Determining Change In Blood Pressure Due to Environment and Loudness

Study Overview
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: Level of noise and environment (public vs private) while taking blood pressure measurement


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Inside private quiet1, Inside public loud, Inside public quiet, Inside private quiet2<br>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 | Other: Level of noise and environment (public vs private) while taking blood pressure measurement<br>* 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.<br>|
| Other: Inside public loud, inside private quiet1, Inside public quiet, Inside private quiet2<br>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 | Other: Level of noise and environment (public vs private) while taking blood pressure measurement<br>* 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.<br>|
| Other: Inside public loud, inside public quiet, inside private quiet1, inside private quiet 2<br>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 | Other: Level of noise and environment (public vs private) while taking blood pressure measurement<br>* 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.<br>|
| Other: Inside public quiet, inside public loud, inside private quiet1, inside private quiet2<br>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 | Other: Level of noise and environment (public vs private) while taking blood pressure measurement<br>* 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.<br>|
| Other: Inside public quiet, inside private quiet1, inside public loud, inside private quiet2<br>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 | Other: Level of noise and environment (public vs private) while taking blood pressure measurement<br>* 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.<br>|
| Other: Inside private quiet1, Inside public quiet, Inside public loud, inside private quiet2<br>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 | Other: Level of noise and environment (public vs private) while taking blood pressure measurement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg) | 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 | Time of reading up to 90 minutes | 
| Difference between first diastolic BP and average of 3 diastolic BPs from measurements (mmHg) | 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 | Time of reading up to 90 minutes | 
| Systolic and Diastolic Differences in blood pressure measurement (mmHg) | 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) | Time of reading up to 90 minutes | 

Secondary Outcome Measures

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