Study protocol for a randomized controlled trial to determine the effectiveness of a mHealth application as a family supportive tool in pediatric otolaryngology perioperative process (TONAPP).

Abstract

Abstract Background While otorhinolaryngology (ORL) surgery is common in children, hospitalization, surgery, and post-discharge home management 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 in 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 contents to support ORL patients and their caregivers in the perioperative period to reduce caregivers’ anxiety and children distress compared to standard care. Methods An open two arm randomized control trial study design will be adopted. The intervention will consist of a mobile health application with contents to support ORL patients and their caregivers in the perioperative period. One hundred and eighty participants will be enrolled and randomly assigned to the experimental group that will have in use the m-health application or the control group. The control group will receive standard information and education about the ORL perioperative period by healthcare providers orally or through booklets. The primary outcome will be the difference between intervention and control group in preoperative caregiver state anxiety. Secondary outcome measures include children’s distress before surgery and family preparation for hospitalization. Discussion The results of the study will be critical for the implementation of a new and safe model for the management of care and education in paediatrics. In this model, organisational and health-related positive outcomes may be achieved by supporting continuity of care and empowering citizens for 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. Url: https://clinicaltrials.gov/ct2/show/NCT05460689?term=NCT05460689&draw=2&rank=1