A Mobile Application for Child-focused Perioperative Education

Preoperative Anxiety Clinical Trial

Official title: A Mobile Application for Child-focused Perioperative Education: A Randomized Controlled Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Preoperative Anxiety

• NCT number: NCT06054282
• Study type: Interventional
• Source: Children's Healthcare of Atlanta
• Contact: Hari Vendantam
• Phone: 404-785-0141
• Email: hari.vendantam@choa.org
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Completion date: June 2024