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Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients

NCT06299423 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-08

No results posted yet for this study

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 patient's 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 patient's monitoring.

Conditions

  • Inflammatory Bowel Diseases
  • Surgery

Interventions

DEVICE

Howdy Senior® device

Standard perioperative management plus three preoperative and twelve postoperative (until 90 days after surgery) HOWDY Senior® device assessments.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Antonino Spinelli, MD, PhD · IRCCS Huamanitas Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2025-06-30
Completion
2025-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299423 on ClinicalTrials.gov