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临床试验/NCT05394376
NCT05394376已完成不适用

DECIBEL(S): Determining Change In Blood Pressure Due to Environment and Loudness

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg)

研究概览

简要总结

Determine the effects of environment and sound on initial and average triplicate screening blood pressure done according to clinical practice guidelines with an automated device.

Standardly obtained blood pressures obtained in a noisy, busy, public space will be higher than attended blood pressures obtained (1) in the same environment but with earplugs to minimize sound and (2) in a quiet, private space without surrounding activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years

排除标准

  • Hearing loss requiring hearing aids
  • Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, A-V shunts.
  • Being mentally impaired
  • Being pregnant
  • Arm circumference exceeding 55 cm.

结局指标

主要结局

Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg)

时间窗: Time of reading up to 90 minutes

Absolute difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg) obtained in: * Inside public loud vs. Inside private quiet1 * Inside public quiet vs. Inside private quiet1 * Inside private quiet1 vs. Inside private quiet2

Systolic and Diastolic Differences in blood pressure measurement (mmHg)

时间窗: Time of reading up to 90 minutes

Systolic and Diastolic Difference of differences between: * (Inside private quiet 1 - Inside private quiet 2) and (Inside public loud- Inside private quiet 1) * (Inside private quiet1 - Inside private quiet2) and (Inside public quiet - Inside private quiet1)

Difference between first diastolic BP and average of 3 diastolic BPs from measurements (mmHg)

时间窗: Time of reading up to 90 minutes

Absolute difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg) obtained with: * Inside public loud vs. Inside private quiet1 * Inside public quiet vs. Inside private quiet1 * Inside private quiet1 vs. Inside private quiet2

次要结局

  • Difference in blood pressure measurement based on blood pressure level(Time of reading up to 90 minutes)
  • Difference in blood pressure measurement based on age(Time of measurement up to 90 minutes)
  • Difference in blood pressure measurement based on regular healthcare visits(Time of measurement up to 90 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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