The Effect of Slow Breathing Exercise Applied to Patients on Pulse, Blood Pressure and Quality of Life

NCT ID: NCT06098222

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2024-10-01

Brief Summary

This study was designed as a randomized controlled experimental type in order to determine the effect of slow breathing exercise applied after the procedure on heart rate, blood pressure and quality of life in patients who underwent Primary Percutaneous Coronary Intervention (PCI) I after the diagnosis of ST Elevation Myocardial Infarction (STEMI).

Patients who underwent primary PCI due to STEMI in a Training and Research Hospital in Istanbul will constitute the study population. A sample will be formed with a total of 80 patients, 40 experimental and 40 control groups, selected by computer assisted simple randomization method among volunteer patients who underwent primary PCI and met the inclusion criteria.

In this study, slow breathing exercise training will be given to the experimental group by the coordinator. In their home followmup after discharge, they will be asked to do slow breathing exercises for 10 minutes twice a day for eight weeks.

Data will be collected using the "Patient Information Form", "MacNew Heart Disease Health Related Quality of Life Scale", "VAS Breath Therapy Satisfaction Evaluation Form", "Self-Monitoring Form" and "Patient Follow up Form". Patients will be seen again during the outpatient clinic examination in the fourth and eighth weeks and the effectiveness of slow breathing exercises will be evaluated with data collection forms.

Detailed Description

Cardiovascular Diseases (CVD) is still the leading cause of death in the world and in our country, despite significant advances in its diagnosis and treatment. Acute Coronary Syndromes (ACS), which are among the CVD's, occur with the deterioration of the integrity of the atherosclerotic plaque in the coronary vessels. The deadliest form of ACS is ST Elevation Myocardial Infarction (STEMI).

Primary Percutaneous Coronary Intervention (PCI) is recommended primarily in the treatment of acute myocardial infarction. In these patients, changes in vital signs resulting from diagnosis and treatment and a permanent effect on quality of life can be observed.

Slow breathing exercise is a behavioral technique in which a low breathing rate is applied. Breathing exercises reduce heart rate, blood pressure, reduce anxiety and pain while shown to improve symptoms and improve quality of life in patients with chronic obstructive pulmonary disease and asthma. This technique provides conscious deep and slow breathing and effective breathing, as well as improving conscious control over relaxation and increasing awareness.

This study was designed as a randomized controlled experimental type in order to determine the effect of slow breathing exercise applied after the procedure on heart rate, blood pressure and quality of life in patients who underwent PCI after the diagnosis of STEMI. Study data will be collected between 23 October 2023- 30 April 2024 Patients who underwent primary PCI due to STEMI in a Training and Research Hospital in Istanbul will constitute the study population. A sample will be formed with a total of 80 patients, 40 experimental and 40 control groups, selected by computer assisted simple randomization method among volunteer patients who underwent primary PCI and met the inclusion criteria.

In the study, slow breathing exercise training will be given to the experimental group by the coordinator. In their home followmup after discharge, they will be asked to do slow breathing exercises for 10 minutes twice a day for eight weeks. It will be ensured that video calls and breathing exercises are performed together in the form of conference calls.. "Slow Breathing Exercise Training Booklet" and "Slow Breathing Exercise Short Film Video" will be used in the trainings. A calibrated portable digital upper arm sphygmomanometer will be used for heart rate and blood pressure measurement. Groups will be asked to record their own pulse and blood pressure measurements at home.

Data will be collected using the "Patient Information Form", "Mac New Heart Disease Health Related Quality of Life Scale", "VAS Breath Therapy Satisfaction Evaluation Form", "Self-Monitoring Form" and "Patient Follow up Form". Patients will be seen again during the outpatient clinic examination in the fourth and eighth weeks and the effectiveness of slow breathing exercises will be evaluated with data collection forms.

SPSS (IBM Corp., Armonk, NY, USA) program will be used in the analysis of the findings. Before analysis, the normality of the data will be evaluated with the Shapiro-Wilk test. Comparisons between the two groups will be made with descriptive statistics (frequency, percentage, etc.) in the analysis, as well as the Independent Sample t-test (in data with normal distribution) and Mann-Whitney U test (in data that does not show normal distribution) in quantitative data. In comparisons of more than two groups, One-Way Analysis of Variance (One-way ANOVA) or its non-parametric equivalent Kruskal-Wallis test will be used. Paired Samples t-Test or its non-parametric equivalent Wilcoxon test will be used to test the difference in quantitative repeated measurements. Qualitative comparisons between groups will be made with the Chi-Square test. Results, significance in the 95% confidence interval will be evaluated under p<0.05.

Conditions

Slow Breathing; Acute Myocardial Infarction

Keywords

Blood Pressure; Pulse; Percutaneous Coronary Intervention; Quality of Life; Slow Breathing Exercise

Study Design

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

Study Groups

Slow breathing exercise training

Slow breathing exercise training will be given to patients in the experimental group. After discharge, patients will be asked to do slow breathing exercises twice a day for 10 minutes every day for eight weeks. Daily and/or weekly online, weekday, weekend, daytime, evening, video phone calls will be made with patients who are discharged at the end of the training to practice the slow breathing exercise every day according to the patients' demand. It will be provided that breathing exercises will be performed together with a video call in the form of a conference call. Patients will be asked to take measurements a total of two days a week, one day on weekdays and one day on weekends, in the morning, after a light breakfast, at least five minutes of rest and breathing exercises. Pulse and blood pressure measurements at home on weekdays will be asked to be measured Decouply from breathing exercise, and on weekends before and after breathing exercise.

Group Type: EXPERIMENTAL

Slow breathing exercise training

Intervention Type: BEHAVIORAL

Slow breathing exercise training will be given by the researcher in a single one-hour session in the meeting room of the unit 24 hours after the PCI and/or the next day. After a 20-minute silent rest in the training, patients will be asked to breathe slowly through the nostrils for 4 seconds and slowly exhale through the mouth for 6 seconds to reach 6-8 breaths/min. The patient will rest for 5 seconds after every 6 slow breaths. During the training period, a stopwatch will be used by observing the patient's chest and abdominal movements in order to determine whether the patients have reached the required respiratory rate.

Control group

In the control group, patients will be shown and told self-blood pressure and pulse measurement at home at discharge. A reminder text message will be sent to the mobile phones of patients for blood pressure and pulse measurement at home. The control group will also be asked to perform their own blood pressure and pulse monitoring at home and record a Self-Monitoring Form (for the Control group).During home follow-up, patients will be sent reminder text messages to their mobile phones two days a week. According to the request of patients, daily and/or weekly online, weekdays, weekends, daytime, evening, phone calls will be made to measure pulse and blood pressure values two days a week.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Slow breathing exercise training

Slow breathing exercise training will be given by the researcher in a single one-hour session in the meeting room of the unit 24 hours after the PCI and/or the next day. After a 20-minute silent rest in the training, patients will be asked to breathe slowly through the nostrils for 4 seconds and slowly exhale through the mouth for 6 seconds to reach 6-8 breaths/min. The patient will rest for 5 seconds after every 6 slow breaths. During the training period, a stopwatch will be used by observing the patient's chest and abdominal movements in order to determine whether the patients have reached the required respiratory rate.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Young adult patients between the ages of 18-65,
• Patients who have not received fibrinolytic therapy before or simultaneously with Percutaneous Coronary Intervention (PCI) procedure,
• Patients who have passed 24 hours after the PCI procedure,
• Patients with a pulse > 60/min (whether or not beta blockers are used after PCI),
• Patients without rhythm problems,
• Patients with hypertension (systolic blood pressure 140-179 mmHg, diastolic blood pressure 90-109 mmHg), (whether or not they use antihypertensive and beta blocker drugs),
• Patients without a diagnosis of mental or psychiatric disease,
• Patients who have the materials to watch the breathing exercise video,
• Patients who can receive reminder messages and make video calls (with devices such as a smartphone, computer, tablet, etc.),
• Patients with a portable blood pressure monitor suitable for pulse and blood pressure measurement during home monitoring (the necessary equipment will be provided within the scope of the TUBITAK project),
• Patients without hearing or visual impairment,
• Patients who can read and write
• Patients who can communicate,
• Patients without language problems,
• Patients who volunteer and indicate this verbally and in writing

Exclusion Criteria

• Patients with elective/appointed appointments for whom PCI is planned in advance,
• Patients whose PCI procedure failed,
• Patients who underwent only thrombus aspiration and balloon angioplasty during the PCI procedure,
• Patients who have previously undergone PCI and at least one year has not passed since,
• Patients who do not comply with planned interventions,
• Patients who do not volunteer to participate in the study,
• Patients with physical limitations and respiratory distress who cannot do breathing exercises,
• Patients with rhythm problems,
• Patients with diseases that can increase heart rate (anemia, hyperthyroidism, hyperthermia, infection),
• Patients who are morbidly obese (Body Mass Index > 40 kg/m2),
• Patients with hearing impairment,
• Patients with mental disabilities or perception problems,
• Patients who have previously received breathing therapy training will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Melike Çelik

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melike CELIK, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Selda CELIK, Assoc.Prof.

Role: STUDY_DIRECTOR

University of Health science

MELİKE CELİK, Lecturer

Role: STUDY_CHAIR

905321562205

Locations

Istanbul Provincial Directorate of Health Koşuyolu High Specialization Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Melike CELIK, Lecturer

Role: CONTACT

Phone: 905321562205

Email: melike.celik@marmara.edu.tr

Selda CELIK, Assoc.Prof.

Role: CONTACT

Phone: 905332253856

Email: selda.celik@sbu.edu.tr

Facility Contacts

CELIK, MELIKE

Role: primary

Other Identifiers

223S237

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TUBITAKprojectnumbered223S237

Identifier Type: -

Identifier Source: org_study_id