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

Effect of Pursed-Lip Breathing Combined With Number Counting on Blood Pressure and Heart Rate in Hypertensive Urgency Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypertensive Urgency
• Intervention / Treatment: Other: Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Khon Kaen Unversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Purse lip breathing with number counting arm; 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.	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.
NO_INTERVENTION: Control arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of systolic blood pressure	The change of systolic blood pressure level was assessed.	pre-intervention and 3 hours after the intervention
Change of diastolic blood pressure	The change of diastolic blood pressure level was assessed.	pre-intervention and 3 hours after the intervention
Change of heart rate	The change of heart rate was assessed.	pre-intervention and 3 hours after the intervention

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): September 14, 2020

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (ACTUAL): October 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Mindfulness; Uncontrolled hypertension; Emergency room; Hypertensive crisis; Slow breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: HE611586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No