Determining Change In Blood Pressure Due to Environment and Loudness (DECIBEL(S))
Status
Completed
Conditions
Hypertension
Treatments
Other: Level of noise and environment (public vs private) while taking blood pressure measurement
Details and patient eligibility
About
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.
Enrollment
108 patients
Sex
All
Ages
18 to 80 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Screening
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
108 participants in 6 patient groups
Inside private quiet1, Inside public loud, Inside public quiet, Inside private quiet2
Other group
Description:
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
Treatment:
Other: Level of noise and environment (public vs private) while taking blood pressure measurement
Inside public loud, inside private quiet1, Inside public quiet, Inside private quiet2
Other group
Description:
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
Treatment:
Other: Level of noise and environment (public vs private) while taking blood pressure measurement
Inside public loud, inside public quiet, inside private quiet1, inside private quiet 2
Other group
Description:
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
Treatment:
Other: Level of noise and environment (public vs private) while taking blood pressure measurement
Inside public quiet, inside public loud, inside private quiet1, inside private quiet2
Other group
Description:
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
Treatment:
Other: Level of noise and environment (public vs private) while taking blood pressure measurement
Inside public quiet, inside private quiet1, inside public loud, inside private quiet2
Other group
Description:
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
Treatment:
Other: Level of noise and environment (public vs private) while taking blood pressure measurement
Inside private quiet1, Inside public quiet, Inside public loud, inside private quiet2
Other group
Description:
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
Treatment:
Other: Level of noise and environment (public vs private) while taking blood pressure measurement
Trial contacts and locations
1
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Central trial contact
Tammy Brady, MD, PhD
Data sourced from clinicaltrials.gov
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