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

Sponsor

Khon Kaen University (Other)

Overall Status

Completed

CT.gov ID

NCT04572672

Collaborator

(none)

112

Enrollment

Location

Arms

12.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertensive Urgency	Other: Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This was a single-blinded randomized controlled trial.This was a single-blinded randomized controlled trial.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Sep 14, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change of systolic blood pressure [pre-intervention and 3 hours after the intervention]
The change of systolic blood pressure level was assessed.
Change of diastolic blood pressure [pre-intervention and 3 hours after the intervention]
The change of diastolic blood pressure level was assessed.
Change of heart rate [pre-intervention and 3 hours after the intervention]
The change of heart rate was assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Khon Kaen Unversity	Khon Kaen		Thailand	40002

Sponsors and Collaborators

Khon Kaen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Praew Kotruchin, Assistant professor, Khon Kaen University

ClinicalTrials.gov Identifier:

NCT04572672

Other Study ID Numbers:

HE611586

First Posted:

Oct 1, 2020

Last Update Posted:

Oct 1, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Praew Kotruchin, Assistant professor, Khon Kaen University

Hypertensive crisis

Uncontrolled hypertension

Mindfulness

Slow breathing

Emergency room

Additional relevant MeSH terms:

Respiratory Aspiration

Study Results

No Results Posted as of Oct 1, 2020