Explanation for the choice of comparators

Standard care was chosen as comparator. Standard care given to caregivers in the ORL perioperative process consists of information and education provided by nurses and physicians during preoperative visits and hospitalisation about the ORL perioperative process. Standard information and education include topics such as ORL surgical and anaesthesiologic techniques that will be performed or strategies for pain control at home after surgery. Information and education is usually provided orally and through printed brochures.

Intervention description

The intervention group (group A) uses an a mHealth app for information and education to caregivers of children undergoing tonsillectomy and/or adenoidectomy with or without insertion of a tympanostomy tube in the perioperative process. Group A has the app in use from the day of enrolment to the day of follow-up visit. Group B receives standard care.

The content and functions of the mHealth app were developed in collaboration with an institute of maternal and child health and Area Science Park, both in Northeastern Italy. The methodological steps followed to develop the mHealth app were guided by the three cycles of the Information System Research Framework [17]. The mHealth app was developed using a user-centred participatory design approach that involved both caregivers of ORL surgical children (primary users) and hospital staff (secondary users) to understand their needs and expectations related to content topics and functionalities [18]. To promote an equally accessible understanding of the mHealth app content, a team of external communication experts was also consulted, and content, such as terminology, was simplified where necessary.

The information and education content provided in standard care to the control group by healthcare providers during hospital visits, either orally or in the form of brochures are similar to that provided to the intervention group through the medium of the mHealth app. Information topics included, for example, explaining of the surgical procedure chosen, the type of anaesthesia used, strategies for preparing children for hospitalisation and surgery, or how to manage pain at home after discharge. Because healthcare providers have little time available to inform the family about safe surgery and other topics due to the short hospital stay that characterises this type of surgery [8], the content in the app is expanded and caregivers have the opportunity to read it at the time that best suits them and with the time they need. In fact, all content is available to users at any time in a library section of the app. Moreover, in accordance with the principles of adult learning [19] and its application in telemedicine [20], the content of the application is adapted to the needs of the primary end-users and delivered “just in time” [20]. In particular, content is suggested to participants in the form of new content notifications that are available based on the specific perioperative period the child is in, such as the day of prehospital visits, the prehospital period, the day of hospitalisation and surgery, and the post-discharge period at home. Moreover, pop-up messages are displayed to the user as reminders of visits or documents to bring to the hospital. All the content is provided in text format and in Italian. This mHealth app has the potential to enable communication between primary and secondary end-users, but these features are not used by study participants and are not the subject of this study experiment.

The nurses from the ORL paediatric surgical department are in charge of caregivers of ORL surgical children enrolment. These nurses, who are familiar with all the content, functions and features of the mHealth app, are also responsible for instructing group A participants on (1) how to download the app to their smartphone or tablet and (2) how to use the mHealth app and what functions and content it offers. The app developers also created a three-minute presentation of the mHealth app, which is shown by the nurses on a tablet to the group A participants after enrolment. The mHealth app is available for group A from the day of the pre-surgery visit until the seventh day after surgery or follow-up, which usually totals 14 days. The iOS and Android app provided to group A complies with technical and sectoral regulations such as the GDPR and the NIS directive, meets standards such as ISO/IEC 27,001 and the CE label, and consists of the following: a web-based platform with a modular architecture for information support and dialogue with users, certified according to DM 93/42/CE in the class II A and meets the main sectoral requirements for functional and reliability. Moreover, the app platform and all related services are developed in accordance with the rules of the Three-Year Plan for Information Technology for Public Administration (2019/2021), as far as they are compatible, and in accordance to the “Cloud First” principle.

The app is available free of charge and is available to the hospital’s end-users. However, until the end of the trial, the app will only be available to group A study participants.

Criteria for discontinuing or modifying allocated interventions

In the event of a child’s fever or other issues causing a delay in surgery, the possibility to use the app and its content in the correct time frames will be adjusted to reflect the new surgery date selected.

Strategies to improve adherence to interventions

Considering the functionality of the app, for example, allowing content to be delivered “just in time” [20] and depending on the specific perioperative period and potential needs of the user, not only is caregiver education made more effective but also their interest in continuing to use the app is stimulated. In addition, pop-up notifications and reminders from the app assist group A participants in using the app and reading its content. Moreover, groups A and B participants are encouraged to attend scheduled visits where healthcare providers give ORL perioperative information and education.

Relevant concomitant care permitted or prohibited during the trial

We consider and permit that participants of group A and B may be exposed during the study to information derived from consultation of other health care experts, books, or web and social media.

Provisions for post-trial care

If this study demonstrates evidence of the effectiveness of the mHealth app, the app will be available for free download and use by caregivers of children undergoing tonsillectomy and/or adenoidectomy at this hospital, with or without the insertion of a tympanostomy tube.

Outcomes

The primary outcome of the study is the difference between the intervention and control groups in terms of caregivers’ self-reported state anxiety. It is be measured using the State-Trait Anxiety Inventory form Y questionnaire [21] in the surgical department, before the caregiver and child go into the operating theatre on the day of surgery, approximately seven days after enrolment.

Secondary outcomes are:

The difference between the intervention and control groups in caregiver preparation for hospitalisation and surgery, evaluated at arrival at the hospital using a checklist completed by the administrative nurse (e.g. number of documents missing on arrival) approximately 5 days after enrolment;

The difference between the intervention and control groups in preparing children for surgery, evaluated by ORL surgical nurses on arrival at the surgical department, approximately 5 days after enrolment;

The difference between the intervention and control groups in terms of children’s distress. It is assessed by ORL surgical nurses in the surgical department using the modified Yale Preoperative Anxiety Scale [22];

The difference between the intervention and control groups in self-reported primary caregiver anxiety as measured by the State-Trait Anxiety Inventory form Y questionnaire [21] on the day of follow-up, around the seventh day after surgery and 13 days after enrolment.

The difference between the intervention and control groups in terms of the social and health effects of the introduction of an mHealth app in a maternal and child hospital. It is evaluated on the day of follow-up, approximately 14 days after enrolment.

Participant timeline

Caregivers participate in the study from the day of enrolment to day 7 after surgery or follow-up. The assessment time points (T) for caregivers and children after enrolment and signing of the informed consent form are as follows:

(T0) after enrolment and allocation, data collection at time zero—(a) demographic data and (b) caregiver anxiety trait and state; (c) caregiver health literacy. At T0, participants in group A receive the app (intervention), while group B continue to receive standard care;

(T1) at hospital admission on the day of surgery—IRCCS administrative office (“Punto benvenuto”)—documents required for hospital admission and surgery;

(T2) upon admission to the surgical department ORL—(a) caregiver’s state anxiety level; (b) child’s preparation for surgery; (c) child distress;

(T3) at follow-up—caregiver’s state anxiety; social impact.

Participant timeline is shown schematically in Fig. 1.

Fig. 1

Timeline schedule of enrolment, interventions, and assessments

Sample size

Assuming a mean score of preoperative anxiety (main outcome of the study) of 50 for the control group, with a standard deviation (SD) of 13 [21], and a mean of 45 for the intervention group, with SD of 10 (effect size = 0.43), an alpha value of 0.05 and a beta value of 0.20, 180 subjects (90 per group) are needed to conduct the study (G*power, Wilcoxon-Mann–Whitney test, two groups).

Recruitment

Caregivers of children selected for ORL surgery and accessing the hospital are screened according to inclusion and exclusion criteria. The caregivers are offered to participate in this study. Recruitment is expected to last 8 months and will continue until the estimated sample size is reached.

Assignment of interventions: allocationSequence generation

Enrolled caregivers are randomly assigned into two groups (experimental group A and control group B) using a computerised number generation with simple randomisation and block randomisation with a block size of four to ensure a good balance of participants between the two groups.

Concealment mechanism

The allocation process is undertaken by the hospital’s Clinical Epidemiology and Public Health Research Unit to ensure random allocation and concealment. The allocation sequence is hidden from the researchers and other staff involved in the study in sealed, opaque, sequentially numbered envelopes.

Implementation

The nurse in the consultation rooms of the ORL paediatric surgery department is in charge to open the envelopes and give access to the app to group A, according to the number extracted and corresponding to the study arm.

Assignment of interventions: blindingWho will be blinded

Healthcare providers and participants could not be blinded in this study because the app in use is visible to caregivers and staff. Outcome assessors could not be blinded in this study.

Procedure for unblinding if needed

Because this study is an open-label study, no unblinding procedures are used.