Effectiveness of a mHealth Application as a Family Supportive Tool in Pediatric Otolaryngology Perioperative Process (TONAPP)

IRCCS Burlo Garofolo

Status: Enrolling

Conditions: TONSILLECTOMY

Treatments: Other: Standard Care; Other: M-HEALTH APP

Study type: Interventional

Funder types: Other

Identifiers

NCT05460689

03/2022

Details and patient eligibility

About

Tonsillectomy and/or adenoidectomy are common surgeries in children. Authors report how distressed children and their families are by perioperative processes. Fear of the unknown can put a strain on the preoperative period, while pain and other possible complications such as fever, vomiting, restricted oral feeding or bleeding can create difficulties in postoperative home management. Parental anxiety has been found to worsen the perception of pain, perioperative discomfort and recovery of operated children. Providing children and families with preparation for hospitalisation, surgery and postoperative home management has been shown to improve perioperative outcomes. However, not all individuals can understand and benefit from the information provided by healthcare professionals: higher levels of anxiety in the perioperative process have been associated with individuals with low health literacy. Furthermore, unmet information needs may lead parents to expose themselves to health-related misinformation through autonomous investigations on the Web and common social media resources. Patient- and family-centred education and support is a complex and time-consuming care practice, while some surgeries such as tonsillectomy are characterised by short hospitalisations that limit the amount of time health professionals can devote to this programme. Health systems have been testing different types of formats, content and ways of delivering health information/education in order to meet the requirements of clients, time availability and effectiveness. MHealth apps in particular are an essential element of e-health and consist of medical information that is available via mobile phones or other wireless devices and can be used by patients or health professionals. Their use is growing and evolving into a variety of functionalities and positive outcomes related to improving the wellbeing of individuals, including diagnostics and clinical decision-making; interventions on healthy behaviours and lifestyles; patient disease management and self-care. Findings from literature highlight the need for further randomised controlled trials to confirm positive results.

Enrollment: 180 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Smartphone Application

Experimental group

Description:

mHealth App provided to caregivers of children undergoing tonsillectomy and/or adenoidectomy

Treatment:

Other: M-HEALTH APP

standard support

Sham Comparator group

Description:

Information provided by nurses and physician orally or through printed booklets.

Treatment:

Other: Standard Care