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Effect of Pursed-Lip Breathing on Blood Pressure and Heart Rate

Primary Purpose

Hypertensive Urgency

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Urgency focused on measuring Hypertensive crisis, Uncontrolled hypertension, Mindfulness, Slow breathing, Emergency room

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-80 years old patients who diagnosed with HT urgency, who presented at the emergency room

Exclusion Criteria:

  • Patients with cardiac arrhythmias,
  • Acute heart failure
  • Acute coronary syndromes
  • Acute stroke
  • Acute respiratory failure
  • Alteration of consciousness
  • Pregnant women

Sites / Locations

  • Khon Kaen Unversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Purse lip breathing with number counting arm

Control arm

Arm Description

1) Position: The patient lies down in a semi-supine position, the bed is adjusted by 45-60 degrees, 2) Pursed-lip breathing and number counting "one and two" during inspiration, and 3) Number counting, "one, two, three, and four" during exhalation for the first 15 minutes (min) of each hour, total study time was 3 hours or until the patient was discharged from the ER.

The patients who were allocated to the control group received usual nursing care i.e. bed rest in a supine position in a quiet area. Patients were advised to limit their activity. The frequency of the vital signs monitoring and pharmacologic treatment were the same as the intervention group.

Outcomes

Primary Outcome Measures

Change of systolic blood pressure
The change of systolic blood pressure level was assessed.
Change of diastolic blood pressure
The change of diastolic blood pressure level was assessed.
Change of heart rate
The change of heart rate was assessed.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2020
Last Updated
September 25, 2020
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT04572672
Brief Title
Effect of Pursed-Lip Breathing on Blood Pressure and Heart Rate
Official Title
Effect of Pursed-Lip Breathing Combined With Number Counting on Blood Pressure and Heart Rate in Hypertensive Urgency Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
September 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypertensive urgency (HT urgency) is an alarm sign of uncontrolled hypertension. It can be aggravated by nonadherent to medication and psychosocial stress. Mindfulness is beneficial for reducing stress, while deep and slow breathing is effective for blood pressure (BP) lowering. The objective of the study was to assess the effect of pursed-lip breathing with number counting (PLB with NC) that promotes mindfulness and a deep/slow breathing pattern on BP and heart rate (HR) in the HT urgency patients.
Detailed Description
This was a single-blinded randomized controlled trial. Patients aged between 18-80 years old, diagnosed with HT urgency, who presented at the emergency room of Srinagarind hospital (a 1000-bed, tertiary-care level university hospital), Khon Kaen University between September 1st, 2019 to June 30th, 2020, were enrolled. Those with cardiac arrhythmias, acute HF, acute coronary syndromes, acute stroke, acute respiratory failure, alteration of consciousness, and pregnant women were excluded. This study was approved by the Khon Kaen University Ethical Review Board in Human Research (HE611586). All patients gave their written informed consent before the enrollment.HT urgency was defined as SBP >180 mmHg and/or DBP >110 mmHg without any signs or symptoms of target organ damages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Urgency
Keywords
Hypertensive crisis, Uncontrolled hypertension, Mindfulness, Slow breathing, Emergency room

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was a single-blinded randomized controlled trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Purse lip breathing with number counting arm
Arm Type
Active Comparator
Arm Description
1) Position: The patient lies down in a semi-supine position, the bed is adjusted by 45-60 degrees, 2) Pursed-lip breathing and number counting "one and two" during inspiration, and 3) Number counting, "one, two, three, and four" during exhalation for the first 15 minutes (min) of each hour, total study time was 3 hours or until the patient was discharged from the ER.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
The patients who were allocated to the control group received usual nursing care i.e. bed rest in a supine position in a quiet area. Patients were advised to limit their activity. The frequency of the vital signs monitoring and pharmacologic treatment were the same as the intervention group.
Intervention Type
Other
Intervention Name(s)
Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting
Intervention Description
Pursed-lip breathing and number counting "one and two" during inspiration, and then number counting, "one, two, three, and four" during exhalation. The nurse advised the patient to continue pursed-lip breathing with number counting for the first 15 minutes (min) of each hour to prevent the patient from being exhausted, total study time was 3 hours, or until the patient was discharged from the ER, or was withdrawn from the study.
Primary Outcome Measure Information:
Title
Change of systolic blood pressure
Description
The change of systolic blood pressure level was assessed.
Time Frame
pre-intervention and 3 hours after the intervention
Title
Change of diastolic blood pressure
Description
The change of diastolic blood pressure level was assessed.
Time Frame
pre-intervention and 3 hours after the intervention
Title
Change of heart rate
Description
The change of heart rate was assessed.
Time Frame
pre-intervention and 3 hours after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 years old patients who diagnosed with HT urgency, who presented at the emergency room Exclusion Criteria: Patients with cardiac arrhythmias, Acute heart failure Acute coronary syndromes Acute stroke Acute respiratory failure Alteration of consciousness Pregnant women
Facility Information:
Facility Name
Khon Kaen Unversity
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Pursed-Lip Breathing on Blood Pressure and Heart Rate

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