The goal of this randomized trial is to examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) in reducing anxiety and improving the recovery process in children undergoing surgery. Two hospitals and all parent-child dyads will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed intervention with short message service (SMS), while the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and perioperative pain. The aims of this study are to: Primary aim: Quality of Clinical Care: Determine whether and to what extent WebTIPS is more effective than an attention control intervention in reducing preoperative anxiety among children ages 1-12 years old undergoing anesthesia and outpatient surgery. Secondary aims: Quality of Clinical Care: 1. Examine the impact of WebTIPS on Post-Anesthesia care unit based postoperative clinical recovery parameters, such as pain and emergence delirium. 2. Examine the impact of WebTIPS on home-based postoperative clinical recovery parameters such as pain, new onset behavioral changes and return to normal daily activity over 2 weeks. 3. Determine if the use of WebTIPS reduces parental preoperative anxiety. Experience of Care: Examine the effects of WebTIPS on parental satisfaction with the overall experience of the surgical episode.
The proposed two-arm single blind, randomized trial of two children's hospitals: CHOC Children's (CHOC) and Seattle Children's Hospital. Approximately 620 patients and their families will be recruited in total. This study will examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) aimed at reducing anxiety and improving the recovery process in children undergoing surgery via parent and child interactive preparation modules. Each study site will have a permuted block group assignment stratified by surgical severity. Within each surgical severity group, patients and their families will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed interactive intervention with short message service (SMS). Conversely, the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and postoperative pain. Objective measures of children's preoperative anxiety and postoperative recovery will be collected prior and during the experimental period. Patients and their parents in the intervention group will learn through the internet and mobile platforms that implementing strategies and ways to adjust behavior, such as distraction and medical reinterpretation, directs the child's attention away from their own distress or fear. This group will also have access to a SMS messaging system. Child's anxiety (assessed through the modified Yale Preoperative Anxiety Scale-mYPAS) during induction will be assessed at two points, a) entering the operation room (OR) and b) introduction of the anesthesia mask to the child. If parents accompanied the child into the OR, their anxiety will be rated as they leave the OR (state-trait anxiety inventory-STAI). Also, parents answer baseline questionnaires aimed at capturing demographics (e.g. age, sex), as well as parental coping (through the Miller behavioral style scale), and child temperament (through the emotional, activity, and shyness temperament survey). In the holding area and separation, a research assistant who is blinded to group assignment will rate child anxiety (mYPAS) and ask parent anxiety (STAI), and also assess child/parent anxiety at separation to the OR (mYPAS, STAI). Postoperative analgesic consumption, behavioral and recovery measures will also be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,274
A Tailored Internet-based Preparation Program for Perioperative Anxiety and Pain (WebTIPS) is developed using the conceptual framework of the Triple Aim that evaluates the intervention within the context of clinical efficacy, improved child and parent experience, and reduced resource utilization during the surgical episode. WebTIPS aims at reducing perioperative anxiety and pain in children via an internet-based platform with short message service (SMS).
CHOC Children's Hospital
Orange, California, United States
Seattle Children's Hospital
Seattle, Washington, United States
Assess Children's Domains of Behavior Indicating Anxiety [Activity, Emotional Expressivity, State of Arousal, Vocalization and Use of Parents]
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.
Time frame: Day of surgery (Holding Area, Separation, Entrance to operating room, and placement of the anesthesia mask)
Assess Pediatric Anesthesia Emergence Delirium [Emergence Status and Psychometric Evaluation in Children]
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.
Time frame: Baseline (Post-Anesthesia Care Unit)
Change in Children's Pain Intensity Using the Postoperative Pain Measure (PPPM)
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?).
Time frame: Days 1-7 after surgery, once a day (in the evening)
Change in Children's Postoperative Maladaptive Behaviors Using the Post-Hospitalization-Behavior-Questionnaire for Ambulatory Surgery
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
Time frame: Day 5, 7, 14 after surgery
Change in Children's Return to Normal Activity Using the Pediatric Quality of Life (PedsQL) Questionnaire
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.
Time frame: The evening of day 5 after surgery
State-Trait Anxiety Inventory (STAI) (Parent Self-report)
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.
Time frame: Day of surgery (Holding area, and upon separation to the operating room)
Assess Parent Satisfaction Outcomes Using the National Research Council (NRC) Picker Satisfaction Survey
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
Time frame: Day 1 after surgery
Children's Postoperative Pain Using the Faces, Legs, Arms, Cry and Consolability Pain Scale (FLACC)
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.
Time frame: First nurse rating upon arrival to the post-anesthesia care unit
Change in Children's Pain Intensity Using the Faces Pain Scale-Revised (FPS-R)
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.
Time frame: Morning and evening on day 1 after surgery
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