Clinical trial NCT06054282: A Mobile Application for Child-focused Perioperative Education
Official title: A Mobile Application for Child-focused Perioperative Education: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preoperative Anxiety
Keywords: patient education
tonsillectomy
pediatrics
otolaryngology
preoperative anxiety
perioperative care
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
Collaborators: name: Georgia Clinical & Translational Science Alliance AppHatchery
First posted: 2023-09-26
Enrollment: 360
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's Perioperative Multidimensional Anxiety Scale (CPMAS)
timeFrame: Preoperative period, day of surgery
Secondary outcomes:
measure: Children's Fear Scale (CFS)
timeFrame: Preoperative period, day of surgery
measure: Patients' confidence and coping
timeFrame: Preoperative period, day of surgery
measure: Face, Legs, Activity, Cry, Consolability (FLACC) scale
timeFrame: Postoperative recovery, day of surgery
measure: State-trait Anxiety Inventory (STAI)
timeFrame: Preoperative period, day of surgery
measure: Caregivers' satisfaction and self-efficacy
timeFrame: Preoperative period, day of surgery
measure: Caregiver-initiated postoperative call volumes
timeFrame: Up to 2 weeks after surgery
measure: User analytics
timeFrame: Throughout the study period (beginning with time of download)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta; Emory University School of Medicine
name: Kara K Prickett, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.