跳至主要内容
临床试验/NCT05981794
NCT05981794撤回不适用

The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
192
试验地点
2
主要终点
Hospital Anxiety and Depression Survey (HADS)

研究概览

简要总结

Patient frequently report experiencing discomfort associated with cystoscopy or urodynamic studies (UDS), and a small percentage of patients refuse these important procedures due to discomfort or fear of discomfort. Heating pads are an inexpensive and low-risk way to reduce patient discomfort during these procedures, which to our knowledge has not been investigated in the United States.

详细描述

Invasive office procedures such as cystoscopy and urodynamic studies (UDS) are commonly performed for many urologic and Urogynecologic conditions including, but not limited to, incontinence, voiding dysfunction, urinary retention, hematuria, and other lower urinary tract symptoms. Cystoscopy involves the insertion of a rigid or flexible cystoscope through the urethra and into the bladder. Urodynamic studies involve the placement of urethral and rectal catheters. Both cystoscopy and UDS involve filling the bladder with fluid, and these procedures are essential to the diagnosis and management of many of the conditions listed above.

While both procedures are office procedures that are generally well tolerated, some patients can experience significant discomfort, pain, or anxiety. Some nonpharmacologic therapies have been investigated to relieve anxiety, pain, and distress, such as music and aromatherapy. Heating treatments are also known to reduce muscle pain by increasing local blood flow and decreasing distress. The use of a heating pad has become an established complementary modality in some invasive procedures. A previous study from South Korea has shown benefit of heating pad use for anxiety, pain, and distress during cystoscopy and UDS; however to our knowledge, there are no studies evaluating the effect of heating pad use on patients in the United States, who may have inherent demographical differences compared to patients from South Korea.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Able to give informed consent
  • Able to read and write English or Spanish

排除标准

  • Refusal to participate
  • Contraindications to cystoscopy or urodynamic testing
  • Patients who receive other procedures or treatment at the time of cystoscopy, such as bladder biopsy or Botox injection
  • Patients with spinal cord injury or lack of sensation

结局指标

主要结局

Hospital Anxiety and Depression Survey (HADS)

时间窗: Pre- and Post-procedure (about 30 minutes)

Change in score on the anxiety subscale score, a total score of 0-21 is possible, with a score between 0-7= Normal, 8-10= Borderline abnormal and 11-21= abnormal

Change in Distress (VAS)

时间窗: Pre- and Post-procedure (about 30 minutes)

Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest

Heart rate

时间窗: Pre- and Post-procedure (about 30 minutes)

Change in heart rate

Anxiety visual analog scale (VAS)

时间窗: Pre- and Post-procedure (about 30 minutes)

Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest

Blood pressure measure

时间窗: Pre- and Post-procedure (about 30 minutes)

Change in blood pressure

Change in Pain (VAS)

时间窗: Pre- and Post-procedure (about 30 minutes)

Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest

次要结局

  • Time spent on procedure(Pre- to Post-procedure (about 30 minutes))
  • Wait time(Pre-procedure to beginning of procedure (about 30 minutes))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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