A Mobile Application for Child-focused Perioperative Education

Not Applicable

Recruiting

• Conditions: Preoperative Anxiety
• Interventions: Behavioral: "Ready for Tonsillectomy" educational mobile application

• Registration Number: NCT06054282
• Lead Sponsor: Children's Healthcare of Atlanta

Brief Summary

The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. This randomized controlled trial aims to evaluate whether the intervention reduces preoperative anxiety, improves patients' confidence and positive coping, improves caregivers' satisfaction and self-efficacy, and reduces call volumes from caregivers to the clinic after surgery compared to current standard care.

Detailed Description

This is a prospective, questionnaire-based randomized controlled trial to evaluate a child-focused patient education intervention. The investigators developed a child-friendly mobile application to support accessible, interactive patient/caregiver education about pediatric tonsillectomy. Families in the intervention group will be invited to use the "Ready for Tonsillectomy" mobile application on their own mobile devices as they prepare for surgery and during recovery. The trial will compare preoperative anxiety and other patient-centered outcomes between families who use the mobile application (intervention) and families who receive current standard care materials without additional education (control). Primary and secondary endpoints include:

* Patients' preoperative anxiety (primary endpoint)

* Patient-reported confidence in knowing what to expect

* Patient-reported attitudes toward the procedure

* Patient-reported coping strategies

* Postoperative pain in the post-anesthesia care unit

* Caregivers' preoperative anxiety

* Caregivers' satisfaction with educational materials

* Caregivers' self-efficacy in managing their child's postoperative pain.

* Caregiver-initiated phone call volumes to the clinic within 2 weeks after surgery

* Mobile application use/interactions based on integrated user analytics

The target sample size is based on a power analysis using the primary outcome measure, which is validated for ages 7-13 years; the investigators will recruit a total of approximately 180 patients ages 7-13 years along with their caregivers (i.e., 180 caregivers for this cohort). A secondary cohort of patients ages 5-6 years will be enrolled simultaneously until the investigators reach the target sample size for the primary cohort (maximum 180 additional patients in the younger cohort, plus their caregivers). Participants will give informed verbal consent/assent at least 2 weeks before surgery. At this time, the family will be randomly assigned to either the intervention or control arm. Families in the intervention arm will download the mobile application on their smartphone or tablet; they will be able to access the application as frequently as desired in the weeks leading up to surgery and afterward. All participants will complete questionnaires while waiting in their private preoperative rooms on the day of surgery.

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Status Verified: 2024-02
• Study Start: 2024-02-19
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Pediatric patients ages 5-13 years (inclusive) scheduled for a tonsillectomy, along with their caregivers.

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Exclusion Criteria

• Patients/caregivers who do not speak English and/or Spanish, do not have a mobile device, or are unable to give consent and assent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	"Ready for Tonsillectomy" educational mobile application	Patients and caregivers will use the "Ready for Tonsillectomy" mobile application on their mobile devices as they prepare for and recover from surgery, in addition to standard care. Individual families will receive a phone call for enrollment/verbal informed consent at least 2 weeks before the scheduled surgery, likely around the time of the clinic visit when surgery is scheduled. Participants assigned to the intervention arm will download the mobile application at this time. They will be able to access the application as often as desired in the weeks leading up to surgery and afterward.

Primary Outcome Measures

Name	Time	Method
Children's Perioperative Multidimensional Anxiety Scale (CPMAS)	Preoperative period, day of surgery	The Children's Perioperative Multidimensional Anxiety Scale (CPMAS) is a patient-reported, 5-item visual analog scale validated for patients 7-13 years of age. The scale has demonstrated good internal consistency and test-retest reliability, and it is more feasible to implement than an observer-rated metric. Scores range from 0-500; higher scores indicate greater anxiety (worse outcomes).

Secondary Outcome Measures

Name	Time	Method
Patients' confidence and coping	Preoperative period, day of surgery	Patients will report their confidence in knowing what to expect and their attitudes toward the procedure on a Likert scale. Scores range from 1-5; higher scores indicate more positive views (better outcomes). In an open-ended text field, patients will also be asked to report any coping strategies that they are using or might use if they felt worried about the procedure. These responses will be coded according to a content analysis system based on pediatric coping literature.
State-trait Anxiety Inventory (STAI)	Preoperative period, day of surgery	Caregivers will report their own preoperative anxiety using a validated 6-item short form of the State-trait Anxiety Inventory (STAI). This is a well-established measure of state anxiety widely used in clinical research. Sum scores range from 6-24; higher scores indicate greater anxiety (worse outcomes).
User analytics	Throughout the study period (beginning with time of download)	Within the intervention group, integrated user analytics software will track participants' use of different pages of the application (Pendo.io, Inc.). The investigators will use this data to evaluate the fidelity of the intervention, correlate patient outcomes with the extent of intervention use, and inform possible revisions to improve engagement for future users.
Face, Legs, Activity, Cry, Consolability (FLACC) scale	Postoperative recovery, day of surgery	In light of potential benefits of Enhanced Recovery After Surgery protocols, the investigators will collect Face, Legs, Activity, Cry, Consolability (FLACC) scale scores as a measure of postoperative pain. Postoperative nurses standardly record this measure in the post-anesthesia care unit. Scores range from 0-10; higher scores indicate greater pain (worse outcomes).
Caregivers' satisfaction and self-efficacy	Preoperative period, day of surgery	On a Likert scale, caregivers will report their satisfaction with the educational materials they received as well as their self-efficacy in managing their child's postoperative pain. Scores range from 1-5; higher scores indicate more positive views (better outcomes).
Children's Fear Scale (CFS)	Preoperative period, day of surgery	Patients 5-6 years of age will complete the Children's Fear Scale (CFS), which is validated for this age cohort, in lieu of the CPMAS. CFS scores range from 0-4; higher scores indicate greater fear (worse outcomes).
Caregiver-initiated postoperative call volumes	Up to 2 weeks after surgery	Caregiver-initiated phone encounters within 2 weeks after surgery will be reviewed in the medical record to determine if the intervention reduced caregivers' need to call the clinic with postoperative questions.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States