Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients

NCT06299423 | Recruiting

• 1 other identifier: 3677
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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

Keywords

Inflammatory Bowel Disease; Surgery; Anxiety and Depression

Outcome Measures

Primary Outcomes (1)

• Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV)

  Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reporting scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the median value of at least three Heart Rate Variability (HRV) measures collected in the preoperative period through the Howdy Senior® device.

  From 14 days to 1 day before surgery

Secondary Outcomes (6)

• Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI)

  90 days after surgery

• Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S)

  From 14 days to 1 day before surgery

• Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery

  24 hours after surgery

• 90-day postoperative complications

  90 days after surgery

• Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV)

  90 days after surgery

Study Arms (2)

Howdy Senior® device

EXPERIMENTAL

Patients will undergo standard perioperative management. Additionally, patients will perform three preoperative and twelve postoperative HOWDY Senior® assessments. The assessment consists of a nocturnal electrocardiogram (ECG) measure and a morning rest Heart Rate Variability (HRV) measure of five minutes.

Device: Howdy Senior® device

Standard perioperative management

NO INTERVENTION

Patients belonging to the historical cohort of comparison, who underwent standard perioperative management and surgical intervention between January 2021 and January 2022.

Interventions

Howdy Senior® device DEVICE

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

Howdy Senior® device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Antonino Spinelli, MD, PhD

  IRCCS Huamanitas Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, PhD

CONTACT

02 8224 7776; colorapp@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, interventional, case-series study with a historical cohort of comparison

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: November 22, 2023
• Primary Completion: June 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)