The Effect of Breathing Exercise on Anxiety, Pain and Life Findings in Patients Undergoing Coronary Angiography

The Effect of Breathing Exercise on Anxiety, Pain and Vital Signs in Patients Undergoing Coronary Angiography: A Randomised Controlled Study

This randomised controlled trial will be conducted to evaluate the effect of breathing exercise on anxiety, pain and vital signs in patients undergoing coronary angiography before angiography.

Hypotheses of the study; H11: The anxiety level of the patients who underwent breathing exercise is lower than the patients in the control group.

H12: The pain level of the patients who underwent breathing exercise is lower than the control group H13: The vital signs of the patients who underwent breathing exercises are within normal limits compared to the control group.

In the study, there will be an intervention group in which breathing exercise will be applied and a control group in which no intervention will be applied.

Data will be collected with the pre-test data collection form half an hour before the angiography procedure in patients in the intervention and control groups. Patients in the intervention group will be given breathing exercises, while patients in the control group will not be subjected to any intervention. After the angioplasty procedure, data will be collected from the intervention and control groups with post-test data collection forms.

Study Overview

• Status: Completed
• Conditions: Coronary Angiography; Breathing Exercises
• Intervention / Treatment: Behavioral: Experimental: Breathing Exercise Application Group

Detailed Description

In determining the groups; simple randomisation method will be used in order to form the sample in a way to ensure equal number and random distribution of the two groups. Randomisation will be done by using the website (https://www.randomizer.org). In line with the randomisation list; patients who meet the inclusion criteria will be included in the intervention and control groups. Inclusion in the intervention and control groups will be made by the researchers in line with the randomisation list. In order for the responsible researcher to apply breathing exercises; he/she has a breathing techniques coaching certificate. In the research; triple breathing technique (full yogic breathing) and square breathing technique will be used. Patients will be informed about the research and their written and verbal consent will be obtained. Data will be collected with the pre-test data collection form half an hour before the angiography procedure in patients in the intervention and control groups. Patients in the intervention group will be given breathing exercises, while patients in the control group will not be subjected to any intervention. The breathing exercise will be performed as a single session and will last approximately 15-20 minutes. After the angioplasty procedure, data will be collected from the intervention and control groups with post-test data collection forms.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaraş, Turkey
    • Kahramanmaraş Istiklal Universty

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients undergoing coronary angiography for the first time
• Over 18 years of age
• No respiratory distress
• No problems with communication
• Volunteering to be included in the study.

Exclusion Criteria:

• Taking any medication to suppress anxiety symptoms
• Patients undergoing emergency coronary angiography and/or patients complaining of chest pain
• Patients on antihypertensive treatment before the procedure due to hypertension
• Patients who underwent emergency intervention during coronary angiography, surgical procedure and intensive care unit for follow-up were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; There will be no intervention for individuals in this group.
Experimental: Breathing Exercise Application Group; Patients in the breathing exercise practice group will have breathing exercise practice for 15-20 minutes half an hour before the angiography procedure. The breathing exercise application will be applied to the patients face to face by the researcher.	Behavioral: Experimental: Breathing Exercise Application Group; The Effect of Breathing Exercise on Anxiety, Pain and Life Findings in Patients Undergoing Coronary Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Signs Recording Form-Blood pressure values	It is a form created by the researcher in which the blood pressure values of the patients are recorded.	30 minutes before coronary angiography
Vital Signs Recording Form-Blood pressure values	It is a form created by the researcher in which the blood pressure values of the patients are recorded.	Within 15 minutes after the angiography procedure is completed and the patient is taken to bed
Vital Signs Recording Form- Saturation	It is a form created by the researcher in which the saturation values of the patients are recorded.	30 minutes before coronary angiography
Vital Signs Recording Form- Saturation	It is a form created by the researcher in which the saturation values of the patients are recorded.	Within 15 minutes after the angiography procedure is completed and the patient is taken to bed
Vital Signs Recording Form- Pulse values	It is a form created by the researcher in which the pulse rates of the patients are recorded.	30 minutes before coronary angiography
Vital Signs Recording Form- Pulse values	It is a form created by the researcher in which the pulse rates of the patients are recorded.	Within 15 minutes after the angiography procedure is completed and the patient is taken to bed
Visual Analogy Scale (VAS)	It is a 10 cm ruler that reflects the minimum and maximum state of pain by using it horizontally or vertically. '0' indicates painlessness and "10" indicates the most severe pain. The patient marks the intensity of pain felt on this ruler.	30 minutes before coronary angiography
Visual Analogy Scale (VAS)	It is a 10 cm ruler that reflects the minimum and maximum state of pain by using it horizontally or vertically. '0' indicates painlessness and "10" indicates the most severe pain. The patient marks the intensity of pain felt on this ruler.	Within 15 minutes after the angiography procedure is completed and the patient is taken to bed
State-Trait Anxiety Inventory (STAI-I)	The scale developed by Spielberg et al. (1964) was adapted into Turkish by Öner and Le Compte (1974-1977). The reliability of the scale is determined between 0.83 and 0.92 and it requires the person to understand his/her situation at certain times and conditions and to mark one of the preferences '1 (Not at all), 2 (A little), 3 (Very), 4 (Completely)' according to its severity. The total score obtained from the scale varies between 20-80 and 20-39 indicates mild anxiety level, 40-59 indicates moderate anxiety level, 60-79 indicates high anxiety level and 80 points indicates panic anxiety level.	30 minutes before coronary angiography
State-Trait Anxiety Inventory (STAI-I)	The scale developed by Spielberg et al. (1964) was adapted into Turkish by Öner and Le Compte (1974-1977). The reliability of the scale is determined between 0.83 and 0.92 and it requires the person to understand his/her situation at certain times and conditions and to mark one of the preferences '1 (Not at all), 2 (A little), 3 (Very), 4 (Completely)' according to its severity. The total score obtained from the scale varies between 20-80 and 20-39 indicates mild anxiety level, 40-59 indicates moderate anxiety level, 60-79 indicates high anxiety level and 80 points indicates panic anxiety level.	Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

Collaborators and Investigators

• Sponsor: Kahramanmaraş İstiklal University
• Investigators: Study Chair: Sevinç Meşe, Kahramanmaraş İstiklal University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Stress; Vital Signs
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: IstiklalU-YSazak-001

Drug and device information, study documents

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