Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054282
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-09-19
Brief Title:
A Mobile Application for Child-focused Perioperative Education
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
A Mobile Application for Child-focused Perioperative Education A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators developed a child-friendly mobile application to support accessible interactive patientcaregiver 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 patientcaregiver 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 childs postoperative pain
Caregiver-initiated phone call volumes to the clinic within 2 weeks after surgery
Mobile application useinteractions 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 ie 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 consentassent 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
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 childs postoperative pain
Caregiver-initiated phone call volumes to the clinic within 2 weeks after surgery
Mobile application useinteractions 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 ie 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 consentassent 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None