NCT06239181

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

November 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 17, 2024

Last Update Submit

January 26, 2024

Conditions

Keywords

Coronary angiographyBreathing exercisesAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

EBECA

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

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.

EBECA

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.

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having a psychiatric illness
  • Communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University

Maltepe, Istanbul, 34857, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study included 2 groups, experimental and control. The patients in the experimental group were administered the beck anxiety scale before coronary angiography. the patients in the experimental group were given breathing exercises by the researcher for 15-20 minutes. the beck anxiety scale was reapplied after the procedure. the patients in the control group were not administered any application and the beck anxiety scale was reapplied after the procedure.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 2, 2024

Study Start

November 20, 2022

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

February 2, 2024

Record last verified: 2024-01

Locations