Clinical trial NCT05460689: Effectiveness of a mHealth Application as a Family Supportive Tool in Pediatric Otolaryngology Perioperative Process
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TONSILLECTOMY
Keywords: MHealth
Tonsillectomy
Education
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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

Primary outcomes:
measure: Between groups difference in preoperative primary child caregiver state anxiety (T2)
timeFrame: 5 minutes before heading to the operating theatre
Secondary outcomes:
measure: Between groups difference in state anxiety assessment at post-operative follow up (T3)
timeFrame: 7 days after surgery
measure: Between groups difference in state anxiety from enrollment and preoperative evaluations (T0 vs T2)
timeFrame: 5 minutes after enrolment / 5 minutes before heading to the operating theatre
measure: Between groups difference in state anxiety from enrollment and post-operative follow up evaluations (T0 vs T3)
timeFrame: 5 minutes after enrolment / 7 days after surgery
measure: Between groups difference in preoperative children distress (T2)
timeFrame: 5 minutes before heading to the operating theatre
measure: Between groups difference in parents' preparation for hospitalization and surgery (T1)
timeFrame: Within 30 minutes after the admission in the surgery ward
measure: Between groups difference in the social and health impact of the introduction of an mHealth App
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Andrea Cassone, RN, BSN MES
role: STUDY_CHAIR
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Raffaella Dobrina, RN, BSN MES
role: PRINCIPAL_INVESTIGATOR
References: