Status:
COMPLETED
CARINAE for Stress Relief in Perioperative Care
Lead Sponsor:
Adhera Health, Inc.
Collaborating Sponsors:
Maastricht University Medical Center
Hospital Sant Joan de Deu
Conditions:
Psychological Stress
Cardiopulmonary Bypass Surgery
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure. Pr...
Detailed Description
Patients will be randomly assigned to intervention group or the control group. Intervention group will be exposed to the use of SaMD CARINAE for 2 months approximately. The intervention trial will inc...
Eligibility Criteria
Inclusion
- Patients planned for one of the selected surgery types:
- Cardiopulmonary bypass (CPB) surgery (Maastricht UMC+)
- Coronary artery bypass surgery (Maastricht UMC+)
- Cardiac valve replacement (SAS, Maastricht UMC+)
- Prostate, kidney, and bladder cancer surgery (INRCA)
- Hip and knee replacement (HSJD; Parc Tauli)
- Maxillofacial surgery (HSJD)
- Orthognathic surgery (HSJD)
- Scoliosis (HSJD)
- Signed informed consent (by patient or legal guardian in paediatric cases).
- Patients ≥ 18 years old, except for paediatric Hospital San Joan de Deu (HSJD) ≥ 8 years old.
- Patient owns a smartphone with Android version 4.4 or above.
- Patient (or legal guardian/caregiver in paediatric cases) is able to demonstrate basic digital literacy (e.g. knows how to communicate through instant messaging apps or similar).
Exclusion
- Dementia.
- Pregnant women.
- Inability to understand the local language.
- Allergic to dedicated wearable material (stainless steel and silicone).
- Currently enrolled in a different clinical trial.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05184725
Start Date
January 10 2022
End Date
May 31 2022
Last Update
August 1 2022
Active Locations (5)
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1
Istituto di Ricovero e Cura per Anziani
Ancona, Italy
2
Maastricht University Medical Center
Maastricht, Netherlands
3
Hospital Reina Sofía
Córdoba, Andalusia, Spain, 14004
4
Hospital San Joan de Deu
Esplugues de Llobregat, Catalonia, Spain, 08950