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

Not Applicable

Completed

• Conditions: Hypertensive Urgency
• Interventions: Other: Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting

• Registration Number: NCT04572672
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-06-30
• Status Verified: 2020-09
• Study Completion: 2020-09-14
• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Study First Posted: 2020-10-01
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Purse lip breathing with number counting arm	Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting	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.

Primary Outcome Measures

Name	Time	Method
Change of systolic blood pressure	pre-intervention and 3 hours after the intervention	The change of systolic blood pressure level was assessed.
Change of diastolic blood pressure	pre-intervention and 3 hours after the intervention	The change of diastolic blood pressure level was assessed.
Change of heart rate	pre-intervention and 3 hours after the intervention	The change of heart rate was assessed.

Trial Locations

Locations (1)

Khon Kaen Unversity; 🇹🇭 Khon Kaen, Thailand