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Completed

NCT Number: NCT04572672

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

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.

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Key information

Conditions

Hypertensive Urgency Cardiovascular Diseases Disease Attributes Emergencies Hypertension Hypertensive Crisis Hypoventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khon Kaen Unversity

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change of systolic blood pressure

    Time frame: pre-intervention and 3 hours after the intervention

    The change of systolic blood pressure level was assessed.

  2. Change of diastolic blood pressure

    Time frame: pre-intervention and 3 hours after the intervention

    The change of diastolic blood pressure level was assessed.

  3. Change of heart rate

    Time frame: pre-intervention and 3 hours after the intervention

    The change of heart rate was assessed.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2020
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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