TONSILLECTOMYTONAPPNCT05460689
Effectiveness of a mHealth Application as a Family Supportive Tool in Pediatric Otolaryngology Perioperative Process
A study testing M-HEALTH APP in people with TONSILLECTOMY, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- TONSILLECTOMY
- What is being tested?
- M-HEALTH APP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Raffaella Dobrina, RN, BSN, MSN, 0039-3207222264, raffaella.dobrina@burlo.trieste.it
About this study
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
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
- Being tested
- M-HEALTH APP, Standard Care
- Keywords
- MHealth, Tonsillectomy, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-HEALTH APPOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Application | Experimental | mHealth App provided to caregivers of children undergoing tonsillectomy and/or adenoidectomy Receives: Other: M-HEALTH APP |
| standard support | Sham comparator | Information provided by nurses and physician orally or through printed booklets. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes before heading to the operating theatre
Secondary outcomes (6)
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start16 Dec 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TONSILLECTOMYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Cassone, RN, BSN MES, Study chair, Institute for Maternal and Child Health IRCCS Burlo GarofoloRaffaella Dobrina, RN, BSN MES, Principal investigator, Institute for Maternal and Child Health IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460689
- Sponsor's protocol ID
- 03/2022
- Acronym
- TONAPP
- Status last verified
- Jun 2024
- First submitted
- 11 Jul 2022
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dobrina R, De Vita C, Brunelli L, Galvani G, Dal Cin M, Giangreco M, Ciampechini M, Schreiber S, Ferrari G, Di Rocco P, Zaccariotto S, Saija ML, Del Giorno I, Zanchiello S, Starec A, Cassone A. mHealth-Supported Perioperative Care for Family Caregivers of Children Undergoing Tonsillectomy and/or Adenoidectomy (TONAPP): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Sep 1;14:e93989. doi: 10.2196/93989.
PubMed 42678982Dobrina 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.
PubMed 37231477
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05460689
- Acronym / sponsor ID
- TONAPP / 03/2022
- Conditions
- TONSILLECTOMY
- Keywords
- MHealth, Tonsillectomy, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone Application | Experimental | Other: M-HEALTH APPmHealth App provided to caregivers of children undergoing tonsillectomy and/or adenoidectomy |
| standard support | Sham comparator | Other: Standard CareInformation provided by nurses and physician orally or through printed booklets. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-HEALTH APPThe 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. | Other | Smartphone Application |
| Standard CareThe 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. | Other | standard support |
Primary outcome
Between groups difference in preoperative primary child caregiver state anxiety (T2)
Time frame: 5 minutes before heading to the operating theatre
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.
6 secondary outcomes
Between groups difference in state anxiety assessment at post-operative follow up (T3)
Time frame: 7 days after surgery
Between groups difference in state anxiety from enrollment and preoperative evaluations (T0 vs T2)
Time frame: 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)
Time frame: 5 minutes after enrolment / 7 days after surgery
Between groups difference in preoperative children distress (T2)
Time frame: 5 minutes before heading to the operating theatre
Between groups difference in parents' preparation for hospitalization and surgery (T1)
Time frame: 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
Time frame: 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 42678982Dobrina R, De Vita C, Brunelli L, Galvani G, Dal Cin M, Giangreco M, Ciampechini M, Schreiber S, Ferrari G, Di Rocco P, Zaccariotto S, Saija ML, Del Giorno I, Zanchiello S, Starec A, Cassone A. mHealth-Supported Perioperative Care for Family Caregivers of Children Undergoing Tonsillectomy and/or Adenoidectomy (TONAPP): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Sep 1;14:e93989. doi: 10.2196/93989.
- Derived from this study: PubMed 37231477Dobrina 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Cassone, RN, BSN MES study chair
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Raffaella Dobrina, RN, BSN MES principal investigator
Institute for Maternal and Child Health IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-HEALTH APP in people with TONSILLECTOMY, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaella Dobrina, RN, BSN MES (0039-3207222264, raffaella.dobrina@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between groups difference in preoperative primary child caregiver state anxiety (T2) (time frame: 5 minutes before heading to the operating theatre). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460689, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.