Determining Change In Blood Pressure Due to Environment and Loudness

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Level of noise and environment (public vs private) while taking blood pressure measurement

• Registration Number: NCT05394376
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2022-08-09
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
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	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
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	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
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	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
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	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
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	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
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	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference in blood pressure measurement based on blood pressure level	Time of reading up to 90 minutes	To determine the difference in blood pressure measurements based on blood pressure level (SBP ≥130 mmHg vs. SBP \<130 mmHg)
Difference in blood pressure measurement based on age	Time of measurement up to 90 minutes	To determine the blood pressure difference based on age (≥ 60 years vs. \<60 years).
Difference in blood pressure measurement based on regular healthcare visits	Time of measurement up to 90 minutes	To determine the blood pressure difference based on regular healthcare visits (\>1 year vs. ≤ 1 year)

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States