Actively Recruiting

Phase Not Applicable
Age: 2Years - 10Years
All Genders
NCT05460689

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

Led by IRCCS Burlo Garofolo · Updated on 2024-06-13

180

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers of children aged 2-10 scheduled for tonsillectomy and/or adenoidectomy with or without tympanostomy tubes insertion
  • Caregivers who can communicate orally and in writing without impairment
  • Caregivers who have access to a smartphone and internet connection
Not Eligible

You will not qualify if you...

  • 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 in the previous month
  • Caregivers who have never used a smartphone application

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, Italy, 34137

Actively Recruiting

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Research Team

R

Raffaella Dobrina, RN, BSN MES

CONTACT

A

Andrea Cassone, RN, BSN MES

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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