A Mobile Application for Child-focused Perioperative Education

NCT06054282 | Recruiting

• 1 other identifier: STUDY00001807
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Children's Perioperative Multidimensional Anxiety Scale (CPMAS)

  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).

  Preoperative period, day of surgery

Secondary Outcomes (7)

• Children's Fear Scale (CFS)

  Preoperative period, day of surgery

• Patients' confidence and coping

  Preoperative period, day of surgery

• Face, Legs, Activity, Cry, Consolability (FLACC) scale

  Postoperative recovery, day of surgery

• State-trait Anxiety Inventory (STAI)

  Preoperative period, day of surgery

• Caregivers' satisfaction and self-efficacy

  Preoperative period, day of surgery

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: "Ready for Tonsillectomy" educational mobile application

Control

NO INTERVENTION

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

Interventions

"Ready for Tonsillectomy" educational mobile application BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead
• Georgia Clinical & Translational Science Alliance AppHatchery: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

Related Publications (6)

• Cordray H, Patel C, Prickett KK. Reducing Children's Preoperative Fear with an Educational Pop-up Book: A Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2022 Aug;167(2):366-374. doi: 10.1177/01945998211053197. Epub 2021 Oct 26.

  PMID: 34699270 BACKGROUND

• Chow CH, Van Lieshout RJ, Buckley N, Schmidt LA. Children's Perioperative Multidimensional Anxiety Scale (CPMAS): Development and validation. Psychol Assess. 2016 Sep;28(9):1101-9. doi: 10.1037/pas0000318.

  PMID: 27537004 BACKGROUND

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.

  PMID: 1393159 BACKGROUND

• Cordray H, Wright EA, Patel C, Raol N, Prickett KK. A Mobile Application for Child-Focused Tonsillectomy Education: Development and User-Testing. Laryngoscope. 2024 May;134(5):2455-2463. doi: 10.1002/lary.31198. Epub 2023 Nov 20.

  PMID: 37983833 BACKGROUND

Study Officials

• Kara K Prickett, MD, FACS

  Children's Healthcare of Atlanta; Emory University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hari Vendantam

CONTACT

404-785-0141; hari.vendantam@choa.org

Kara K Prickett, MD, FACS

CONTACT

kara.prickett@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigator enrolling patients will be blinded to group assignments when recruiting patients (until families have consented to participate).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: February 19, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)