A Mobile Application for Child-focused Perioperative Education
NCT ID: NCT06054282
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
360 participants
INTERVENTIONAL
2024-02-19
2024-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
"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.
Control
Families will receive standard care (standard educational handouts and preoperative consults).
No interventions assigned to this group
Interventions
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"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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
5 Years
13 Years
ALL
Yes
Sponsors
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Georgia Clinical & Translational Science Alliance AppHatchery
UNKNOWN
Children's Healthcare of Atlanta
OTHER
Responsible Party
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Principal Investigators
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Kara K Prickett, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Children's Healthcare of Atlanta; Emory University School of Medicine
Locations
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Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Kara K Prickett, MD, FACS
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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STUDY00001807
Identifier Type: -
Identifier Source: org_study_id
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