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

NCT04572672 | Completed

• 1 other identifier: HE611586
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Urgency

Keywords

Hypertensive crisis; Uncontrolled hypertension; Mindfulness; Slow breathing; Emergency room

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Purse lip breathing with number counting arm

ACTIVE COMPARATOR

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

Control arm

NO INTERVENTION

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.

Interventions

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

Purse lip breathing with number counting arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen Unversity

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Hypertensive Crisis; Hypoventilation; Emergencies

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: This was a single-blinded randomized controlled trial.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 1, 2020
• Study Start: September 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: September 14, 2020
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)