Actively Recruiting

Phase Not Applicable
Age: 2Years - 10Years
All Genders
ID05460689

A Randomized Controlled Trial to Evaluate the Effectiveness of a mHealth Application as a Family Educational and Supportive Tool in Children Tonsillectomy and/or Adenoidectomy Perioperative Process Compared to Standard Care

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

180

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a mobile health (mHealth) application as a supportive educational tool for families of children undergoing tonsillectomy and/or adenoidectomy. These surgeries often cause distress for children and their families, with anxiety and postoperative complications such as pain, fever, vomiting, and bleeding creating challenges during recovery. The study aims to compare the effectiveness of this mHealth app with standard care in reducing caregiver anxiety and improving perioperative outcomes. The study involves two groups: one receiving access to the mHealth application, which provides educational content and support from the pre-admission visit through the seventh day after surgery or follow-up; the other group receives standard care consisting of oral and printed information provided by nurses and physicians. Nurses will instruct families in the intervention group on using the app. This randomized trial compares these two approaches to determine their impact on caregiver anxiety and preparation. Participants will be assessed at several points, including before surgery, immediately prior to the operating room, and seven days after surgery. Researchers will measure caregiver anxiety, children's distress, and preparedness for hospitalization and surgery. They will also evaluate the social and health impact of introducing the mHealth app. The total participation duration spans from pre-admission to one week after surgery, with monitoring of anxiety and other outcomes throughout.

CONDITIONS

Brief 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 are capable of oral and written communication without any impairment
  • Caregivers who guarantee 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 operation in the previous month
  • Caregivers who never used at least one smart phone application

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Preoperative Preparation

Duration - From pre-admission visit until surgery day

Participants attend pre-admission visits where caregivers receive education and support either via a mHealth app or standard care.

1 pre-admission visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Children undergo tonsillectomy and/or adenoidectomy surgery with immediate post-operative care.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 7 days after surgery

Participants have a follow-up visit 7 days after surgery to assess recovery and caregiver support effectiveness.

1 follow-up visit (in-person)

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

A

Andrea Cassone, RN, BSN MES

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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Published Research Related To This Trial

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

Raffaella Dobrina, Andrea Cassone, Margherita Dal Cin...

https://pubmed.ncbi.nlm.nih.gov/37231477