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

Hypertensive Urgency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572672
• Other study ID #: HE611586
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 14, 2020

Study information

• Verified date: September 2020
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 14, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertensive Urgency
• Respiratory Aspiration

Intervention

Other:
• Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting
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.

Locations

Country	Name	City	State
Thailand	Khon Kaen Unversity	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of systolic blood pressure	The change of systolic blood pressure level was assessed.	pre-intervention and 3 hours after the intervention
Primary	Change of diastolic blood pressure	The change of diastolic blood pressure level was assessed.	pre-intervention and 3 hours after the intervention
Primary	Change of heart rate	The change of heart rate was assessed.	pre-intervention and 3 hours after the intervention