Effect of Breathing Exercises Before Coronary Angiography (EBECA)

The Effect of Breathing Exercises Applied to Patients Undergoing Coronary Angiography for the First Time on Anxiety

This research was designed as a pre-test-post-test controlled group randomized controlled interventional study to determine the effect of breathing exercises applied to patients undergoing coronary angiography for the first time on anxiety. Patients were provided with an informed consent form, a personal information form and the Beck Anxiety Scale. The Beck Anxiety Scale was administered to the control group before and after the procedure. In the experimental group, the Beck Anxiety Scale was administered before the procedure, and after providing breathing exercise education and application, the Beck Anxiety Scale was completed after the procedure.

Study Overview

• Status: Completed
• Conditions: Anxiety; Breathing Exercises
• Intervention / Treatment: Behavioral: Breathing Exercises; Other: no intervention/routine procedure

Detailed Description

This research was designed as a pre-test-post-test controlled group randomized controlled interventional study to determine the effect of breathing exercises applied to patients undergoing coronary angiography for the first time on anxiety.

The study population consisted of SBÜ Kartal Koşuyolu Training and Research Hospital.When statistical power analysis was performed according to the G-Power program in the sample group, a minimum of 34 experimental and a minimum of 34 control groups were used, considering data loss, 76 volunteer patients who met the inclusion criteria were studied. Patients were provided with an informed consent form, a personal information form and the Beck Anxiety Scale. The Beck Anxiety Scale was administered to the control group before and after the procedure. In the experimental group, the Beck Anxiety Scale was administered before the procedure, and after providing breathing exercise education and application, the Beck Anxiety Scale was completed after the procedure. The 'Dependent Group T-Test' technique was used for the analysis of data obtained from the scales used in the study, comparing pre-test and post-test scores of the intervention and control groups. Also, the 'Independent Group T-Test' was used for separate comparisons of pre-test and post-test scores of the experimental and control groups.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul
    • Maltepe, İstanbul, Turkey, 34857
      • Maltepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Were between 18-80 years old,
• Had never undergone coronary angiography before,
• Correctly and completely filled out the Beck Anxiety Scale,
• Voluntarily agreed to participate in the study.

Exclusion Criteria:

• Having a psychiatric illness
• Communication problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EBECA; The patients in the intervention group scheduled for angiography were administered the Beck Anxiety Scale, and then they underwent conscious, deep breathing exercises along with synchronized breathing training. The face-to-face teaching and application of the breathing exercises took an average of 15-20 minutes.	Behavioral: Breathing Exercises; The patients in the intervention group scheduled for angiography were administered the Beck Anxiety Scale, and then they underwent conscious, deep breathing exercises along with synchronized breathing training. The face-to-face teaching and application of the breathing exercises took an average of 15-20 minutes. Additionally, routine treatment was applied. For both the intervention and control groups, the Beck Anxiety Scale was administered again after the completion of the coronary angiography procedure, once stabilization was achieved.
Active Comparator: control group; For the patients in the control group who were scheduled for angiography, the Beck Anxiety Scale was administered face-to-face before the procedure, and they were then sent for the procedure after receiving routine treatment without any additional intervention.	Other: no intervention/routine procedure; Beck Anxiety Scale was administered to the control group before coronary angiography. No intervention was performed in between. The routine procedure of the hospital continued. Beck Anxiety Scale was administered again after leaving the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Anxiety Inventory	Patients who completed the Beck Anxiety Inventory were evaluated based on the scores they provided. The options were scored as follows: 'Not at all' option received 0 points, 'Mild' received 1 point, 'Moderate' received 2 points, and 'Severe' received 3 points. Scores were totaled at the end of the test. The evaluation was explained as follows: 8-15 points = Mild anxiety level 16-25 points = Moderate anxiety level 26-63 points = Severe anxiety level	1 year

Collaborators and Investigators

• Sponsor: Maltepe University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2022
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Estimated): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Coronary angiography; Anxiety; Breathing exercises
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Anxiety Disorders
• Other Study ID Numbers: 2023/01-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No