DECIBEL(S): Determining Change In Blood Pressure Due to Environment and Loudness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Difference between first systolic BP and average of 3 systolic BPs from measurements (mmHg)
Time Frame: 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 Frame: 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 Frame: 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 Outcomes
- 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)