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Study protocol for a randomised controlled trial to determine the effectiveness of a mHealth application as a family
Raffaella Dobrina1, Andrea Cassone2, Margherita Dal Cin3
1Healthcare Professions Department, Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy. raffaella.dobrina@burlo.trieste.it.
Insights
This study evaluates a mobile health app to reduce caregiver anxiety and child distress during pediatric Otorhinolaryngology (ORL) surgery. The app aims to improve perioperative care and family preparation compared to standard methods.
Area of Science:
- Pediatric Surgery
- Digital Health Interventions
- Patient Education
Background:
- Pediatric Otorhinolaryngology (ORL) surgery involves stressful hospitalizations and perioperative periods for children and caregivers.
- Existing healthcare settings often lack sufficient time for comprehensive patient and caregiver support.
- Caregivers frequently rely on unverified online resources, increasing risks during the perioperative phase.
Purpose of the Study:
- To assess the effectiveness of a mobile health (mHealth) application in supporting pediatric ORL patients and their caregivers.
- To reduce caregiver anxiety and child distress during the perioperative period.
- To compare the mHealth intervention against standard care in managing pediatric ORL surgical patients.
Main Methods:
- An open-label, two-arm randomized controlled trial.
- 180 participants will be randomized to either an mHealth application group or a standard care control group.
- Primary outcome: preoperative caregiver state anxiety. Secondary outcomes: child distress and family preparation for hospitalization.
Main Results:
- N/A - Results pending study completion.
Conclusions:
- The study's findings are anticipated to be crucial for implementing innovative care and education models in pediatrics.
- The research aims to support continuity of care and enhance patient/caregiver satisfaction and informed participation.
- This initiative seeks to achieve positive organizational and health outcomes in pediatric care management.
Background:
Otorhinolaryngology (ORL) surgery is common in children, but hospitalisation, surgery, and home care after discharge are stressful experiences for young patients and their family caregivers. Findings from literature highlight a lack of time in hospitals to support ORL surgery children and their caregivers through the perioperative process, along with the risks of caregivers' autonomous web or social media resources investigation. Therefore, this study aims to evaluate the effectiveness of a mobile health application with content to support ORL patients and their caregivers in the perioperative period to reduce caregiver anxiety and child distress compared to standard care.
Methods:
An open-label, two-arm randomised control trial design is being adopted. The intervention consists of a mobile health application with content to support ORL patients and their caregivers during the perioperative period. One hundred eighty participants will be enrolled and randomly assigned to the experimental group using the mHealth application or the control group. The control group receives standard information and education about the ORL perioperative period from healthcare providers orally or through brochures. The primary outcome is the difference between the intervention and control groups in preoperative caregiver state anxiety. Secondary outcome measures include children's distress before surgery and family preparation for hospitalisation.
Discussion:
The results of this study will be critical to the implementation of a new and safe model for the management of care and education in paediatrics. This model can achieve positive organisational and health outcomes by supporting continuity of care and empowering citizens to have informed participation and satisfaction in paediatric health promotion and management.
Trial Registration:
Trial identifier: NCT05460689 registry name: ClinicalTrials.gov. Date of registration: July 15, 2022. Last update posted: February 23, 2023.
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