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)
Abstract Background Otorhinolaryngology (ORL) surgery is common in children, but hospitalisation, surgery, and home care after discharge are stressful experiences for young patients and their family caregivers. Findings from literature highlight a lack of time in hospitals to support ORL surgery chi...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07376-z |
| _version_ | 1797817791794905088 |
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| author | Raffaella Dobrina Andrea Cassone Margherita Dal Cin Luca Ronfani Manuela Giangreco Silvana Schreiber Sara Zanchiello Anja Starec Laura Brunelli Liza Vecchi Brumatti Livia Bicego |
| author_facet | Raffaella Dobrina Andrea Cassone Margherita Dal Cin Luca Ronfani Manuela Giangreco Silvana Schreiber Sara Zanchiello Anja Starec Laura Brunelli Liza Vecchi Brumatti Livia Bicego |
| author_sort | Raffaella Dobrina |
| collection | DOAJ |
| description | Abstract Background Otorhinolaryngology (ORL) surgery is common in children, but hospitalisation, surgery, and home care after discharge are stressful experiences for young patients and their family caregivers. Findings from literature highlight a lack of time in hospitals to support ORL surgery children and their caregivers through the perioperative process, along with the risks of caregivers’ autonomous web or social media resources investigation. Therefore, this study aims to evaluate the effectiveness of a mobile health application with content to support ORL patients and their caregivers in the perioperative period to reduce caregiver anxiety and child distress compared to standard care. Methods An open-label, two-arm randomised control trial design is being adopted. The intervention consists of a mobile health application with content to support ORL patients and their caregivers during the perioperative period. One hundred eighty participants will be enrolled and randomly assigned to the experimental group using the mHealth application or the control group. The control group receives standard information and education about the ORL perioperative period from healthcare providers orally or through brochures. The primary outcome is the difference between the intervention and control groups in preoperative caregiver state anxiety. Secondary outcome measures include children’s distress before surgery and family preparation for hospitalisation. Discussion The results of this study will be critical to the implementation of a new and safe model for the management of care and education in paediatrics. This model can achieve positive organisational and health outcomes by supporting continuity of care and empowering citizens to have informed participation and satisfaction in paediatric health promotion and management. Trial registration Trial identifier: NCT05460689 registry name: ClinicalTrials.gov. Date of registration: July 15, 2022. Last update posted: February 23, 2023. |
| first_indexed | 2024-03-13T08:59:43Z |
| format | Article |
| id | doaj.art-ad8742c0921641aea0cde86435feb3bc |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-13T08:59:43Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ad8742c0921641aea0cde86435feb3bc2023-05-28T11:26:50ZengBMCTrials1745-62152023-05-0124111110.1186/s13063-023-07376-zStudy 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)Raffaella Dobrina0Andrea Cassone1Margherita Dal Cin2Luca Ronfani3Manuela Giangreco4Silvana Schreiber5Sara Zanchiello6Anja Starec7Laura Brunelli8Liza Vecchi Brumatti9Livia Bicego10Healthcare Professions Department, Institute for Maternal and Child Health IRCCS Burlo GarofoloHealthcare Professions Department, Institute for Maternal and Child Health IRCCS Burlo GarofoloDepartment of Health Prevention, Azienda Sanitaria Universitaria Giuliano IsontinaClinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health IRCCS Burlo GarofoloClinical Epidemiology and Public Health Research Unit, Institute for Maternal and Child Health IRCCS Burlo GarofoloHealthcare Professions Department, Institute for Maternal and Child Health IRCCS Burlo GarofoloArea Science ParkArea Science ParkHealthcare Professions Department, Institute for Maternal and Child Health IRCCS Burlo GarofoloScientific Direction, Institute for Maternal and Child Health IRCCS Burlo GarofoloUniversity of TriesteAbstract Background Otorhinolaryngology (ORL) surgery is common in children, but hospitalisation, surgery, and home care after discharge are stressful experiences for young patients and their family caregivers. Findings from literature highlight a lack of time in hospitals to support ORL surgery children and their caregivers through the perioperative process, along with the risks of caregivers’ autonomous web or social media resources investigation. Therefore, this study aims to evaluate the effectiveness of a mobile health application with content to support ORL patients and their caregivers in the perioperative period to reduce caregiver anxiety and child distress compared to standard care. Methods An open-label, two-arm randomised control trial design is being adopted. The intervention consists of a mobile health application with content to support ORL patients and their caregivers during the perioperative period. One hundred eighty participants will be enrolled and randomly assigned to the experimental group using the mHealth application or the control group. The control group receives standard information and education about the ORL perioperative period from healthcare providers orally or through brochures. The primary outcome is the difference between the intervention and control groups in preoperative caregiver state anxiety. Secondary outcome measures include children’s distress before surgery and family preparation for hospitalisation. Discussion The results of this study will be critical to the implementation of a new and safe model for the management of care and education in paediatrics. This model can achieve positive organisational and health outcomes by supporting continuity of care and empowering citizens to have informed participation and satisfaction in paediatric health promotion and management. Trial registration Trial identifier: NCT05460689 registry name: ClinicalTrials.gov. Date of registration: July 15, 2022. Last update posted: February 23, 2023.https://doi.org/10.1186/s13063-023-07376-zmHealthTonsillectomyEducation |
| spellingShingle | Raffaella Dobrina Andrea Cassone Margherita Dal Cin Luca Ronfani Manuela Giangreco Silvana Schreiber Sara Zanchiello Anja Starec Laura Brunelli Liza Vecchi Brumatti Livia Bicego 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 mHealth Tonsillectomy Education |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | mHealth Tonsillectomy Education |
| url | https://doi.org/10.1186/s13063-023-07376-z |
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