Recruiting

Observational Study

Sponsor:

Children's Healthcare of Atlanta

Code:

NCT06054282

Conditions

Preoperative Anxiety

Eligibility Criteria

Sex: All

Age: 5 - 13

Healthy Volunteers: Accepted

Interventions

"Ready for Tonsillectomy" educational mobile application

Study Details

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.

Conditions

Preoperative Anxiety

Study ID

NCT06054282

Start date

Feb 19, 2024

Status verified date

Feb, 2024

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 13

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

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.

no intervention: Control

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

Interventions

"Ready for Tonsillectomy" educational mobile application

The "Ready for Tonsillectomy" mobile application provides child-focused, procedure-specific education developed with feedback from patients, caregivers, and pediatric otolaryngologists. The application guides patients and their families through each aspect of the surgical experience, including reasons for tonsillectomy, how to prepare for surgery, anesthesia, and postoperative recovery. Diverse characters focus on the child's perspective in the treatment process, showing what happens at each step. Written at an early elementary reading level (available in English or Spanish), the text is integrated with graphics and animations. The application aims to promote active learning and equip patients with positive expectations and coping strategies as they approach surgery. It also prepares caregivers to navigate their child's surgery and optimize recovery. Notifications provide key information and reminders for caregivers to promote adherence and address common questions.

Primary outcome measure

  • Children's Perioperative Multidimensional Anxiety Scale (CPMAS) [ Time Frame: Preoperative period, day of surgery ]

Central Contacts and Locations

Central contacts

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Kara Prickett, MD, FACS

More Information

Sponsor

Children's Healthcare of Atlanta

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Keywords

  • patient education
  • tonsillectomy
  • pediatrics
  • otolaryngology
  • preoperative anxiety
  • perioperative care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Healthcare of Atlanta on 2024-02-22.