of care along with the WebTIPS intervention.

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Standard of Care Group

Participants in the standard of care group were provided with the usual care in the institution.

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Day of Surgery

In the preoperative holding, both groups of children and parents were handled based on the standard of care of each of the 2 institutions that were part of this study. During the intraoperative and postoperative periods, the anesthetic and medical management was conducted as the standard of care and was not controlled for the study groups. A trained RA assessed child anxiety (mYPAS) at 3 time points: separation to the OR, entrance to the OR, and introduction of the anesthesia mask to the child. Parents provided self-report ratings of anxiety in the preoperative holding area and upon separation to go to the OR. The RAs obtained data in the PACU, including emergence delirium, analgesic consumption, pain ratings, and length of stay.

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Statistical Analysis

Power analysis was conducted based on expected differences in mean anxiety scores (mYPAS) at induction of anesthesia to determine necessary sample size. Anticipating an effect size of 0.5 to 0.6 based on our previous work,15 it was determined that a minimum of 35 children was necessary per group with power set at 0.80 and an α of 0.05 to detect group differences in children’s anxiety at anesthesia induction. Descriptive analyses, including frequencies, means, and medians, were calculated to explore baseline and demographic variables of the study sample as a whole and for the 2 study groups separately. Independent sample t tests, Kruskal-Wallis nonparametric analysis of variance (ANOVA), and χ2 analyses were conducted to examine group differences in baseline and demographic variables. Independent sample t tests and repeated-measures ANOVA were used to examine group differences in preoperative anxiety and the effects of group assignment on children’s anxiety over time. Cohen d was calculated as a measure of effect size. It is generally accepted that a small effect size is 0.20, a medium effect size is 0.50, and a large effect size is 0.80.16 Data presented as mean ± standard deviation satisfied the Kolmogorov-Smirnov (K-S) test with Lilliefors correction (P > 0.07) unless otherwise noted in Table legends. Skewed data are presented as median and interquartile range (75%–25%).

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RESULTS

Phase 1: Formative Evaluation

Parents who participated in formative evaluation were primarily mothers (92.3%) and non-Hispanic Caucasian (76.9%). Parents reported a mean age of 32.0 ± 5.0 years and 13.8 ± 2.3 years of education. The children of parent participants were primarily (84.6%) undergoing ear-nose-throat procedures (tonsillectomy and adenoidectomy were the most frequent surgery types).

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Content Analysis

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Parent Analysis

After analysis of all transcripts, we identified several dominant responses among focus group participants (Distraction to Reduce Children’s Preoperative Anxiety; Relaxation Techniques for Parent Anxiety; Waking up in the PACU; Exposure to the Anesthesia Mask; Recovery from Surgery; and Ease of Use). In cases in which a consistent negative response was identified to a particular item on WebTIPS, revisions were made to the Web site.

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Child Analysis

Eleven parents reported that their children used the child Web site, with 9 parents (81.8%) indicating that their children were engaged and 2 parents (18.20%) reporting that their children were not engaged, both of whom acknowledged their children were younger than the intended age range.

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Usability Analysis

Median ratings for the helpfulness measurement were significantly greater than the midpoint (“moderately helpful”) of the scale for each of the modules: home before surgery (3.50 [1.0], P = 0.029), waiting area and induction (4.00 [1.0], P =0.002), PACU (3.50 [1.0], P = 0.004), and home after surgery (4.00 [1.0], P = 0.030). Mean ratings of ease of use for all modules of WebTIPS were significantly greater than the midpoint (“neither easy nor difficult”) of the scale for each of the modules: home before surgery (4.00 [0], P = 0.001), waiting area and induction (4.00 [0.75], P = 0.002), PACU recovery (4.00 [0], P = 0.001), and home after surgery (4.00 [0], P = 0.006).

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Phase 2: Randomized Controlled Trial

Participants were recruited and data were collected from August 2011 through August 2012, at which point the proposed sample size had been enrolled (Fig. 1). There were no differences in demographic or baseline data between children and parents across the study sites, with the exception of race/ethnicity, with a larger percentage of Hispanic/Latino children in California (40%) compared with Connecticut (17%) (P = 0.01). Across sites, 71% of children received sedative premedication and 22% of participants received PPIA; these practices did not differ between the experimental groups (Table 1). In terms of intervention adherence, the majority of families in the WebTIPS group accessed all modules of the preparation program. Each Web site (parent and child) has 4 modules. All 38 parents accessed modules 1 and 2 of the parent Web site. One parent did not access modules 3 and 4, and one parent did not access module 4. With regard to the child Web site, all families accessed modules 1 through 3, whereas 7 families did not access module 4.

Table 1

Table 1

Figure 1

Figure 1

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Intraoperative Period

All intraoperative analgesics were converted to morphine equivalents, and independent sample t tests revealed no significant differences between the WebTIPS and control groups (P = 0.85). Intraoperative analgesic data are presented in Table 2.

Table 2

Table 2

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Primary Outcome—Preoperative Anxiety

Independent sample t tests revealed that children in the WebTIPS group experienced significantly lower anxiety at entrance to the OR (t(72) = 2.5, P = 0.02) and introduction of the anesthesia mask (t(72) = 2.7, P = 0.01) compared with children in the standard of care group (Table 3). There were no significant site differences in children’s anxiety scores at entrance to the OR (P = 0.66) or mask introduction (P = 0.90).

Table 3

Table 3

A repeated-measures ANOVA revealed a significant effect of time (F(2,72) = 11.9, P < 0.001), suggesting that anxiety increased significantly across the preoperative period. There may also have been an interaction of time and group (F(1,72) = 3.8, P = 0.05), indicating that for the WebTIPS group, anxiety stayed relatively stable from separation to entrance to the OR, increasing only at introduction to the anesthesia mask. Conversely, children in the standard of care group experienced a significant increase in anxiety at each of the 3 time points (Fig. 2).

Figure 2

Figure 2

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Preoperative Anxiety—Parents

Independent sample t tests revealed that although no differences emerged with State-Trait Anxiety Inventory scores at separation to the OR (P = 0.26), parents in the WebTIPS group experienced significantly lower anxiety in the preoperative holding area (t(78) = 2.43, P = 0.02) compared with parents in the standard of care group (Table 3). There were no site differences in parent’s anxiety scores in the holding area (P = 0.80) or at separation to the OR (P = 0.30).

A repeated-measures ANOVA revealed a significant effect of time (F(1,77) = 50.6, P < 0.001), suggesting that parental anxiety increased significantly across the preoperative period. There was no significant interaction of time and group (P = 0.71), suggesting that the increase in anxiety between the experimental groups was similar, despite parents in the WebTIPS groups experiencing significantly less anxiety in the preoperative holding area.

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PACU Period

Children in the WebTIPS group may have experienced significantly lower emergence delirium compared with children in the control group on the Pediatric Anesthesia Emergence Delirium test [t(75) = 2.01, P = 0.04, Cohen d = 0.45, 95% confidence interval = 0.06–2.71] (Table 4). No differences were observed in nurse-rated pain severity (0–10 numeric rating scale) or analgesics administered in the PACU between groups (Table 4).

Table 4

Table 4

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DISCUSSION

Under the conditions of this small-scale preliminary trial, we demonstrated that a Web-based tailored preoperative preparation program is an effective intervention for reducing children’s and parents’ anxiety before surgery and may be effective for reducing emergence delirium after surgery. Also, although results did not reach statistical significance, PACU stay for children in the WebTIPS group was shorter by 17 minutes compared with the control group, which is clinically significant given that the median PACU stay for both groups was just >60 minutes. It is important to note that there were no differences in either baseline or outcome data between hospitals in this multisite study.

WebTIPS is unique in a number of ways. First, it is a tailored intervention that includes not only surgical characteristics of the child in the tailoring matrix but also personality and baseline characteristics of both parents and children. Tailored interventions are more refined and complex than targeted interventions and can be customized to an individual’s situation and needs.17–22 More specifically, computer tailoring is a relatively new technique that has gained popularity in health care during the past decade.19,20,22–24 Computer tailoring has been shown to efficiently convey information in a number of health areas.18,20,25 Second, there is a move in health care to incorporate health information technology to increase access to patients, increase patient engagement in health care, and improve health care provider--patient communication and decision making to minimize the gap between evidence and practice.26–28 There is empirical evidence that the use of computer-based decision support, for example, can positively impact management of pain29 and can lead to significant improvements in clinical care, including use of appropriate treatment.29–32 Moreover, data from the Pew Internet and American Life Project revealed a dramatic increase in Internet usage over the past 2 decades and indicated that as of 2014, >87% of American adults and 95% of teens use the Internet.33 Given the limited time that health care providers are able to spend with patients on the day of surgery,3 which is when the majority of preoperative preparation is offered, means of widespread access to patients before surgery is needed, and Web-based interventions fill this gap. Third, WebTIPS is grounded in empirical evidence and is directed at outcomes that are measurable and clinically significant to children, parents, and health care providers.

This preliminary efficacy study of WebTIPS suggests that it is a well-accepted, feasible intervention to implement and demonstrate positive impacts on patient-reported and clinical variables of interest in the perioperative setting. It will also be important to examine postoperative data, namely postoperative pain and analgesic administration in the home setting. In addition, behavioral recovery after surgery is an important domain, given that preoperative anxiety and emergence delirium have direct associations with postoperative behavioral recovery.34 Accordingly, postoperative pain, analgesic administration at home, and behavioral recovery will be assessed in a future large-scale effectiveness RCT across multiple institutions. In addition, a cost-benefit analysis is needed. Given that WebTIPS is currently capable of being modified to be hospital specific or surgery center specific (e.g., insert hospital logo, modify content to be consistent with hospital practice), it does not require any additional hospital visits to be administered, and can be accessed independent of health care provider administration, we expect WebTIPS to prove more cost-effective than current means of behavioral preparation. That said, because WebTIPS is associated with software-related costs, an official cost-benefit analysis is needed. Finally, increasing the interactivity of the program, such as by allowing users to ask real-time questions, may be an important avenue to consider for future Web-based preparation programs.

Several methodological issues related to this article have to be addressed. First, we decided a priori to conduct this trial in 2 institutions to test WebTIPS over a variety of surgical procedures and practices of parental presence and sedative premedication. Indeed, we have demonstrated that WebTIPS is effective in the context of the conditions of the trial. Although this allowed a high level of external validity, it does raise the possibility of confounding effects of various anesthetic drugs on variables such as emergence delirium. Nonetheless, because patients were randomized, it is likely that any such possible confounding effects were eliminated. The next steps in this program of research are to implement a large-scale trial of WebTIPS to examine a wider range of behavioral and clinical outcomes, including PACU recovery time, postoperative pain management at home, and family and health care provider satisfaction.

In addition, although a strength of WebTIPS is that it includes preparation in management of pain after surgery, the present study was not powered to examine the impact of the intervention on postoperative pain and analgesic administration as outcomes. Moreover, a larger trial would allow for examination of the effects of adherence to the intervention on perioperative outcomes, as well as determination of the effective components of WebTIPS. Finally, it is not known to what extent families may have sought out additional, external sources of preparation information via the Internet and what impact this might have had on the outcomes.

In conclusion, WebTIPS was shown to result in improved immediate behavioral outcomes, including decreased preoperative anxiety in parents and children and decreased emergence delirium in children undergoing surgery. WebTIPS was well received overall by families and has widespread applicability and access, particularly given the increasing rates of Internet usage among adults and children. WebTIPS has the potential to transform the delivery of behavioral interventions for children and families undergoing surgery, will likely reduce hospital costs, and can reach a broad health care provider and patient base. WebTIPS capitalizes on use of the Web, which is a medium that the majority of families in the United States use regularly. In addition, this novel program uses a variety of multimedia components (e.g., animation, motion graphics, video, and audio), which resulted in an engaging program from which families could easily learn preparation skills needed for preoperative anxiety and postoperative pain management in real time and repeatedly, which we believe contributed to the success of WebTIPS. Our goal was that WebTIPS become the standard of care in hospitals across the country.

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DISCLOSURES

Name: Michelle A. Fortier, PhD.

Contribution: This author helped design and conduct the study, analyze the data, and write the manuscript.

Attestation: Michelle A. Fortier has seen the original study data, reviewed the analysis of the data, and approved the final manuscript.

Name: Elizabeth Bunzli, BS.

Contribution: This author helped collect and analyze the data.

Attestation: Elizabeth Bunzli approved the final manuscript.

Name: Jessica Walthall, BS.

Contribution: This author helped collect and analyze the data.

Attestation: Jessica Walthall approved the final manuscript.

Name: Ellen Olshansky, PhD.

Contribution: This author helped analyze the data and write the manuscript.

Attestation: Ellen Olshansky approved the final manuscript.

Name: Haleh Saadat, MD.

Contribution: This author helped design and conduct the study.

Attestation: Haleh Saadat approved the final manuscript.

Name: Ricci Santistevan, CCLS.

Contribution: This author helped design and conduct the study and helped write the manuscript.

Attestation: Ricci Santistevan approved the final manuscript.

Name: Linda Mayes, MD.

Contribution: This author helped design and conduct the study and helped write the manuscript.

Attestation: Linda Mayes approved the final manuscript.

Name: Zeev N. Kain, MD, MBA.

Contribution: This author helped design and conduct the study, analyze the data, and write the manuscript.

Attestation: Zeev N. Kain has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

This manuscript was handled by: James A. DiNardo, MD.

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