Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299423
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-01
Brief Title:
Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Perioperative Electrocardiogram Remote Monitoring to Assess Preoperative Psychological Distress and Improve Postoperative Recovery in Inflammatory Bowel Disease Surgery a Pilot Single-arm Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PeRseo
Brief Summary:
Anxiety and depression are extremely common among Inflammatory Bowel Disease IBD patients undergoing surgery and may increase the risk of postoperative adverse outcomes This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patients physiological parameters and Heart Rate Variability HRV with the Howdy Senior device Comftech Srl Additionally the study will also investigate the feasibility and effectiveness of the Howdy Senior device in improving the postoperative patients monitoring
Detailed Description:
Inflammatory Bowel Disease IBD patients are at high risk of postoperative complications and delayed recovery Preoperative anxiety and low patients awareness of the disease may increase the risk of postoperative complications inducing an autonomic impairment which may in turn determine an inflammatory unbalance This correlation can be confirmed through the preoperative monitoring of the autonomic function- with wearable electrocardiogram ECG devices The Howdy Senior device ComfTech Srl allows the real-time remote ECG monitoring and the computation of stress and fatigue indexes
The Howdy Senior device may also provide a reliable tool for remotely monitoring the patients clinical parameters after discharge
This study aims to explore the pathophysiological mechanisms linking preoperative anxiety and autonomic response and assess the feasibility and effectiveness of the Howdy Senior device for the postoperative patients remote monitoring
The Howdy Senior device may also provide a reliable tool for remotely monitoring the patients clinical parameters after discharge
This study aims to explore the pathophysiological mechanisms linking preoperative anxiety and autonomic response and assess the feasibility and effectiveness of the Howdy Senior device for the postoperative patients remote monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None