Coronary ArteryNCT06356896
The Effect of Diaphragmatic Breathing Exercise on Symptom Severity, Sleep Quality and Anxiety in CABG Patients.
A study testing diaphragmatic breathing exercise in people with Coronary Artery and Anxiety, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the patients' heart muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery, Anxiety, Symptom
- What is being tested?
- diaphragmatic breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Being over 18 years old
- No vision or hearing problems
- Able to speak and understand Turkish
- No mental, psychiatric or neurological disabilities
- Transferred to the clinic on the second postoperative day
- Those who do not have chronic lung disease (COPD, Asthma, Pulmonary CA.. etc.)
- Full orientation to person, place and time
Who cannot join
- If the patient develops any complications during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya City Hospital
Konya, Karatay, 42020
Serap SAYAR, PhD, 05059102994, oranserap@gmail.com
Havva Nur YALICI, Nurse, 05413386593, havvanur.yalici2017@gmail.com
About this study
Official title: The Effect of Diaphragmatic Breathing Exercise Applied to Patients Undergoing Coronary Artery Bypass Surgery on Symptom Severity, Sleep Quality and Anxiety.
Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the patients' heart muscle. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit patients' daily activities, negatively affect their quality of life, and make the rehabilitation process difficult. Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency. Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties. Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up. At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation. This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery.
Read the detailed description
Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the heart muscle of patients. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit the daily activities of patients, negatively affect their quality of life and make the rehabilitation process difficult.Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency.Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties.After CABC, patients' sleep quality can often be negatively affected. Factors such as shortness of breath, pain, discomfort, and time spent in a hospital environment can cause decreases in sleep duration and quality. Sleep disorders can affect patients' rest and recovery processes, reduce their overall quality of life, and prolong the recovery process. Diaphragmatic breathing exercise may be a potential strategy to improve sleep quality. This exercise, which involves deep and controlled breathing as well as relaxation and stress reduction techniques, can improve sleep patterns by promoting relaxation.Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up.Coronary artery bypass surgery (CABG) is a commonly used surgical method in the treatment of narrowing of the coronary arteries. This surgical procedure aims to improve blood circulation of the heart muscle and improves patients' quality of life. However, increased anxiety levels may be observed in patients undergoing CABG in the postoperative period. This anxiety can affect patients' rehabilitation process and negatively impact their quality of life.Therefore, effective interventions to reduce anxiety in CABG patients are being investigated. Anxiety is a common condition in patients undergoing CABG surgery and may increase in the post-surgical period. This anxiety can be caused by a variety of factors, including physical discomfort, the hospital environment, fear, uncertainty, and concerns about the future. Therefore, it is important to develop an effective intervention to reduce anxiety in CABG patients.Diaphragmatic breathing exercise is a technique used to control breathing and encourage deep breathing. This exercise is known to have positive effects such as reducing stress, providing relaxation and reducing anxiety. Therefore, it is thought that diaphragmatic breathing exercise may have a positive effect on anxiety in CABG patients. This exercise provides relief and relaxation by encouraging the correct use of respiratory muscles. Diaphragmatic breathing exercise involves rhythmically controlling breathing and expanding and contracting the abdominal area. This process helps reduce stress responses by activating the sympathetic nervous system and provide relief by activating the parasympathetic nervous system.The effect of diaphragmatic breathing exercise on anxiety is based on several mechanisms. Breathing deeply and slowly increases the amount of oxygen and reduces the amount of carbon dioxide in the body. This provides relief by reducing the release of cortisol and adrenaline, the body's stress hormones.At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation.This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. Managing symptoms and improving patients' quality of life after CABC has become an important goal. Research in this field shows that diaphragmatic breathing exercise can reduce symptoms after CABC and reduce patients' general anxiety. However, the information in the literature shows that there are not enough and comprehensive studies on this subject. Therefore, this thesis study aims to evaluate the effect of diaphragmatic breathing exercise on symptom severity, sleep quality and anxiety in patients undergoing CABC. The study is conducted to evaluate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. This study aims to investigate the effectiveness of the care provided by nurses to patients after CABC and its contribution to increasing patient outcomes.The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery.The findings of this study may offer an effective intervention strategy that can be used in nursing practice in the care of patients after CABC. Diaphragmatic breathing exercise is expected to reduce post-CABC symptoms, improve patients' quality of life, and improve their general anxiety. Nurses can play an important role in implementing this intervention, guiding and supporting patients. Additionally, this study is concerned with identifying an intervention that has the potential to alleviate post-CABC symptoms. Reduction of symptoms, While patients' quality of life increases, their anxiety may decrease. This study has the potential to provide an effective intervention strategy that nurses can use to guide and support patients after CABC.
- Conditions
- Coronary Artery, Anxiety, Symptom, Sleep
- Being tested
- diaphragmatic breathing exercise
- Keywords
- coronary artery bypass, anxiety, symptom, sleep
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic breathing exerciseBehavioural
Each patient's relative should not be in the room, the curtains/screens around the patient bed should be closed, and interventions should be applied in a comfortable environment care will be taken to ensure that the room is quiet and calm. During the first 5 minutes, researchers will explain with pictures how the exercise is done and show it to the patient. The patient will then be asked to perform the exercise for 10 minutes under the supervision of the researchers. If the patient has performed the DBE correctly, the procedure will be discontinued. Otherwise, the patient will be asked to practice for another 5 minutes. If at the end of this period the patient still cannot perform the exercise correctly, he will be removed from the sample. DBE will be performed according to Cleveland Clinic guidelines.
| Study group | Role | What they receive |
|---|---|---|
| experimental: experimental group | Experimental | Diaphragmatic breathing exercise will be explained practically to the patients in the experimental group in the preoperative period. Anxiety, sleep and symptom levels will be evaluated. 2-3-4 in the post-operative period. On the 5th day, the patient will be encouraged to do diaphragmatic breathing exercises. On the 5th day, anxiety, sleep and symptom levels will be evaluated. Receives: Behavioral: diaphragmatic breathing exercise |
| control group | No intervention | The standard procedure will be applied to the control group without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular surgery symptom inventory
It will be applied to adult patients in the intervention and control groups on the 5th post-operative day. Scores between 0 and 140 can be obtained from the inventory. As the scores increase, symptom severity increases.
Measured: 10 minutes(5th day after surgery)
Secondary outcomes (1)
richards champbell sleep quality scale
Patients in the experimental and control groups will be evaluated on the 5th day of pre-op and post-op.A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep. As the scale score increases, the sleep quality of the patients also increases.
Measured: 10 minutes(one day before surgery and the 5th day after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult patients will be divided into two groups: experimental and control groups. Diaphragmatic breathing exercise will be explained to the patients in the experimental group in the preoperative period. In the preoperative period, the sleep, anxiety and symptom levels of the experimental and control groups will be evaluated.In the post-operative period, the experimental group was reminded to do diaphragmatic breathing exercises on the 2nd, 3rd and 4th days.On the 5th post-operative day, sleep, anxiety and symptom severity of the experimental and control groups will be evaluated.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Sayar, KTO Karatay University
- Investigators
- Serap SAYAR, PhD, Study director, KTO Karatay UniversityHavva Nur YALICI, MSc Student, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356896
- Sponsor's protocol ID
- 2023/034
- Status last verified
- Apr 2024
- First submitted
- 7 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researcher at Konya City Hospital will collect the data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diaphragmatic Breathing Exercise Applied to Patients Undergoing Coronary Artery Bypass Surgery on Symptom Severity, Sleep Quality and Anxiety.
- ClinicalTrials.gov ID
- NCT06356896
- Acronym / sponsor ID
- 2023/034
- Conditions
- Coronary Artery, Anxiety, Symptom, Sleep
- Keywords
- coronary artery bypass, anxiety, symptom, sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 10 Apr 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.
Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the patients' heart muscle. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit patients' daily activities, negatively affect their quality of life, and make the rehabilitation process difficult. Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency. Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties. Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up. At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation. This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery.
Detailed description
Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the heart muscle of patients. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit the daily activities of patients, negatively affect their quality of life and make the rehabilitation process difficult.Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency.Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties.After CABC, patients' sleep quality can often be negatively affected. Factors such as shortness of breath, pain, discomfort, and time spent in a hospital environment can cause decreases in sleep duration and quality. Sleep disorders can affect patients' rest and recovery processes, reduce their overall quality of life, and prolong the recovery process. Diaphragmatic breathing exercise may be a potential strategy to improve sleep quality. This exercise, which involves deep and controlled breathing as well as relaxation and stress reduction techniques, can improve sleep patterns by promoting relaxation.Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up.Coronary artery bypass surgery (CABG) is a commonly used surgical method in the treatment of narrowing of the coronary arteries. This surgical procedure aims to improve blood circulation of the heart muscle and improves patients' quality of life. However, increased anxiety levels may be observed in patients undergoing CABG in the postoperative period. This anxiety can affect patients' rehabilitation process and negatively impact their quality of life.Therefore, effective interventions to reduce anxiety in CABG patients are being investigated. Anxiety is a common condition in patients undergoing CABG surgery and may increase in the post-surgical period. This anxiety can be caused by a variety of factors, including physical discomfort, the hospital environment, fear, uncertainty, and concerns about the future. Therefore, it is important to develop an effective intervention to reduce anxiety in CABG patients.Diaphragmatic breathing exercise is a technique used to control breathing and encourage deep breathing. This exercise is known to have positive effects such as reducing stress, providing relaxation and reducing anxiety. Therefore, it is thought that diaphragmatic breathing exercise may have a positive effect on anxiety in CABG patients. This exercise provides relief and relaxation by encouraging the correct use of respiratory muscles. Diaphragmatic breathing exercise involves rhythmically controlling breathing and expanding and contracting the abdominal area. This process helps reduce stress responses by activating the sympathetic nervous system and provide relief by activating the parasympathetic nervous system.The effect of diaphragmatic breathing exercise on anxiety is based on several mechanisms. Breathing deeply and slowly increases the amount of oxygen and reduces the amount of carbon dioxide in the body. This provides relief by reducing the release of cortisol and adrenaline, the body's stress hormones.At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation.This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. Managing symptoms and improving patients' quality of life after CABC has become an important goal. Research in this field shows that diaphragmatic breathing exercise can reduce symptoms after CABC and reduce patients' general anxiety. However, the information in the literature shows that there are not enough and comprehensive studies on this subject. Therefore, this thesis study aims to evaluate the effect of diaphragmatic breathing exercise on symptom severity, sleep quality and anxiety in patients undergoing CABC. The study is conducted to evaluate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. This study aims to investigate the effectiveness of the care provided by nurses to patients after CABC and its contribution to increasing patient outcomes.The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery.The findings of this study may offer an effective intervention strategy that can be used in nursing practice in the care of patients after CABC. Diaphragmatic breathing exercise is expected to reduce post-CABC symptoms, improve patients' quality of life, and improve their general anxiety. Nurses can play an important role in implementing this intervention, guiding and supporting patients. Additionally, this study is concerned with identifying an intervention that has the potential to alleviate post-CABC symptoms. Reduction of symptoms, While patients' quality of life increases, their anxiety may decrease. This study has the potential to provide an effective intervention strategy that nurses can use to guide and support patients after CABC.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Adult patients will be divided into two groups: experimental and control groups. Diaphragmatic breathing exercise will be explained to the patients in the experimental group in the preoperative period. In the preoperative period, the sleep, anxiety and symptom levels of the experimental and control groups will be evaluated.In the post-operative period, the experimental group was reminded to do diaphragmatic breathing exercises on the 2nd, 3rd and 4th days.On the 5th post-operative day, sleep, anxiety and symptom severity of the experimental and control groups will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| experimental: experimental group | Experimental | Behavioral: diaphragmatic breathing exerciseDiaphragmatic breathing exercise will be explained practically to the patients in the experimental group in the preoperative period. Anxiety, sleep and symptom levels will be evaluated. 2-3-4 in the post-operative period. On the 5th day, the patient will be encouraged to do diaphragmatic breathing exercises. On the 5th day, anxiety, sleep and symptom levels will be evaluated. |
| control group | No intervention | –The standard procedure will be applied to the control group without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Being over 18 years old
Key exclusion criteria (1 listed)
- If the patient develops any complications during 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 |
|---|---|---|
| diaphragmatic breathing exerciseEach patient's relative should not be in the room, the curtains/screens around the patient bed should be closed, and interventions should be applied in a comfortable environment care will be taken to ensure that the room is quiet and calm. During the first 5 minutes, researchers will explain with pictures how the exercise is done and show it to the patient. The patient will then be asked to perform the exercise for 10 minutes under the supervision of the researchers. If the patient has performed the DBE correctly, the procedure will be discontinued. Otherwise, the patient will be asked to practice for another 5 minutes. If at the end of this period the patient still cannot perform the exercise correctly, he will be removed from the sample. DBE will be performed according to Cleveland Clinic guidelines. | Behavioural | experimental: experimental group |
Primary outcome
cardiovascular surgery symptom inventory
Time frame: 10 minutes(5th day after surgery)
It will be applied to adult patients in the intervention and control groups on the 5th post-operative day. Scores between 0 and 140 can be obtained from the inventory. As the scores increase, symptom severity increases.
1 secondary outcome
richards champbell sleep quality scale
Time frame: 10 minutes(one day before surgery and the 5th day after surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No. The researcher at Konya City Hospital will collect the data.
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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.
Serap SAYAR, PhD study director
KTO Karatay University
Havva Nur YALICI, MSc Student principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragmatic breathing exercise in people with Coronary Artery and Anxiety, run by KTO Karatay 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serap SAYAR, PhD (05059102994, oranserap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular surgery symptom inventory (time frame: 10 minutes(5th day after surgery)). 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 10 Apr 2024.