Monitoring preoperative anxiety in patients with inflammatory bowel disease
Perioperative Electrocardiogram Remote Monitoring to Assess Preoperative Psychological Distress and Improve Postoperative Recovery in Inflammatory Bowel Disease Surgery: a Pilot Single-arm Prospective Study
This study is testing a device to see if it can help track anxiety levels in patients with inflammatory bowel disease before their surgery and understand how that anxiety might affect their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, MI) |
| Trial ID | NCT06299423 on ClinicalTrials.gov |
What this trial studies
This study evaluates preoperative psychological distress in patients with inflammatory bowel disease (IBD) undergoing surgery by remotely measuring physiological parameters and heart rate variability using the Howdy Senior® device. It aims to understand the relationship between preoperative anxiety and postoperative complications, as well as assess the feasibility of using this device for monitoring patients after discharge. The study focuses on patients scheduled for elective intestinal resection and seeks to provide insights into the autonomic responses linked to anxiety.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of Crohn's disease or ulcerative colitis scheduled for elective intestinal resection.
Not a fit: Patients with undetermined colitis, recurrent disease, or major depressive or anxiety disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved preoperative management and reduced postoperative complications for IBD patients.
How similar studies have performed: While the specific use of the Howdy Senior® device is novel, similar studies have shown that monitoring psychological distress can positively impact surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged more than 18 years old. * Established Crohn's disease (CD) or Ulcerative Colitis (UC) at the time of surgery indication with a proven histological diagnosis. * Patients scheduled for elective intestinal resection. Exclusion Criteria: * Diagnosis of Undetermined Colitis. * Recurrent disease. * Concomitant diagnosis of malignancy. * Established diagnosis of major depressive disorder or anxiety disorder. * Diagnosis of ventricular or supraventricular arrythmia. * Active pharmacological treatment with β-blockers or other drugs affecting the heart rate. * Known hypersensitivity to cotton or silver. * Emergent surgery. * Planned open surgery. * Any concomitant surgery unrelated to the main surgical indication. Patients undergoing perianal surgery for related perianal disease can be included in the study.
Where this trial is running
Rozzano, MI
- IRCCS Humanitas Research Hospital — Rozzano, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Antonino Spinelli, MD, PhD — IRCCS Huamanitas Research Hospital
- Study coordinator: Annalisa Maroli, PhD
- Email: colorapp@humanitas.it
- Phone: 02 8224 7776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.