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

NCT ID: NCT05460689

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-16
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Smartphone Application

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

Group Type: EXPERIMENTAL

M-HEALTH APP

Intervention Type: 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.

standard support

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

Group Type: SHAM_COMPARATOR

Standard Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Cassone, RN, BSN MES

Role: STUDY_CHAIR

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Raffaella Dobrina, RN, BSN MES

Role: PRINCIPAL_INVESTIGATOR

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Locations

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

Trieste, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Raffaella Dobrina, RN, BSN MES

Role: CONTACT

raffaella.dobrina@burlo.trieste.it

0039-3207222264

Andrea Cassone, RN, BSN MES

Role: CONTACT

andrea.cassone@burlo.trieste.it

3669284410

Facility Contacts

Raffaella Dobrina, RN, BSN, MSN

Role: primary

raffaella.dobrina@burlo.trieste.it

0039-3207222264

References

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.

Reference Type: DERIVED

PMID: 37231477 (View on PubMed)

Other Identifiers

03/2022

Identifier Type: -

Identifier Source: org_study_id