A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study

Preventing pre-surgical stress can help patients achieve positive outcomes on
health and wellbeing. However, very few patients receive adequate stress relief
support prior to a surgical procedure. Provision of education and information
about the surgery can be a crucial component of the preoperative experience and
is inversely related to levels of preoperative anxiety. However, resource
constraints make face-to-face education sessions untenable, in view of cost
considerations and time investment by trained health personnel. Interventions
based on ICT, geared towards increasing familiarity with surgical procedures
and hospital environments have been shown to help patients feel informed about
possible benefits and risks of available treatment options. Virtual Reality
(VR) can offer patients an immersion experience in the perioperative
environment. VR interventions can be helpful in empowering patients and
enhancing a more positive experience. However, available applications focus
only on providing informative content, neglecting the importance of patient
empowerment with a more robust educational curriculum.

Objectives:
Main objective: A personalized intervention of patients* stress and anxiety
based on the combined use of standard measures (e.g. questionnaires) and
advanced tools (smart watch sensors, mHealth app and VR) through a radical
Artificial Intelligence-assisted approach to the empowerment of the patient's
psychological adaptation to a major life event such as surgery.
Secondary objectives: This study will also analyse the impact that CARINAE may
have on the following clinical outcomes in patients undergoing major surgeries:
• Self-reported stress levels along the patient journey.
• Self-reported pain levels along the patient journey.
• Health-Related Quality of Life (HRQoL).
• Emotional status.
• Mental wellbeing.
• Self-efficacy.
• Activation status: patient knowledge, skill, and confidence for
self-management.
• Medication use
• Total length of hospital stay and length of postoperative stay
• Postoperative complications, re-operation and mortality.

Besides, the CARINAE solution will also be assessed by healthcare
professionals, and patients and caregivers allocated to the intervention group,
in terms of usability, subjective satisfaction, and overall experience.

This is a prospective mixed-methods (qualitative-quantitative) multi-centric
randomized controlled trial with two groups: control group (N>=30; 6 per
clinical site) and intervention group (N>=30; 6 per clinical site). The minimum
total number of participants has been fixed in 60 subjects (30= intervention
group and 30=control group).
The maximum total participants* number has been established in 250 subjects
(125=intervention group; 25 per clinical site and 125= control group; 25 per
clinical site).

Patients randomly assigned to intervention group will be exposed to the use of
CARINAE for 4 months approximately, a patient-centred digital health support
program. This program delivers the following non-medicinal interventions to the
patients:
• Personalised patient-centred health education program to improve patient*s
disease and recovery self-management skills.
• Artificial Intelligence-based behaviour change program to promote healthier
lifestyle habits.
• Personalised mental well-being support program to improve patient*s ability
to cope with emotional disturbances such as stress and anxiety.
• A collaborative digital support platform to enable information exchange
between patients, caregivers, and healthcare professionals.
This program is delivered to patients and caregivers as an mHealth application
(smartphone app) and an immersive environment with a VR device. Healthcare
professionals will be able to access the collaborative digital support platform
through a web application.

Main study parameters/endpoints:
For assessing the main objective of the study, a personalized stress and
anxiety intervention based on technologies and artificial intelligence will be
performed to patients and caregivers belonging to intervention group from the
enrolment to the follow up at 14 days after the operation. The objective of
this personalized intervention will be to gather quantitative information to
better understand individualized experiences of patients undergoing major
surgeries and also experiences of their caregivers.
For assessing the secondary objectives, the following metrics will be used:
• Patients* and caregivers* self-reported stress will be measured by a Visual
Analogue Scale (VAS) for stress measurement at enrolment (baseline), at
admission for surgery, at hospital discharge, and 2 weeks after the surgery.
• Patients* self-reported pain will be measured by a Visual Analogue Scale
(VAS) for pain measurement at enrolment (baseline), at admission for surgery,
at hospital discharge, and 2 weeks after the surgery.
• Patients* health-related quality of life (HRQoL) will be measured by the
evolution of the EQ-5D-3L questionnaire at enrolment, admission for surgery and
at clinical discharge.
• Patients* emotional status will be measured at enrolment (baseline), at
admission for surgery, at hospital discharge, and 2 weeks after the surgery.
• Patients* and caregivers* mental wellbeing will be measured at enrolment and
2 weeks after the surgery by means of the SWEMWBS questionnaire.
• Patients* and caregivers* self-efficacy will be measured at enrolment and 2
weeks after the surgery by means of the GSE-SF questionnaire.
• Patients* activation status will be measured by means of the Patient
Activation Measure short form (PAM-13) self-reported questionnaire at
enrolment, admission for surgery and 2 weeks after the surgery.
• Data on patients* medication use will be gathered at enrolment and 2 weeks
after surgery by pulling this information from the patient*s Electronic Health
Record (EHR).
• Patients* length of hospital stay will be measured in natural days from
admission to surgery to hospital discharge.
• Patients* length of postoperative stay will be measured in natural days from
surgery day to hospital discharge.
• Data on patients* health outcomes (post-operative complications,
re-operations and mortality) will be measured 2 weeks after the surgery by
pulling this information from the patient*s EHR.
Usability will be checked per phase: pre-hospital, hospital stay, and
post-hospital. For those participants allocated to the intervention group and
healthcare professionals involved in the care management of these participants,
the following metrics will be used:
• Subjective overall patient satisfaction: If the patient likes using the
system as scale 1-10
• Evaluation of patient satisfaction with the solution:
o Ability to be carried by the patient, to be light and non-intrusive.
o Ease of learning: how fast a patient who has never used the solution can
accomplish basic tasks, even for patients with limited digital skills.
o Memorability: after using the solution, if the patient can remember enough to
use it effectively in the future.
• Evaluation of health care professionals' experience
• Net Promoter Score (NPS) will be used to measure customer experience and
provides the core measurement for customer experience management programs.
• Reliability (only intervention group) will be measured via:
o Ability to have the potential to accommodate lack of connectivity.
o Ability to transfer data into the Health Information System (if applicable).
o Ability to avoid single-point-of-failure.

The burden associated to this study is minimal, as all study visits have been
scheduled to coincide with routine care visits. During these study visits,
participants will be asked to complete a set of questionnaires that will take
as much as 30 minutes to complete. For participants allocated to intervention
group, they will receive an mHealth-based behavioural intervention delivered
through a mobile app installed in their own mobile and a VR headset that
participants can use at their convenience. This study expects to recruit minors
as participants as one of the surgical cases addressed (scoliosis surgery) is
usually delivered to the paediatric population. The behavioural intervention
will be delivered according to both the participant profile and already
validated contents and recommendations for stress management in perioperative
care and, therefore, there is no risk associated to this intervention. CARINAE
does not have any severe side/adverse effect associated to its use. However, on
some occasions (occurs in less than 1 in 10 people), when using the virtual
reality headset for the first time participants may experience dizziness,
headache, and/or motion sickness.