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NCT Number: NCT06602128

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

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.

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Key information

Conditions

Breathing Exercises Coronary Angiography Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaraş Istiklal Universty

Kahramanmaraş, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Breathing Exercise Application Group

Behavioral

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

Primary outcomes

  1. Vital Signs Recording Form-Blood pressure values

    Time frame: 30 minutes before coronary angiography

    It is a form created by the researcher in which the blood pressure values of the patients are recorded.

  2. Vital Signs Recording Form-Blood pressure values

    Time frame: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

    It is a form created by the researcher in which the blood pressure values of the patients are recorded.

  3. Vital Signs Recording Form- Saturation

    Time frame: 30 minutes before coronary angiography

    It is a form created by the researcher in which the saturation values of the patients are recorded.

  4. Vital Signs Recording Form- Saturation

    Time frame: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

    It is a form created by the researcher in which the saturation values of the patients are recorded.

  5. Vital Signs Recording Form- Pulse values

    Time frame: 30 minutes before coronary angiography

    It is a form created by the researcher in which the pulse rates of the patients are recorded.

  6. Vital Signs Recording Form- Pulse values

    Time frame: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

    It is a form created by the researcher in which the pulse rates of the patients are recorded.

  7. Visual Analogy Scale (VAS)

    Time frame: 30 minutes before coronary angiography

    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.

  8. Visual Analogy Scale (VAS)

    Time frame: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

    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.

  9. State-Trait Anxiety Inventory (STAI-I)

    Time frame: 30 minutes before coronary angiography

    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.

  10. State-Trait Anxiety Inventory (STAI-I)

    Time frame: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed

    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.

Sponsors and collaborators

Lead sponsor

Kahramanmaraş İstiklal University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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