AnxietyWebTIPSNCT03730259
An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)
A study testing Web-based Tailored Intervention Preparation for Surgery in people with Anxiety and Pain, run by University of California, Irvine at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Anxiety, Pain, Postoperative Behavior
- What is being tested?
- Web-based Tailored Intervention Preparation for Surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,274 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Apr 2019to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children:
- Children scheduled to undergo anesthesia and outpatient surgery.
- Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study.
- Only children who are in the normal range of development will be recruited for this study
- Parents:
- Parents of children who are enrolled in the study.
Show all 9Show fewer
- Healthcare Providers:
- Anesthesia care providers in the two study hospitals
- Nurses who provide preoperative nursing care to children who are about to undergo surgery in the two study hospitals
Who cannot join
- Children:
- Patients with health status defined by ASA status IV-V
- Children who are not in the normal range of development and who are visually impaired will be excluded from this study.
- Children with visual impairment.
- Parents:
- Parents who refuse to be part of the study and whose children are not eligible for the study.
Show all 10Show fewer
- Parents who are visually impaired.
- Healthcare Providers:
- Anesthesiologists who refuse to be part of the study
- Nurses who refuse to be part of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CHOC Children's Hospital
Orange, California, 92868
Seattle Children's Hospital
Seattle, Washington, 98115-7869
About this study
Official title: An Innovative Tailored Intervention for Improving Children's Postoperative Recovery
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:
Read more
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:
- Examine the impact of WebTIPS on Post-Anesthesia care unit based postoperative clinical recovery parameters, such as pain and emergence delirium.
- 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.
- 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.
Read the detailed description
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.
- Conditions
- Anxiety, Pain, Postoperative Behavior
- Being tested
- Web-based Tailored Intervention Preparation for Surgery
- Keywords
- Pediatric, Pain, Postoperative, General Anesthesia, Anesthesia Recovery Period, Patient Satisfaction, mobile health
- Medical subject headings
- Anxiety Disorders, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Tailored Intervention Preparation for SurgeryOther
Also called WebTIPS
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).
| Study group | Role | What they receive |
|---|---|---|
| WebTIPS | Experimental | A Tailored Program for Perioperative Anxiety and Pain (WebTIPS) aims at reducing perioperative anxiety and pain in children via an internet and mobile platform with short message service (SMS). The Web-based Tailored Intervention Preparation for Surgery (WebTIPS) program is developed using the conceptual framework of the Triple Aim that evaluates the intervention within the context of clinical efficacy, improved child and parent surgical experience, and reduced resource utilization during the surgical episode. Receives: Other: Web-based Tailored Intervention Preparation for Surgery |
| Control | No intervention | Subjects in this attention control group, the Web-based Information (WebINFO) group will not be provided tailored content or access to SMS. Instead, this group will only receive basic information regarding the management of perioperative anxiety and postoperative pain via the internet and/or mobile platform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery (Holding Area, Separation, Entrance to operating room, and placement of the anesthesia mask)
Secondary outcomes (8)
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.
Measured: 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?).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Morning and evening on day 1 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start12 Apr 2019
- Primary completion5 Apr 2022
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Zeev Kain, University of California, Irvine
- Investigators
- Zeev Kain, MD, MBA, Principal investigator, UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730259
- Sponsor's protocol ID
- 20195130
- Other IDs
- 1R01HD091286-01A1
- Acronym
- WebTIPS
- Status last verified
- May 2026
- First submitted
- 15 Oct 2018
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Tailored Intervention for Improving Children's Postoperative Recovery
- ClinicalTrials.gov ID
- NCT03730259
- Acronym / sponsor ID
- WebTIPS / 20195130
- Conditions
- Anxiety, Pain, Postoperative Behavior
- Keywords
- Pediatric, Pain, Postoperative, General Anesthesia, Anesthesia Recovery Period, Patient Satisfaction, mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,274 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Examine the impact of WebTIPS on Post-Anesthesia care unit based postoperative clinical recovery parameters, such as pain and emergence delirium.
- 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.
- 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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WebTIPS | Experimental | Other: Web-based Tailored Intervention Preparation for SurgeryA Tailored Program for Perioperative Anxiety and Pain (WebTIPS) aims at reducing perioperative anxiety and pain in children via an internet and mobile platform with short message service (SMS). The Web-based Tailored Intervention Preparation for Surgery (WebTIPS) program is developed using the conceptual framework of the Triple Aim that evaluates the intervention within the context of clinical efficacy, improved child and parent surgical experience, and reduced resource utilization during the surgical episode. |
| Control | No intervention | –Subjects in this attention control group, the Web-based Information (WebINFO) group will not be provided tailored content or access to SMS. Instead, this group will only receive basic information regarding the management of perioperative anxiety and postoperative pain via the internet and/or mobile platform. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children scheduled to undergo anesthesia and outpatient surgery.
- Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study.
- Only children who are in the normal range of development will be recruited for this study
- Parents of children who are enrolled in the study.
- Anesthesia care providers in the two study hospitals
Key exclusion criteria (10 listed)
- Patients with health status defined by ASA status IV-V
- Children who are not in the normal range of development and who are visually impaired will be excluded from this study.
- Children with visual impairment.
- Parents who refuse to be part of the study and whose children are not eligible for the study.
- Parents who are visually impaired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Tailored Intervention Preparation for SurgeryAlso: WebTIPSA 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). | Other | WebTIPS |
Primary outcome
Assess Children's Domains of Behavior Indicating Anxiety [Activity, Emotional Expressivity, State of Arousal, Vocalization and Use of Parents]
Time frame: Day of surgery (Holding Area, Separation, Entrance to operating room, and placement of the anesthesia mask)
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.
8 secondary outcomes
Assess Pediatric Anesthesia Emergence Delirium [Emergence Status and Psychometric Evaluation in Children]
Time frame: Baseline (Post-Anesthesia Care Unit)
Change in Children's Pain Intensity Using the Postoperative Pain Measure (PPPM)
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
Time frame: Day 5, 7, 14 after surgery
Change in Children's Return to Normal Activity Using the Pediatric Quality of Life (PedsQL) Questionnaire
Time frame: The evening of day 5 after surgery
State-Trait Anxiety Inventory (STAI) (Parent Self-report)
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
Time frame: Day 1 after surgery
Children's Postoperative Pain Using the Faces, Legs, Arms, Cry and Consolability Pain Scale (FLACC)
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)
Time frame: Morning and evening on day 1 after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeev Kain, MD, MBA principal investigator
UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based Tailored Intervention Preparation for Surgery in people with Anxiety and Pain, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Children's Domains of Behavior Indicating Anxiety [Activity, Emotional Expressivity, State of Arousal, Vocalization and Use of Parents] (time frame: Day of surgery (Holding Area, Separation, Entrance to operating room, and placement of the anesthesia mask)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.