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

NCT05460689 | Recruiting

• 1 other identifier: 03/2022
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

TONSILLECTOMY

Keywords

MHealth; Tonsillectomy; Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Between groups difference in state anxiety assessment at post-operative follow up (T3)

  7 days after surgery

• Between groups difference in state anxiety from enrollment and preoperative evaluations (T0 vs T2)

  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)

  5 minutes after enrolment / 7 days after surgery

• Between groups difference in preoperative children distress (T2)

  5 minutes before heading to the operating theatre

• Between groups difference in parents' preparation for hospitalization and surgery (T1)

  Within 30 minutes after the admission in the surgery ward

Study Arms (2)

Smartphone Application

EXPERIMENTAL

mHealth App provided to caregivers of children undergoing tonsillectomy and/or adenoidectomy

Other: M-HEALTH APP

standard support

SHAM COMPARATOR

Information provided by nurses and physician orally or through printed booklets.

Other: Standard Care

Interventions

M-HEALTH APP OTHER

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.

Smartphone Application

Standard Care OTHER

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.

standard support

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

RECRUITING

Related Publications (1)

• Dobrina R, Cassone A, Dal Cin M, Ronfani L, Giangreco M, Schreiber S, Zanchiello S, Starec A, Brunelli L, Brumatti LV, Bicego L. 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). Trials. 2023 May 25;24(1):355. doi: 10.1186/s13063-023-07376-z.

  PMID: 37231477 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrea Cassone, RN, BSN MES

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  STUDY CHAIR

• Raffaella Dobrina, RN, BSN MES

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaella Dobrina, RN, BSN MES

CONTACT

0039-3207222264; raffaella.dobrina@burlo.trieste.it

Andrea Cassone, RN, BSN MES

CONTACT

3669284410; andrea.cassone@burlo.trieste.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 15, 2022
• Study Start: December 16, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

IT (1)