An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)

  • STATUS
    Recruiting
  • End date
    Nov 4, 2022
  • participants needed
    620
  • sponsor
    University of California, Irvine
Updated on 4 April 2021
anesthesia
anxiety
delirium
behavioral problems
anxiety reduction

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. Two hospitals and all parent-child dyads and healthcare providers (HCPs) 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) two-way communication between an HCP and patient, 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 2-7 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.

Cost of Care/Resource Use:

Determine if WebTIPS modifies healthcare resource use, as measured by 30-day charges adjusted for Medicaid cost-to-charge ratios.

Description

The proposed clustered 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) two-way communication between a clinician and patient. 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 to allow for patient/parent-provider two-way interaction and two-way sharing of information so health care providers learn about parents' coping styles.

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.

Details
Condition Pain, Acute Pain Service, ANXIETY NEUROSIS, Anxiety, Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Post-Surgical Pain, Generalized Anxiety Disorder (GAD - Pediatric), Pain (Pediatric), Anxiety Symptoms, Anxiety Disorders, Postoperative Behavior, ache, anxiety disorder, anxious
Treatment Web-based Tailored Intervention Preparation for Surgery
Clinical Study IdentifierNCT03730259
SponsorUniversity of California, Irvine
Last Modified on4 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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
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