Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380661
• Other study ID #: H22-00971
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of British Columbia
• Contact: Andrea Maharaj, BSc
• Phone: (604) 675-8856
• Email: amaharaj[@]icord.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Self-catheterization
Participants will perform self-catheterization, following the same routine for intermittent catheterization at home
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Blusson Spinal Cord Centre	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	ConvaTec Inc., International Collaboration on Repair Discoveries, Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During self-catheterization
Primary	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.	During self-catheterization
Primary	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.	During catheterization performed by urology nurse, participant blinded to time of procedure
Primary	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.	During catheterization performed by urology nurse, participant blinded to time of procedure
Primary	BP during catheterization performed by urology nurse, participant aware of 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 aware of time of procedure.	During catheterization performed by urology nurse, participant aware of time of procedure
Primary	HR during catheterization performed by urology nurse, participant aware of 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 aware of time of procedure.	During catheterization performed by urology nurse, participant aware of time of procedure
Primary	Change in state anxiety in the context of self-catheterization (STAIS-5)	The State-Trait Anxiety Inventory - State, 5 item version (STAIS-5) will be used to measure participants' state anxiety prior to and after self-catheterization. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety.	5 minutes before and 5 minutes after self-catheterization
Primary	Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (STAIS-5)	The STAIS-5 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. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety.	5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure
Primary	Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)	The STAIS-5 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. Sum score of the STAIS-5 will be calculated, which ranges between 5 to 20, with higher score indicating greater state anxiety.	5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Secondary	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.	During screening
Secondary	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.	5 minutes before and 5 minutes after self-catheterization
Secondary	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.	5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure
Secondary	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.	5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Secondary	Change in heart rate variability (HRV) during self-catheterization	HRV will be calculated from continuous ECG recording	During self-catheterization
Secondary	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	During catheterization performed by urology nurse, participant blinded to time of procedure
Secondary	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	During catheterization performed by urology nurse, participant aware of time of procedure