A Mobile Application for Child-focused Perioperative Education

Children's Healthcare of Atlanta

Status: Enrolling

Conditions: Preoperative Anxiety

Treatments: Behavioral: "Ready for Tonsillectomy" educational mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT06054282

STUDY00001807

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: "Ready for Tonsillectomy" educational mobile application

Control

No Intervention group

Description:

Families will receive standard care (standard educational handouts and preoperative consults).