Determining Change In Blood Pressure Due to Environment and Loudness
NCT ID: NCT05394376
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2022-08-09
2023-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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Inside private quiet1, Inside public loud, Inside public quiet, Inside private quiet2
The order of noise/environment for participants randomized to this arm will be:
Inside private quiet1, Inside public loud, Inside public quiet, Inside private quiet2
Level of noise and environment (public vs private) while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.
Inside public loud, inside private quiet1, Inside public quiet, Inside private quiet2
The order of noise/environment for participants randomized to this arm will be:
Inside public loud, inside private quiet1, Inside public quiet, Inside private quiet2
Level of noise and environment (public vs private) while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.
Inside public loud, inside public quiet, inside private quiet1, inside private quiet 2
The order of noise/environment for participants randomized to this arm will be:
Inside public loud, inside public quiet, inside private quiet1, inside private quiet 2
Level of noise and environment (public vs private) while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.
Inside public quiet, inside public loud, inside private quiet1, inside private quiet2
The order of noise/environment for participants randomized to this arm will be:
Inside public quiet, inside public loud, inside private quiet1, inside private quiet2
Level of noise and environment (public vs private) while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.
Inside public quiet, inside private quiet1, inside public loud, inside private quiet2
The order of noise/environment for participants randomized to this arm will be:
Inside public quiet, inside private quiet1, inside public loud, inside private quiet2
Level of noise and environment (public vs private) while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.
Inside private quiet1, Inside public quiet, Inside public loud, inside private quiet2
The order of noise/environment for participants randomized to this arm will be:
Inside private quiet1, Inside public quiet, Inside public loud, inside private quiet2
Level of noise and environment (public vs private) while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.
Interventions
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Level of noise and environment (public vs private) while taking blood pressure measurement
Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the level of noise in their environment changes and whether they are in a public or private setting prior to each set of measurements.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Vital Strategies
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Tammy Brady, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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References
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Ishigami J, Liu H, Zhao D, Sabit A, Pathiravasan CH, Charleston J, Miller ER 3rd, Matsushita K, Appel LJ, Brady TM. Effects of Noise and Public Setting on Blood Pressure Readings : A Randomized Crossover Trial. Ann Intern Med. 2025 Feb;178(2):149-156. doi: 10.7326/ANNALS-24-00873. Epub 2025 Jan 28.
Other Identifiers
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IRB00322730
Identifier Type: -
Identifier Source: org_study_id
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