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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 10
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Institute for Maternal and Child Health - IRCCS Burlo Garofolo
RECRUITING
Trieste
Contact Information
Primary
Raffaella Dobrina, RN, BSN MES
raffaella.dobrina@burlo.trieste.it
0039-3207222264
Backup
Andrea Cassone, RN, BSN MES
andrea.cassone@burlo.trieste.it
3669284410
Time Frame
Start Date: 2022-12-16
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 180
Treatments
Experimental: Smartphone Application
mHealth App provided to caregivers of children undergoing tonsillectomy and/or adenoidectomy
Sham_comparator: standard support
Information provided by nurses and physician orally or through printed booklets.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Burlo Garofolo

This content was sourced from clinicaltrials.gov