NCT06119412

Brief Summary

This cross design study will be conducted to evaluate the combination of palpation and auscultation techniques as an alternative technique for the measurement of blood pressure. The main questions it aims to answer are:

  • Is there a statistical difference between the results of systolic blood pressure measured with the old and new technique?
  • Is there a statistical difference between the results of systolic blood pressure measured with the old and new technique? Participants' blood pressure will be measured twice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

12 days

First QC Date

October 20, 2023

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • blood pressure measurement list

    This form will record the participant's systolic and diastolic blood pressure measured with the standard technique and the alternative new technique.

    approximately 12 weeks from the start of measurements until reporting.

Secondary Outcomes (1)

  • blood pressure measurement time

    approximately 12 weeks from the start of measurements until reporting.

Study Arms (2)

group 1, starting with standard technique

OTHER

According to block randomization, the 1st researcher will first apply the standard technique (60 seconds pause between palpation and auscultation), 1 minute break will be given, and the 2nd researcher will apply the alternative new technique (no break between palpation and auscultation) on the same person.

Other: blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.

group 2, starting with alternative new technique

OTHER

According to block randomization, Investigator 1 will first apply the alternative new technique (no pause between palpation and auscultation) to the people in the second group, and a 1-minute break will be given. The 2nd researcher will apply the standard technique (60 seconds break between palpation and auscultation) on the same person.

Other: blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.

Interventions

Each participant will have their blood pressure measured with two different techniques.

group 1, starting with standard techniquegroup 2, starting with alternative new technique

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age,
  • no chronic disease,
  • not taking any medication and/or treatment that affects the cardiovascular or circulatory system,
  • volunteering to participate in the research.

You may not qualify if:

  • has a chronic disease,
  • taking medication that affects the cardiovascular or circulatory system,
  • wants to leave the study at any stage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Department of Health Sciences

Ankara, 06490, Turkey (Türkiye)

Location

Study Officials

  • Evrim Eyikara

    doctor research assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Research assistant, Principal Investigator

Study Record Dates

First Submitted

October 20, 2023

First Posted

November 7, 2023

Study Start

October 20, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations