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

NCT ID: NCT04572672

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-09-14

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.

Conditions

Hypertensive Urgency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Praew Kotruchin

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Khon Kaen Unversity

Khon Kaen, , Thailand

Countries

Thailand

Other Identifiers

HE611586

Identifier Type: -

Identifier Source: org_study_id