Breathing ExercisesNCT06602128
The Effect of Breathing Exercise on Anxiety, Pain and Life Findings in Patients Undergoing Coronary Angiography
A study testing Experimental: Breathing Exercise Application Group in people with Breathing Exercises and Coronary Angiography, run by Kahramanmaraş İstiklal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises, Coronary Angiography
- What is being tested?
- Experimental: Breathing Exercise Application Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2024to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Istiklal Universty
Kahramanmaraş
About this study
Official title: 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.
Read more
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.
- Conditions
- Breathing Exercises, Coronary Angiography
- Being tested
- Experimental: Breathing Exercise Application Group
- Keywords
- Vital Signs, Pain, Stress
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Breathing Exercise Application GroupBehavioural
The Effect of Breathing Exercise on Anxiety, Pain and Life Findings in Patients Undergoing Coronary Angiography
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise Application Group | Experimental | 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. Receives: Behavioral: Experimental: Breathing Exercise Application Group |
| Control group | No intervention | There will be no intervention for individuals in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 15 minutes after the angiography procedure is completed and the patient is taken to bed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Sep 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaraş İstiklal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Sazak, Kahramanmaraş İstiklal University
- Investigators
- Sevinç Meşe, Study chair, Kahramanmaraş İstiklal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602128
- Sponsor's protocol ID
- IstiklalU-YSazak-001
- Status last verified
- Dec 2024
- First submitted
- 13 Sep 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise on Anxiety, Pain and Vital Signs in Patients Undergoing Coronary Angiography: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06602128
- Acronym / sponsor ID
- IstiklalU-YSazak-001
- Conditions
- Breathing Exercises, Coronary Angiography
- Keywords
- Vital Signs, Pain, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kahramanmaraş İstiklal UniversityUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Application Group | Experimental | Behavioral: Experimental: Breathing Exercise Application GroupPatients 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 intervention | –There will be no intervention for individuals in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Breathing Exercise Application GroupThe Effect of Breathing Exercise on Anxiety, Pain and Life Findings in Patients Undergoing Coronary Angiography | Behavioural | Breathing Exercise Application Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevinç Meşe study chair
Kahramanmaraş İstiklal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Breathing Exercise Application Group in people with Breathing Exercises and Coronary Angiography, run by Kahramanmaraş İstiklal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Signs Recording Form-Blood pressure values (time frame: 30 minutes before coronary angiography). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.