NCT05380661

Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

Heart Rate Variability During Urinary Bladder Catheterization in Individuals With Spinal Cord Injury: Anxiety Versus Sensory Discomfort

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).

Detailed description

Given that intermittent catheterization is the recommended method of bladder management in individuals with SCI, it is crucial that the potentially negative cardiovascular and psychological responses to this procedure are examined. Individuals will undergo self-catheterization, then two standard of care catheterization procedures performed by an experienced urology nurse, while either blinded to or aware of time of catheterization. Continuous cardiovascular monitoring will be in place throughout all three procedures. Assessment of anxiety will be administered pre- and post- each procedure.

Conditions

• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Anxiety State
• Catheter Complications
• Autonomic Dysreflexia

Interventions

Type	Name	Description
PROCEDURE	Self-catheterization	Participants will perform self-catheterization, following the same routine for intermittent catheterization at home
PROCEDURE	Catheterization performed by urology nurse, participant blinded to time of procedure	Participant will undergo procedure to completely empty bladder; Participant in supine position, and resting blood pressure and heart rate will be recorded for period of 5 minutes prior to catheterization; Perineum and genital areas will be draped and they will be not aware about exact timing of catheterization Catheterization will be conducted following standard clinic procedure by experience urology nurse.
PROCEDURE	Catheterization performed by urology nurse, participant aware of time of procedure	Participant will undergo procedure to completely empty bladder; Participant in supine position, and resting BP and HR will be recorded for period of 5 minutes prior to catheterization; Perineum and genital areas will be visible to participant and they will be fully aware about exact timing of catheterization Catheterization will be conducted following standard clinic procedure by experience urology nurse.

Timeline

• Start date: 2022-07-15
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-05-19
• Last updated: 2024-04-26

Locations

1 site across 1 country: Canada