Back to resultsHeart Rate Variability and Anxiety During Urinary Bladder Catheterization
Primary Purpose
Spinal Cord Injuries, Urinary Bladder, Neurogenic, Anxiety State
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-catheterization
Catheterization performed by urology nurse, participant blinded to time of procedure
Catheterization performed by urology nurse, participant aware of time of procedure
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring Intermittent Catheterization
Eligibility Criteria
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
Sites / Locations
- Blusson Spinal Cord Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Individuals with motor-complete SCI
Individuals with motor-incomplete SCI
Arm Description
Individuals with motor sensory complete injury (AIS A/B)
Individuals with motor sensory incomplete injury (AIS C/D)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Change in heart rate variability (HRV) during self-catheterization
HRV will be calculated from continuous ECG recording
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
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
Full Information
NCT ID
NCT05380661
First Posted
May 5, 2022
Last Updated
December 15, 2022
Sponsor
University of British Columbia
Collaborators
ConvaTec Inc., Vancouver Coastal Health, International Collaboration on Repair Discoveries
1. Study Identification
Unique Protocol Identification Number
NCT05380661
Brief Title
Heart Rate Variability and Anxiety During Urinary Bladder Catheterization
Official Title
Heart Rate Variability During Urinary Bladder Catheterization in Individuals With Spinal Cord Injury: Anxiety Versus Sensory Discomfort
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
ConvaTec Inc., Vancouver Coastal Health, International Collaboration on Repair Discoveries
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Urinary Bladder, Neurogenic, Anxiety State, Catheter Complications, Autonomic Dysreflexia
Keywords
Intermittent Catheterization
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Masking Description
Participants blinded to order of catheterization procedures conducted by the urology nurse.
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individuals with motor-complete SCI
Arm Type
Experimental
Arm Description
Individuals with motor sensory complete injury (AIS A/B)
Arm Title
Individuals with motor-incomplete SCI
Arm Type
Experimental
Arm Description
Individuals with motor sensory incomplete injury (AIS C/D)
Intervention Type
Procedure
Intervention Name(s)
Self-catheterization
Intervention Description
Participants will perform self-catheterization, following the same routine for intermittent catheterization at home
Intervention Type
Procedure
Intervention Name(s)
Catheterization performed by urology nurse, participant blinded to time of procedure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Catheterization performed by urology nurse, participant aware of time of procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure (BP) during self-catheterization
Description
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
Title
Heart rate (HR) during self-catheterization
Description
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
Title
BP during catheterization performed by urology nurse, participant blinded to time of procedure
Description
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
Title
HR during catheterization performed by urology nurse, participant blinded to time of procedure
Description
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
Title
BP during catheterization performed by urology nurse, participant aware of time of procedure
Description
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.
Time Frame
During catheterization performed by urology nurse, participant aware of time of procedure
Title
HR during catheterization performed by urology nurse, participant aware of time of procedure
Description
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.
Time Frame
During catheterization performed by urology nurse, participant aware of time of procedure
Title
Change in state anxiety in the context of self-catheterization (STAIS-5)
Description
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.
Time Frame
5 minutes before and 5 minutes after self-catheterization
Title
Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (STAIS-5)
Description
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.
Time Frame
5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure
Title
Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)
Description
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.
Time Frame
5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
Secondary Outcome Measure Information:
Title
Baseline trait anxiety
Description
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
Title
Change in state anxiety in the context of self-catheterization (GA-VAS)
Description
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
Title
Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (GA-VAS)
Description
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
Title
Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (GA-VAS)
Description
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
Title
Change in heart rate variability (HRV) during self-catheterization
Description
HRV will be calculated from continuous ECG recording
Time Frame
During self-catheterization
Title
Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure
Description
HRV will be calculated from continuous ECG recording
Time Frame
During catheterization performed by urology nurse, participant blinded to time of procedure
Title
Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant aware of time of procedure
Description
HRV will be calculated from continuous ECG recording
Time Frame
During catheterization performed by urology nurse, participant aware of time of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Phan, BSc
Phone
(604)675-8856
Email
jennifer.phan@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Krassioukov, MD,PhD,FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blusson Spinal Cord Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Heart Rate Variability and Anxiety During Urinary Bladder Catheterization
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