The Effect of Breathing Exercise on Anxiety, Pain and Life Findings in Patients Undergoing Coronary Angiography
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
September 13, 2024
CompletedStudy Start
First participant enrolled
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2024
CompletedDecember 5, 2024
December 1, 2024
2 months
September 13, 2024
December 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
Study Arms (2)
Breathing Exercise Application Group
EXPERIMENTALPatients 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.
Control group
NO INTERVENTIONThere will be no intervention for individuals in this group.
Interventions
The Effect of Breathing Exercise on Anxiety, Pain and Life Findings in Patients Undergoing Coronary Angiography
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kahramanmaraş Istiklal Universty
Kahramanmaraş, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sevinç Meşe
Kahramanmaraş İstiklal University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The post-test measurements will be collected by a nurse working in the angiography ward who is not connected with the study.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 13, 2024
First Posted
September 19, 2024
Study Start
September 18, 2024
Primary Completion
November 25, 2024
Study Completion
November 25, 2024
Last Updated
December 5, 2024
Record last verified: 2024-12