NCT06356896

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

March 7, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

coronary artery bypassanxietysymptomsleep

Outcome Measures

Primary Outcomes (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.

    10 minutes(5th day after surgery)

Secondary Outcomes (1)

  • richards champbell sleep quality scale

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

Other Outcomes (2)

  • state anxiety inventory

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

  • Personal information form

    2 minutes(one day before surgery)

Study Arms (2)

experimental: experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

The standard procedure will be applied to the control group without any intervention.

Interventions

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.

experimental: experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • If the patient develops any complications during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Serap SAYAR, PhD

    KTO Karatay University

    STUDY DIRECTOR
  • Havva Nur YALICI, MSc Student

    Konya City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serap SAYAR, PhD

CONTACT

Havva Nur YALICI, MSc Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant) Single Blinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

March 7, 2024

First Posted

April 10, 2024

Study Start

March 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

The researcher at Konya City Hospital will collect the data.

Locations