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

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

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.

Study Overview

• Status: Recruiting
• Conditions: TONSILLECTOMY
• Intervention / Treatment: Other: M-HEALTH APP; Other: Standard Care

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raffaella Dobrina, RN, BSN MES; Phone Number: 0039-3207222264; Email: raffaella.dobrina@burlo.trieste.it
• Study Contact Backup: Name: Andrea Cassone, RN, BSN MES; Phone Number: 3669284410; Email: andrea.cassone@burlo.trieste.it

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Recruiting
    • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
    • Contact: Raffaella Dobrina, RN, BSN, MSN; Phone Number: 0039-3207222264; Email: raffaella.dobrina@burlo.trieste.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone Application; mHealth App provided to caregivers of children undergoing tonsillectomy and/or adenoidectomy	Other: M-HEALTH APP; The intervention group will have in use a mHealth App for education and support of caregivers of children undergoing tonsillectomy and/or adenoidectomy in the perioperative process. An out-patient nurse will be in charge of instructing intervention group participants to mHealth App use and content options. The mHealth App will be available for intervention group families from the day of pre-admission visits to the 7th day post surgery or follow up visit.
Sham Comparator: standard support; Information provided by nurses and physician orally or through printed booklets.	Other: Standard Care; The control group will receive information and education provided by nurses and physician in the preoperative visits and during hospitalization. Information and education will be provided orally or through printed booklets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between groups difference in preoperative primary child caregiver state anxiety (T2)	Differences between intervention and control groups in preoperative primary child caregiver state anxiety, measured through the State-Trait Anxiety Inventory form Y questionnaire (T2). The questionnaire consists of two self-report scales for measuring state anxiety and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how the respondent feels "now, at this moment," on a 4 items Likert scale, from "not at all" to "very much"; the T-Anxiety scale (STAI Form Y-2) consists of twenty statements that evaluate how the respondent feels "generally" on a 4-point Likert scale from "almost never" to "almost always". Total scores range from 20 to 80 points with lower scores indicate higher trait and state anxiety.	5 minutes before heading to the operating theatre

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between groups difference in state anxiety assessment at post-operative follow up (T3)	Differences between intervention and control groups in post-operative primary child caregiver state anxiety, measured through the State-Trait Anxiety Inventory form Y questionnaire (T3). The questionnaire consists of two self-report scales for measuring state anxiety and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how the respondent feels "now, at this moment," on a 4 items Likert scale, from "not at all" to "very much"; the T-Anxiety scale (STAI Form Y-2) consists of twenty statements that evaluate how the respondent feels "generally" on a 4-point Likert scale from "almost never" to "almost always". Total scores range from 20 to 80 points with lower scores indicate higher trait and state anxiety.caregiver state anxiety will be measured through the State-Trait Anxiety Inventory form Y questionnaire in the surgical department, before heading to the operating theatre on the day of surgery (T1).	7 days after surgery
Between groups difference in state anxiety from enrollment and preoperative evaluations (T0 vs T2)	Differences between intervention and control groups primary child caregiver state anxiety from enrollment and preoperative evaluations, measured through the State-Trait Anxiety Inventory form Y questionnaire. The questionnaire consists of two self-report	5 minutes after enrolment / 5 minutes before heading to the operating theatre
Between groups difference in state anxiety from enrollment and post-operative follow up evaluations (T0 vs T3)	Differences between intervention and control groups primary child caregiver state anxiety from enrollment and post-operative follow up evaluations, measured through the State-Trait Anxiety Inventory form Y questionnaire. The questionnaire consists of two self-report scales for measuring state anxiety and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how the respondent feels "now, at this moment," on a 4 items Likert scale, from "not at all" to "very much"; the T-Anxiety scale (STAI Form Y-2) consists of twenty statements that evaluate how the respondent feels "generally" on a 4-point Likert scale from "almost never" to "almost always". Total scores range from 20 to 80 points with lower scores indicate higher trait and state anxiety.	5 minutes after enrolment / 7 days after surgery
Between groups difference in preoperative children distress (T2)	Difference between the intervention and control group in children distress assessed by surgery nurses in the surgical ward through the modified Yale Preoperative Anxiety Scale (mYPAS). The mYPAS consists of 27 items exploring five domains such as activity, emotional expressivity, state of arousal, vocalisation and use of caregivers. Scores range from 23.33 to 100, with higher scores indicating higher levels of anxiety.	5 minutes before heading to the operating theatre
Between groups difference in parents' preparation for hospitalization and surgery (T1)	The difference between the intervention and control group in parents' preparation for hospitalization and surgery evaluated by nurses through documents missing at hospital admission for surgery (number of documents missing) and surgery preparation items missing such as total body hygiene; nail polish removal and fasting (number of preparations items missing)	Within 30 minutes after the admission in the surgery ward
Between groups difference in the social and health impact of the introduction of an mHealth App	The differences between the intervention and control group in the social and health impact of the introduction of an mHealth App, measured through an ad hoc questionnaire on the day of follow up visit	7 days after surgery

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Andrea Cassone, RN, BSN MES, Institute for Maternal and Child Health IRCCS Burlo Garofolo; Principal Investigator: Raffaella Dobrina, RN, BSN MES, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Education; Tonsillectomy; MHealth
• Other Study ID Numbers: 03/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No