Heart; Surgery, Heart, Functional Disturbance as ResultNCT05902052
Development of Open Heart Surgery Patient Care Protocol and Its Effect on Post-sternotomy Pain
A study testing Care Protocol in people with Heart; Surgery, Heart, Functional Disturbance as Result and Pain, Postoperative, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Open heart surgery method is generally used in the treatment of cardiovascular diseases. Sternotomy is the process of opening the sternum. After sternotomy, individuals experience ongoing pain in the anterior thorax. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Postoperative, Nursing Caries
- What is being tested?
- Care Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 31 Dec 2023
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with sternotomy who underwent Coronary Artery Bypass Graft surgery,
- Patient with sternotomy who underwent valve surgery,
- Being 18 years or older,
- Volunteering to participate in the research,
- Being at a level to adequately answer the questions asked cognitively,
- Experiencing pain at least once after the surgery,
- No complications (unable to wean from mechanical ventilator support, inability to discontinue inotropic support) until the period of transfer to the postoperative service.
Who cannot join
- Desiring to leave the study group during the conduct of the research,
- Delirium development in the patient during the conduct of the study,
- The patient for whom emergency surgery has been decided.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Atatürk Training and research hospital
Izmir, 35000
About this study
Official title: Master of Science, Registery Nurse
Open heart surgery method is generally used in the treatment of cardiovascular diseases. Sternotomy is the process of opening the sternum. After sternotomy, individuals experience ongoing pain in the anterior thorax. Despite developing pain methods and treatments, individuals undergoing cardiovascular surgery suffer from pain that cannot be managed well. Patients undergoing cardiac surgery experience severe pain for the first 48 hours and are in intensive care during this period. Pain is the most important stress factor for intensive care patients. The nurse and health care team should play a key role and take an active role in the management and evaluation of pain. However, there are not enough studies trying to define the role of the nurse in the management of postoperative pain. Protocols are used to provide pain management and routine pain assessment in intensive care units. The use of protocols provides maximum care to the patient, while reducing the cost. It also ensures the patient's participation in the treatment. While protocols ensure that practices are converted into evidence-based ones, they also prevent disruptions in treatment. As a result, management of the pain experiences of patients with sternotomy who underwent open heart surgery in the intensive care unit with the developed protocol; It will guide the improvement and development of pain management. It is thought that the protocol will address the pain of individuals undergoing open heart surgery in a holistic way. In addition, no study has been found in the literature that includes the development of a protocol for the pain of intensive care patients undergoing open heart surgery. For this reason, it is thought that the study will shed light on the literature by being a resource in the management and improvement of pain.
Read the detailed description
In this study, it is aimed to develop the open heart surgery patient care protocol and to examine its effect on the pain that develops after sternotomy. The research is planned to be carried out on the patients in the Cardiovascular Surgery Intensive Care Unit of Research Hospital. The sample size of this study was decided by power analysis. The G-Power statistics program is based on Type 1 error 0.05 and 80% power. In the power analysis of Akbayrak and Tosun's (2002) thesis study, using the results showing the average score of the satisfaction level of the patients with and without the care protocol, the sample size was determined as 17 patients for each group and 34 patients in total. However, in order to meet the parametric test assumptions, it was decided to include at least 30 people in each group.
- Conditions
- Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Postoperative, Nursing Caries
- Being tested
- Care Protocol
- Keywords
- Heart Surgery, pain, sternotomy, protocol, nursing
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care ProtocolOther
Evaluation of patients' pain in the extubated period with the Visual Anolog Scale Active participation of the patient in pain reporting Regular questioning of the patient's pain Questioning pain at rest and movement Implementing nursing interventions in painful condition (VAS≤ 4)
| Study group | Role | What they receive |
|---|---|---|
| Open Heart Surgery Patient Care Protocol | Experimental | Specific Practices for Pain in the Protocol
* Evaluation of patients' pain in the extubated period with the Visual Anolog Scale
* Active participation of the patient in pain reporting
* Regular questioning of the patient's pain
* Questioning pain at rest and movement
* Implementing nursing interventions in painful condition (VAS≤ 4) Receives: Other: Care Protocol |
| Standart Care Protocol | No intervention | Standard care of intensive care will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale
Measured: 3 days
Scale for Evaluation of the Quality of Care Given to the Patient in Relief of Postoperative Pain
The scale consists of 14 items and has 3 sub-dimensions related to nursing interventions, pain management and environment. Likert type scale was used in the evaluation. 1 means "strongly disagree" and 5 means "strongly agree". The scale Cronbach's coefficient was 0.81 and the main score obtained from the scale was 45.8 ± 10.8. The scale is a reliable and valid instrument in Turkish language.
Measured: Just before being transferred to intensive care
Analgesic use
Number of analgesic use
Measured: 3 days
Type of analgesic
Type of analgesic
Measured: 3 days
Secondary outcomes (8)
Anxiety
State Anxiety Scale The scale consists of a total of 20 items and each item is evaluated as (1) none, (2) a little, (3) a lot, (4) completely. There are direct and reversed statements in the scale. Positive emotions are defined by inverted statements, and those with a weight of 1 turn into a 4 in a rating, and a weight of 4 turns into a 1. In reversed statements, answers with a value of 1 indicate high anxiety, and those with a value of 4 indicate low anxiety. The total score of the reversed statements is subtracted from the calculated direct statement score, and the unchanged value 50 is added to the resulting number. The total score is between 20-80. According to the score calculated on the scale, 0-19 means no anxiety, 20-39 means mild, 40-59 moderate, 60-79 high anxiety.
Measured: Before going into surgery, Just before being transferred to intensive care
Blood pressure
Measuring arterial blood pressure Systolic blood pressure (the first and higher number) measures pressure inside your arteries when the heart beats.
Diastolic blood pressure (the second and lower number) measures the pressure inside the artery when the heart rests between beats.
Measured: 3 days
respiratory
respiratory rate
Measured: 3 days
Fever
Temperature measurement. A fever is a body temperature that is higher than normal. A normal temperature can vary from person to person, but it is usually around 98.6 °F (37 °C).
Measured: 3 days
Heart rate
Heart rate measurement. A normal resting heart rate for adults ranges from 60 to 100 beats per minute.
Measured: 3 days
Oxygen Saturation
Oxygen saturation can be measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level. A pulse oximeter can measure oxygen saturation. It is a noninvasive device placed over a person's finger. It measures light wavelengths to determine the ratio of the current levels of oxygenated hemoglobin to deoxygenated hemoglobin. The use of pulse oximetry has become a standard of care in medicine.
Measured: 3 days
Partial pressure of carbon dioxide
Blood gases are a measurement of how much oxygen and carbon dioxide are in your blood. They also determine the acidity (pH) of your blood. The partial pressure of carbon dioxide (PCO2) is the measure of carbon dioxide within arterial or venous blood. It often serves as a marker of sufficient alveolar ventilation within the lungs. Generally, under normal physiologic conditions, the value of PCO2 ranges between 35 to 45 mmHg, or 4.7 to 6.0 kPa.
Measured: 3 days
Partial pressure of oxygen
Blood gases are a measurement of how much oxygen and carbon dioxide are in your blood. They also determine the acidity (pH) of your blood.Partial pressure of oxygen (PaO2): 75 to 100 millimeters of mercury (mm Hg), or 10.5 to 13.5 kilopascal (kPa)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Dec 2023
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Surgery, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necibe Dağcan, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902052
- Sponsor's protocol ID
- KutahyaHSU-NECİBE-DAĞCAN-0001
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master of Science, Registery Nurse
- ClinicalTrials.gov ID
- NCT05902052
- Acronym / sponsor ID
- KutahyaHSU-NECİBE-DAĞCAN-0001
- Conditions
- Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Postoperative, Nursing Caries
- Keywords
- Heart Surgery, pain, sternotomy, protocol, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Jun 2023 (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.
Open heart surgery method is generally used in the treatment of cardiovascular diseases. Sternotomy is the process of opening the sternum. After sternotomy, individuals experience ongoing pain in the anterior thorax. Despite developing pain methods and treatments, individuals undergoing cardiovascular surgery suffer from pain that cannot be managed well. Patients undergoing cardiac surgery experience severe pain for the first 48 hours and are in intensive care during this period. Pain is the most important stress factor for intensive care patients. The nurse and health care team should play a key role and take an active role in the management and evaluation of pain. However, there are not enough studies trying to define the role of the nurse in the management of postoperative pain. Protocols are used to provide pain management and routine pain assessment in intensive care units. The use of protocols provides maximum care to the patient, while reducing the cost. It also ensures the patient's participation in the treatment. While protocols ensure that practices are converted into evidence-based ones, they also prevent disruptions in treatment. As a result, management of the pain experiences of patients with sternotomy who underwent open heart surgery in the intensive care unit with the developed protocol; It will guide the improvement and development of pain management. It is thought that the protocol will address the pain of individuals undergoing open heart surgery in a holistic way. In addition, no study has been found in the literature that includes the development of a protocol for the pain of intensive care patients undergoing open heart surgery. For this reason, it is thought that the study will shed light on the literature by being a resource in the management and improvement of pain.
Detailed description
In this study, it is aimed to develop the open heart surgery patient care protocol and to examine its effect on the pain that develops after sternotomy. The research is planned to be carried out on the patients in the Cardiovascular Surgery Intensive Care Unit of Research Hospital. The sample size of this study was decided by power analysis. The G-Power statistics program is based on Type 1 error 0.05 and 80% power. In the power analysis of Akbayrak and Tosun's (2002) thesis study, using the results showing the average score of the satisfaction level of the patients with and without the care protocol, the sample size was determined as 17 patients for each group and 34 patients in total. However, in order to meet the parametric test assumptions, it was decided to include at least 30 people in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Heart Surgery Patient Care Protocol | Experimental | Other: Care ProtocolSpecific Practices for Pain in the Protocol * Evaluation of patients' pain in the extubated period with the Visual Anolog Scale * Active participation of the patient in pain reporting * Regular questioning of the patient's pain * Questioning pain at rest and movement * Implementing nursing interventions in painful condition (VAS≤ 4) |
| Standart Care Protocol | No intervention | –Standard care of intensive care will be given. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with sternotomy who underwent Coronary Artery Bypass Graft surgery,
- Patient with sternotomy who underwent valve surgery,
- Being 18 years or older,
- Volunteering to participate in the research,
- Being at a level to adequately answer the questions asked cognitively,
Key exclusion criteria (3 listed)
- Desiring to leave the study group during the conduct of the research,
- Delirium development in the patient during the conduct of the study,
- The patient for whom emergency surgery has been decided.
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 |
|---|---|---|
| Care ProtocolEvaluation of patients' pain in the extubated period with the Visual Anolog Scale Active participation of the patient in pain reporting Regular questioning of the patient's pain Questioning pain at rest and movement Implementing nursing interventions in painful condition (VAS≤ 4) | Other | Open Heart Surgery Patient Care Protocol |
Primary outcome
Visual Analog Scale
Time frame: 3 days
Visual Analog Scale
Scale for Evaluation of the Quality of Care Given to the Patient in Relief of Postoperative Pain
Time frame: Just before being transferred to intensive care
The scale consists of 14 items and has 3 sub-dimensions related to nursing interventions, pain management and environment. Likert type scale was used in the evaluation. 1 means "strongly disagree" and 5 means "strongly agree". The scale Cronbach's coefficient was 0.81 and the main score obtained from the scale was 45.8 ± 10.8. The scale is a reliable and valid instrument in Turkish language.
Analgesic use
Time frame: 3 days
Number of analgesic use
Type of analgesic
Time frame: 3 days
Type of analgesic
8 secondary outcomes
Anxiety
Time frame: Before going into surgery, Just before being transferred to intensive care
Blood pressure
Time frame: 3 days
respiratory
Time frame: 3 days
Fever
Time frame: 3 days
Heart rate
Time frame: 3 days
Oxygen Saturation
Time frame: 3 days
Partial pressure of carbon dioxide
Time frame: 3 days
Partial pressure of oxygen
Time frame: 3 days
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 27 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Protocol in people with Heart; Surgery, Heart, Functional Disturbance as Result and Pain, Postoperative, run by Kutahya Health Sciences 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 3 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 27 Mar 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?
Visual Analog Scale (time frame: 3 days). The study lists 4 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 27 Mar 2024.