Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

University of British Columbia20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

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

Interventions

Self-catheterizationPROCEDURE

Participants will perform self-catheterization, following the same routine for intermittent catheterization at home

Catheterization performed by urology nurse, participant blinded to time of procedurePROCEDURE

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.

Catheterization performed by urology nurse, participant aware of time of procedure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, 18-70 years of age * Any chronic traumatic SCI with either motor sensory complete injury (AIS A/B, N=10) or motor sensory incomplete injury (AIS B/D, N=10). * At least 1 year post injury, and at least 6 months from any spinal surgery * Hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage * Must provide informed consent and be able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator) * Willing and able to comply with clinic visit and study-related procedures Exclusion Criteria: * Signs or known current urinary tract infection, or other inflammatory conditions of bladder/urethra * Currently taking beta blockers or other medications that may affect heart rate * History of ureteral injury * History of any urinary diversion procedures, including but not limited to bladder augmentation, cystectomy, neo bladder, pouch reservoir, ileal conduit, Mitrofanoff appendicovesicostomy * For women of childbearing potential, currently pregnant * A member of the investigational team or his/her immediate family Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study

Locations (1)

Blusson Spinal Cord Centre

Vancouver, British Columbia, Canada

RECRUITING

Outcomes

Primary Outcomes

Blood pressure (BP) during self-catheterization

Systolic and diastolic BP (mmHg) will be measured continuously (beat-by-beat) via finger photoplethysmography, corrected to brachial pressure. BP will be measured 5 minutes prior to and then throughout the self-catheterization procedure.

Time frame: During self-catheterization

Heart rate (HR) during self-catheterization

HR (BPM) will be recorded continuously via one-lead electrocardiogram. HR will be measured 5 minutes prior to and then throughout the self-catheterization procedure.

Time frame: During self-catheterization

BP during catheterization performed by urology nurse, participant blinded to time of procedure

Systolic and diastolic BP (mmHg) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is blinded to time of procedure.

Time frame: During catheterization performed by urology nurse, participant blinded to time of procedure

HR during catheterization performed by urology nurse, participant blinded to time of procedure

HR (BPM) will be measured 5 minutes prior to and then throughout the standard of care catheterization performed by an experienced urology nurse, while the participant is blinded to time of procedure.

Time frame: During catheterization performed by urology nurse, participant blinded to time of procedure

BP during catheterization performed by urology nurse, participant aware of time of procedure

Time frame: During catheterization performed by urology nurse, participant aware of time of procedure

Central Contacts

Andrea Maharaj, BSc

CONTACT

(604) 675-8856 amaharaj@icord.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Baseline trait anxiety

The 7-item General Anxiety Disorder (GAD) scale will be used to measure participants' anxiety. The GAD-7 sum score will be calculated, ranging from 0 to 21, with higher score indicating more severe anxiety symptoms.

Time frame: During screening

Change in state anxiety in the context of self-catheterization (GA-VAS)

The Global Anxiety-Visual Analogue Scale (GA-VAS) will be used to measure participants' state anxiety prior to and after self-catheterization. Rating can range between 0 to 10, with higher rating on the GA-VAS indicates greater state anxiety.

Time frame: 5 minutes before and 5 minutes after self-catheterization

Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (GA-VAS)

The GA-VAS will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is blinded to time of procedure. Rating can range between 0 to 10, higher rating on the GA-VAS indicates greater state anxiety.

Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure

Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (GA-VAS)

The GA-VAS will be used to measure participants' state anxiety prior to and after catheterization procedure performed by an experienced urology nurse, while the participant is aware of time of procedure. Higher rating on the GA-VAS indicates greater state anxiety.

Time frame: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure

Change in heart rate variability (HRV) during self-catheterization

HRV will be calculated from continuous ECG recording

Time frame: During self-catheterization

Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure

HRV will be calculated from continuous ECG recording

Time frame: During catheterization performed by urology nurse, participant blinded to time of procedure

Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant aware of time of procedure

HRV will be calculated from continuous ECG recording

Time frame: During catheterization performed by urology nurse, participant aware of time of procedure