Trial Outcomes & Findings for An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS) (NCT NCT03730259)

The enrollment number in the Protocol Section and numbers in the Participant Flow Milestones reflect the number of parent-child dyads.

since we are reporting child and parent separately

Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: holding, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 18 items in five domains of behavior indicating anxiety in young children (Activity=a, Vocalization=b, Emotional expressivity=c, State of arousal=d, and Use of parents=e). For each category the child is scored from 1-4 (however in vocalization it is 1-6). For the purposes of this study, the study team used the short form (SF), thus eliminating the last domain- use of parent. The mYPAS total score is a sum of all categories for all time points, with higher scores indicating greater anxiety. mYPAS scoring: Sum (((a/4)+(b/6)+(c/4)+(d/4)+(e/4))/5)\*100 Scores range from 23.33 to 100. SF scoring: Sum (((a/4)+(b/6)+(c/4)+(d/4))/4)\*100 Scores range from 22.92 to 100.

Emergence status will be assessed through the Pediatric Anesthesia Emergence Delirium Scale (PAED). Items rated on a 5-point rating scale from 0 ("extremely") to 4 ("not at all"). The PAED rating scale consists of five psychometric items ("child makes eye contact with the caregiver", "child's actions are purposeful," "child is aware of the surroundings," "child is restless," "child is inconsolable") for the measurement of ED in children. Items are summed up for a total score that directly increases with the degree of emergence delirium. Scores range from 0-20. Higher total score represents greater degree of emergence delirium.

Postoperative pain intensity will be assessed through the 15-item Postoperative Pain Measure (PPPM) in which parents can indicate the presence or absence of each of the 15 behavioral indicators of pain by selecting either "Yes" or "No" for each question. In this scale, "0: Yes" and "1: No." A total score is achieved by summing all 15 items--A score of 6 or higher indicates clinically significant pain. The questions on this scale are specific to postoperative pain (e.g. Refuse to eat? Eat less than usual?).

Parents will assess specific behaviors in the postoperative period through the Post-Hospitalization-Behavior-Questionnaire for Ambulatory Surgery (PHBQ-AS). This measure consists of 11 items and six categories of anxiety: General Anxiety, Separation Anxiety, Sleep Anxiety, Eating Disturbances, Aggression Against Authority, and Apathy/Withdrawal. Each item is scored on a 5-point Likert-type scale with responses ranging from "Much less than before" to "Much more than before." Each item uses a 5-point Likert scale: 1 = Much less than before, 2 = Less than before, 3 = Same as before, 4 = More than before, 5 = Much more than before. The original PHBQ-AS scoring is the mean (average) of the 11 items - not a summed raw score. The possible range of the mean = 1.0 to 5.0. Interpretation: 3 = no behavioral change (baseline) \> 3 = maladaptive / negative behavioral change (e.g., more anxiety, more sleep disturbance, etc.) \< 3 = improvement compared with baseline (e.g., fewer anxious beh

Parents are asked to report on the child's health related quality of life using the pediatric quality of life questionnaire (PedsQL). The measure has sub-scales Physical Functioning (8 items) Emotional Functioning (5) Social Functioning (5) School Functioning (5). Each item asks "In the past 1 month, how much of a problem has your child had with…?" Response scale (for most forms) is 0 = Never a problem, 1 = Almost never, 2 = Sometimes, 3 = Often, 4 = Almost always a problem (later transformed to 0-100). Response options (raw): 5-point Likert 0-4 (0=Never … 4=Almost always) Map to 0-100 where higher = better HRQoL 5-point form: 0→100, 1→75, 2→50, 3→25, 4→0 3-point form: 0→100, 2→50, 4→0 Sub-scales and summaries (all 0-100): Physical (8 items) → 0-100; Emotional (5) → 0-100; Social (5) → 0-100; School (5) → 0-100; Total Score (all items) → 0-100 Higher transformed scores on the scale suggest a better health related quality of life.

Only the Trait section of the questionnaire is administered to parents to assess their self-reported anxiety. Items rated on a 4-point Likert Scale from 1 ("Almost Never") to 4 ("Almost Always").Higher scores suggest higher levels of anxiety. Total scores for anxiety range from 20 to 80. Higher scores denote higher levels of anxiety.

Given that WebTIPS changes anxiety and pain, expedites the recovery process, and provides healthcare providers with data to personalize and assist the entire surgical process,we are interested in the parent satisfaction outcomes. Parent satisfaction scores will be evaluated through the National Research Council (NRC) Picker satisfaction survey. The questions on this survey evaluate satisfaction with the most recent hospital stay (e.g. Did the providers give you enough information about each choice?). Each question presents a multiple choice response of either "Yes-definitely, Yes-somewhat, and No." For each question, positive scores transformed as a percentage will represent how many participants filled out the most satisfied response. Score ranges from 0-48. Higher scores represent higher satisfaction

Nurses blinded to treatment conditions will assess children's pain through the Faces, Legs, Arms, Cry, and Consolability (FLACC) pain scale every 15 minutes in the post-anesthesia care unit. In each of the categories (faces, legs, arms, cry, and consolability) the behaviors are scored from 0 to 2. By summing the result of all five categories, the FLACC scale yields a total score of 0-10 with higher scores indicating greater pain.

Pain intensity will also be measured through the FPS-R. Parents will assess children's pain through the Faces Pain Scale-Revised (FPS-R). The FPS-R is scaled from 0-10 using diagrams of cartoon faces expressing pain with scoring increments of 0, 2, 4, 6, 8, and 10, in which '0' = 'no pain' and '10' = 'very much pain.' Children are asked to pick the face and corresponding number that best describes their pain. Higher scoring increments on the scale suggest greater pain.