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
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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
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
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
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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"
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...