Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Feb 23, 2026
Date Accepted: Jul 17, 2026
Supporting family caregivers of children undergoing tonsillectomy and/or adenoidectomy in the perioperative process through an mHealth application: the TONAPP Randomized Controlled Trial results
ABSTRACT
Background:
Paediatric Ear-Nose-Throat (ENT) surgery is common but generates perioperative anxiety for caregivers and distress in children. Limited time for perioperative education and reliance on unverified online information can reduce family preparedness and increase stress. Few studies have evaluated co-designed mHealth apps to support and engage families in the perioperative ENT journey.
Objective:
To compare caregiver anxiety between an mHealth app-supported care pathway and standard supportive and educational care alone in the perioperative ENT context. Secondary objectives explored between-group differences in caregiver anxiety at follow-up, family preparation, child distress, and social-impact indicators.
Methods:
A two-arm, open-label randomized controlled trial enrolled caregivers of children undergoing ENT surgery (tonsillectomy, adenoidectomy, tympanostomy tubes insertion). Participants were randomized to app use or standard care alone. Primary outcome: caregiver state anxiety (STAI-Y1). Secondary outcomes: child distress (mYPAS), family preparation for surgery, and social impact indicators. App engagement metrics were collected.
Results:
The caregivers enrolled were 227, reaching sample size. Groups were equivalent at baseline for demographics, health literacy, and anxiety (all P>.05). No statistically significant differences were observed between groups for primary nor for secondary outcomes (all P>.05). App users (median usage: 6 days) engaged predominantly with postoperative management content. Higher baseline anxiety was linked to lower app use (ρ=-.22, P= .02), while greater use was linked to lower child distress (ρ=-.23, P=.02).
Conclusions:
Although hypotheses were not confirmed, these negative findings remain valuable. They reduce bias, guide app refinement, and show the strength of routine education, the complexity of perioperative distress for caregivers and children, and the role of information-seeking and cultural factors, including autonomous web searching and timing of app use. In the context of global understaffing, especially for nurses, the app may still support continuity of family care. Clinical Trial: NCT05460689
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