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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06239181
Other study ID # 2023/01-06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2022
Est. completion date June 20, 2023

Study information

Verified date January 2024
Source Maltepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date June 20, 2023
Est. primary completion date June 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Turkey Maltepe University Maltepe Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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