Heart Rate Variability During Urinary Bladder Catheterization in Individuals With Spinal Cord Injury: Anxiety Versus Sensory Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)
研究概览
简要总结
This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants blinded to order of catheterization procedures conducted by the urology nurse.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Individuals with motor-complete SCI
Individuals with motor sensory complete injury (AIS A/B)
干预措施: Self-catheterization (Procedure)
Individuals with motor-complete SCI
Individuals with motor sensory complete injury (AIS A/B)
干预措施: Catheterization performed by urology nurse, participant blinded to time of procedure (Procedure)
Individuals with motor-complete SCI
Individuals with motor sensory complete injury (AIS A/B)
干预措施: Catheterization performed by urology nurse, participant aware of time of procedure (Procedure)
Individuals with motor-incomplete SCI
Individuals with motor sensory incomplete injury (AIS C/D)
干预措施: Self-catheterization (Procedure)
Individuals with motor-incomplete SCI
Individuals with motor sensory incomplete injury (AIS C/D)
干预措施: Catheterization performed by urology nurse, participant blinded to time of procedure (Procedure)
Individuals with motor-incomplete SCI
Individuals with motor sensory incomplete injury (AIS C/D)
干预措施: Catheterization performed by urology nurse, participant aware of time of procedure (Procedure)
结局指标
主要结局
Change in state anxiety in the context of catheterization performed by urology nurse, participant aware of time of procedure (STAIS-5)
时间窗: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant aware of time of procedure
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.
BP during catheterization performed by urology nurse, participant aware of time of procedure
时间窗: 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.
Change in state anxiety in the context of catheterization performed by urology nurse, participant blinded to time of procedure (STAIS-5)
时间窗: 5 minutes before and 5 minutes after catheterization performed by urology nurse, participant blinded to time of procedure
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.
BP during catheterization performed by urology nurse, participant blinded to time of procedure
时间窗: 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.
Blood pressure (BP) during self-catheterization
时间窗: 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
时间窗: 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.
HR during catheterization performed by urology nurse, participant blinded to time of procedure
时间窗: 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.
Change in state anxiety in the context of self-catheterization (STAIS-5)
时间窗: 5 minutes before and 5 minutes after self-catheterization
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.
HR during catheterization performed by urology nurse, participant aware of time of procedure
时间窗: 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.
次要结局
- Baseline trait anxiety(During screening)
- Change in state anxiety in the context of self-catheterization (GA-VAS)(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)(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)(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(During self-catheterization)
- Change in heart rate variability (HRV) during catheterization performed by urology nurse, participant blinded to time of procedure(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(During catheterization performed by urology nurse, participant aware of time of procedure)
研究者
Andrei Krassioukov
Principal Investigator
University of British Columbia