RecruitingNot ApplicableNCT05380661

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


Sponsor

University of British Columbia

Enrollment

20 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

Interventions

PROCEDURECatheterization 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.

PROCEDURESelf-catheterization

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

PROCEDURECatheterization 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(1)

Blusson Spinal Cord Centre

Vancouver, British Columbia, Canada

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NCT05380661


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