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CompletedNCT06602128Updated Dec 5, 2024

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

An interventional study of Experimental: Breathing Exercise Application Group in Breathing Exercises and Coronary Angiography, sponsored by Kahramanmaraş İstiklal University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Kahramanmaraş İstiklal University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Breathing Exercises
  • Coronary Angiography

Keywords

  • Vital Signs
  • Pain
  • Stress
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 90 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Kahramanmaraş İstiklal University is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    There will be no intervention for individuals in this group.

Interventions

  • BehavioralExperimental: Breathing Exercise Application Group

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 minutes before coronary angiography

  2. 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.

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

  3. Vital Signs Recording Form- Saturation

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

    Time frame: 30 minutes before coronary angiography

  4. Vital Signs Recording Form- Saturation

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

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

  5. Vital Signs Recording Form- Pulse values

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

    Time frame: 30 minutes before coronary angiography

  6. Vital Signs Recording Form- Pulse values

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

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

  7. 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.

    Time frame: 30 minutes before coronary angiography

  8. 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.

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

  9. 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.

    Time frame: 30 minutes before coronary angiography

  10. 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.

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

07

Study locations

1 site
  • Kahramanmaraş Istiklal Universty
    Kahramanmaraş, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06602128
Lead sponsor
Kahramanmaraş İstiklal University
Responsible party
Yasemin Sazak (Assistant Professor, Kahramanmaraş İstiklal University) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 18, 2024
Primary completion
Nov 25, 2024
Completion
Nov 25, 2024
Last update
Dec 5, 2024

Study contacts

Sevinç Meşe
study chair · Kahramanmaraş İstiklal University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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