Using a mobile app to support families during children's tonsil surgery
A Randomized Controlled Trial to Evaluate the Effectiveness of a mHealth Application as a Family Educational and Supportive Tool in Children Tonsillectomy and/or Adenoidectomy Perioperative Process Compared to Standard Care
This study is testing a mobile app to see if it can help families feel less anxious and better supported during their child's tonsil surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 2 Years to 10 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste) |
| Trial ID | NCT05460689 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a mobile health application designed to support families during the perioperative process of pediatric tonsillectomy and adenoidectomy. It aims to reduce anxiety and improve outcomes by providing caregivers with essential information and resources related to the surgery and postoperative care. The intervention includes standard care alongside the use of the app, which is tailored to meet the needs of families with varying levels of health literacy. By addressing the emotional and informational needs of caregivers, the study seeks to enhance the overall experience for both children and their families during this common surgical procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are caregivers of children aged 2-10 who are scheduled for tonsillectomy and/or adenoidectomy and have access to a smartphone and internet.
Not a fit: Patients who may not benefit from this study include those with cognitive impairments or caregivers who have never used a smartphone application.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and improve recovery outcomes for children undergoing tonsillectomy and their families.
How similar studies have performed: Other studies have shown that mobile health interventions can effectively improve patient and caregiver outcomes, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caregivers of children aged 2-10 scheduled for tonsillectomy and/or adenoidectomy with or without tympanostomy tubes insertion; * Caregivers who are capable of oral and written communication without any impairment; * Caregivers who guarantee access to a smartphone and internet connection. Exclusion Criteria: * Caregivers with cognitive deficits; * Caregivers of children with cognitive impairment * Caregivers with visual impairment; * Caregivers of children affected by chronic pain; * Caregivers of children who had another surgery operation in the previous month. * Caregivers who never used at least one smart phone application
Where this trial is running
Trieste
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Raffaella Dobrina, RN, BSN MES — Institute for Maternal and Child Health IRCCS Burlo Garofolo
- Study coordinator: Raffaella Dobrina, RN, BSN MES
- Email: raffaella.dobrina@burlo.trieste.it
- Phone: 0039-3207222264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.