Determining Change In Blood Pressure Due to Environment and Loudness

NCT ID: NCT05394376

Last Updated: 2023-09-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

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

Group Type OTHER

Level of noise and environment (public vs private) while taking blood pressure measurement

Intervention Type OTHER

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

Group Type OTHER

Level of noise and environment (public vs private) while taking blood pressure measurement

Intervention Type OTHER

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

Group Type OTHER

Level of noise and environment (public vs private) while taking blood pressure measurement

Intervention Type OTHER

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

Group Type OTHER

Level of noise and environment (public vs private) while taking blood pressure measurement

Intervention Type OTHER

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

Group Type OTHER

Level of noise and environment (public vs private) while taking blood pressure measurement

Intervention Type OTHER

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

Group Type OTHER

Level of noise and environment (public vs private) while taking blood pressure measurement

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vital Strategies

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 39869911 (View on PubMed)

Other Identifiers

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IRB00322730

Identifier Type: -

Identifier Source: org_study_id

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