The Effect of Diaphragmatic Breathing Exercise on Symptom Severity, Sleep Quality and Anxiety in CABG Patients.

April 4, 2024 updated by: Serap Sayar, KTO Karatay University

The Effect of Diaphragmatic Breathing Exercise Applied to Patients Undergoing Coronary Artery Bypass Surgery on Symptom Severity, Sleep Quality and Anxiety.

Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the patients' heart muscle. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit patients' daily activities, negatively affect their quality of life, and make the rehabilitation process difficult. Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency. Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties. Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up. At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation. This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the heart muscle of patients. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit the daily activities of patients, negatively affect their quality of life and make the rehabilitation process difficult.Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency.Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties.After CABC, patients' sleep quality can often be negatively affected. Factors such as shortness of breath, pain, discomfort, and time spent in a hospital environment can cause decreases in sleep duration and quality. Sleep disorders can affect patients' rest and recovery processes, reduce their overall quality of life, and prolong the recovery process. Diaphragmatic breathing exercise may be a potential strategy to improve sleep quality. This exercise, which involves deep and controlled breathing as well as relaxation and stress reduction techniques, can improve sleep patterns by promoting relaxation.Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up.Coronary artery bypass surgery (CABG) is a commonly used surgical method in the treatment of narrowing of the coronary arteries. This surgical procedure aims to improve blood circulation of the heart muscle and improves patients' quality of life. However, increased anxiety levels may be observed in patients undergoing CABG in the postoperative period. This anxiety can affect patients' rehabilitation process and negatively impact their quality of life.Therefore, effective interventions to reduce anxiety in CABG patients are being investigated. Anxiety is a common condition in patients undergoing CABG surgery and may increase in the post-surgical period. This anxiety can be caused by a variety of factors, including physical discomfort, the hospital environment, fear, uncertainty, and concerns about the future. Therefore, it is important to develop an effective intervention to reduce anxiety in CABG patients.Diaphragmatic breathing exercise is a technique used to control breathing and encourage deep breathing. This exercise is known to have positive effects such as reducing stress, providing relaxation and reducing anxiety. Therefore, it is thought that diaphragmatic breathing exercise may have a positive effect on anxiety in CABG patients. This exercise provides relief and relaxation by encouraging the correct use of respiratory muscles. Diaphragmatic breathing exercise involves rhythmically controlling breathing and expanding and contracting the abdominal area. This process helps reduce stress responses by activating the sympathetic nervous system and provide relief by activating the parasympathetic nervous system.The effect of diaphragmatic breathing exercise on anxiety is based on several mechanisms. Breathing deeply and slowly increases the amount of oxygen and reduces the amount of carbon dioxide in the body. This provides relief by reducing the release of cortisol and adrenaline, the body's stress hormones.At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation.This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. Managing symptoms and improving patients' quality of life after CABC has become an important goal. Research in this field shows that diaphragmatic breathing exercise can reduce symptoms after CABC and reduce patients' general anxiety. However, the information in the literature shows that there are not enough and comprehensive studies on this subject. Therefore, this thesis study aims to evaluate the effect of diaphragmatic breathing exercise on symptom severity, sleep quality and anxiety in patients undergoing CABC. The study is conducted to evaluate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. This study aims to investigate the effectiveness of the care provided by nurses to patients after CABC and its contribution to increasing patient outcomes.The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery.The findings of this study may offer an effective intervention strategy that can be used in nursing practice in the care of patients after CABC. Diaphragmatic breathing exercise is expected to reduce post-CABC symptoms, improve patients' quality of life, and improve their general anxiety. Nurses can play an important role in implementing this intervention, guiding and supporting patients. Additionally, this study is concerned with identifying an intervention that has the potential to alleviate post-CABC symptoms. Reduction of symptoms, While patients' quality of life increases, their anxiety may decrease. This study has the potential to provide an effective intervention strategy that nurses can use to guide and support patients after CABC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Being over 18 years old

    • No vision or hearing problems
    • Able to speak and understand Turkish
    • No mental, psychiatric or neurological disabilities
    • Transferred to the clinic on the second postoperative day
    • Those who do not have chronic lung disease (COPD, Asthma, Pulmonary CA.. etc.)
    • Full orientation to person, place and time

Exclusion Criteria:

  • If the patient develops any complications during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental: experimental group
Diaphragmatic breathing exercise will be explained practically to the patients in the experimental group in the preoperative period. Anxiety, sleep and symptom levels will be evaluated. 2-3-4 in the post-operative period. On the 5th day, the patient will be encouraged to do diaphragmatic breathing exercises. On the 5th day, anxiety, sleep and symptom levels will be evaluated.
Behavioral: diaphragmatic breathing exercise
Each patient's relative should not be in the room, the curtains/screens around the patient bed should be closed, and interventions should be applied in a comfortable environment care will be taken to ensure that the room is quiet and calm. During the first 5 minutes, researchers will explain with pictures how the exercise is done and show it to the patient. The patient will then be asked to perform the exercise for 10 minutes under the supervision of the researchers. If the patient has performed the DBE correctly, the procedure will be discontinued. Otherwise, the patient will be asked to practice for another 5 minutes. If at the end of this period the patient still cannot perform the exercise correctly, he will be removed from the sample. DBE will be performed according to Cleveland Clinic guidelines.
No Intervention: control group
The standard procedure will be applied to the control group without any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
cardiovascular surgery symptom inventory
Time Frame: 10 minutes(5th day after surgery)
It will be applied to adult patients in the intervention and control groups on the 5th post-operative day. Scores between 0 and 140 can be obtained from the inventory. As the scores increase, symptom severity increases.
10 minutes(5th day after surgery)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
richards champbell sleep quality scale
Time Frame: 10 minutes(one day before surgery and the 5th day after surgery)
Patients in the experimental and control groups will be evaluated on the 5th day of pre-op and post-op.A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep. As the scale score increases, the sleep quality of the patients also increases.
10 minutes(one day before surgery and the 5th day after surgery)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
state anxiety inventory
Time Frame: 10 minutes(one day before surgery and the 5th day after surgery)
It will be applied to the experimental and control groups in the preoperative period and on the 5th post-operative day.A high score on the scale indicates a high level of anxiety; A low score indicates a low level of anxiety.
10 minutes(one day before surgery and the 5th day after surgery)
Personal information form
Time Frame: 2 minutes(one day before surgery)
Personal information form, literature review as a result, it was created by the researchers. This form contains a total of 11 questions including sociodemographic and descriptive characteristics such as the patient's name and surname, age, gender, marital status, education level, presence of chronic disease, alcohol and cigarette consumption.
2 minutes(one day before surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KTO Karatay University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Serap SAYAR, PhD, KTO Karatay University
  • Principal Investigator: Havva Nur YALICI, MSc Student, Konya City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The researcher at Konya City Hospital will collect the data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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