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

• Conditions: Stress Management; Anxiety; Stress

• Registration Number: NL-OMON49898
• Lead Sponsor: Salumedia Labs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

• Patients planned for one of the selected surgery types:
o Cardiopulmonary bypass (CPB) surgery (Maastricht UMC+)
o Coronary artery bypass surgery (Maastricht UMC+)
o Cardiac valve replacement (SAS, Maastricht UMC+)
o Prostate, kidney, and bladder cancer surgery (INRCA)
o Hip and knee replacement (HSJD; Parc Tauli)
o Maxillofacial surgery (HSJD)
o Orthognathic surgery (HSJD)
o Scoliosis (HSJD)
• Signed informed consent (by patient or legal guardian in paediatric cases).
• Patients >= 18 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 Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Dementia.
• Pregnant women.
• Categorized > ASA IV.
• Inability to understand the local language.
• Allergic to dedicated wearable material (stainless steel and silicone).
• Currently enrolled in a different clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified