AzTrials
AzTrials

Coronary ArteryNCT06356896

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

A study testing diaphragmatic breathing exercise in people with Coronary Artery and Anxiety, run by KTO Karatay University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery, Anxiety, Symptom
What is being tested?
diaphragmatic breathing exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2024to 1 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

  • If the patient develops any complications during the study

Trial locations and contacts

1 site in 1 country.

Serap SAYAR, PhD contact

05059102994

oranserap@gmail.com

Havva Nur YALICI, MSc Student contact

05413386593

havvanur.yalici2017@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Konya City Hospital

    Konya, Karatay, 42020

    Serap SAYAR, PhD, 05059102994, oranserap@gmail.com

    Havva Nur YALICI, Nurse, 05413386593, havvanur.yalici2017@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
diaphragmatic breathing exercise
Keywords
coronary artery bypass, anxiety, symptom, sleep
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diaphragmatic breathing exerciseBehavioural

    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.

Study groups in NCT06356896
Study groupRoleWhat they receive
experimental: experimental groupExperimentalDiaphragmatic 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.
Receives: Behavioral: diaphragmatic breathing exercise
control groupNo interventionThe standard procedure will be applied to the control group without any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiovascular surgery symptom inventory

    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.

    Measured: 10 minutes(5th day after surgery)

Secondary outcomes (1)
  1. richards champbell sleep quality scale

    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.

    Measured: 10 minutes(one day before surgery and the 5th day after surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Adult patients will be divided into two groups: experimental and control groups. Diaphragmatic breathing exercise will be explained to the patients in the experimental group in the preoperative period. In the preoperative period, the sleep, anxiety and symptom levels of the experimental and control groups will be evaluated.In the post-operative period, the experimental group was reminded to do diaphragmatic breathing exercises on the 2nd, 3rd and 4th days.On the 5th post-operative day, sleep, anxiety and symptom severity of the experimental and control groups will be evaluated.
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356896
Sponsor's protocol ID
2023/034
Status last verified
Apr 2024
First submitted
7 Mar 2024
Last updated
10 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The researcher at Konya City Hospital will collect the data.

Questions about this trial

What is this clinical trial studying?

A study testing diaphragmatic breathing exercise in people with Coronary Artery and Anxiety, run by KTO Karatay University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Serap SAYAR, PhD (05059102994, oranserap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiovascular surgery symptom inventory (time frame: 10 minutes(5th day after surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in