Nursing CariesNCT06193447
Early Mobilization in Cardiac Surgery
An observational study of Nursing Caries and Ambulation Difficulty, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the mobilization process and factors affecting this process in patients who underwent open heart surgery and were admitted to the cardiovascular surgery intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Ambulation Difficulty
- What is being tested?
- None intervention
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 15 Dec 2023
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Undergoing open heart surgery patients
Who may be able to join
- Being over 18 years old
- Staying in the cardiovascular intensive care unit for 24 hours or more
Who cannot join
- Being diagnosed with a psychiatric disorder
- Do not have active bleeding
- Do not have arrhythmia
- Reporting pain intensity of 4 or above on the Visual Analog Scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Early Mobilization and Affecting Factors in Patients Undergoing Open Heart Surgery: A Descriptive-Cross Sectional Study
This study was planned to determine the mobilization process and factors affecting this process in patients who underwent open heart surgery and were admitted to the cardiovascular surgery intensive care unit.
Read the detailed description
Mobilization; It is defined as "standing up, walking, being able to move and walking around, especially after the operation, when the patient stands up and walks around". Postoperative mobilization is a basic human need and one of the basic principles of nursing care. In the postoperative period, with the delay of mobilization, the patient's insulin resistance increases, muscle weakness and muscle mass loss occur, problems in pulmonary functions are experienced and the risk of thromboembolism increases.
Surgery of patients admitted to cardiovascular ICUs after open heart surgery close monitoring afterwards, maintenance of cardio-respiratory functions, healing is supported. During care in the intensive care unit Preparation of materials that may be needed by the patient, general condition of the patient and vital information monitoring symptoms, performing breathing exercises, evaluating pain and management, monitoring fluid-electrolyte balance, monitoring hemodynamic parameters, surgical wound dressing, getting the patient up as soon as possible and in bed increasing mobility. In this process, while the mobilization process of the patients is planned, the patient's The general condition and tolerance regarding mobilization should be evaluated. patient's general Depending on the suitability of the condition, turning in bed, foot-leg exercises, deep breathing and gradual mobilization, such as cough exercises, sitting in bed, standing up, and walking inform the patient and the patient's family about the methods, plan the mobilization process, The patient should be evaluated before, during and after mobilization. Early postoperative mobilization is an important component of nursing care.
Early mobilization of patients after open heart surgery, although the recommendations to increase the mobility are getting stronger, the mobilization levels of the patients are still not at the desired level. Although studies examining the early mobilization process of patients after open heart surgery have been conducted so far, findings regarding the clinical factors affecting this process are very limited.
- Conditions
- Nursing Caries, Ambulation Difficulty
- Being tested
- None intervention
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None interventionOther
None intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mobilization level
Assessed with Intensive Care Units-Mobility Scale. The scale used to evaluate patient mobiility level on postoperative days. It consisted of 11 items with scoring, classification and explanation from 0 (zero) to 10 (ten), ranging from lying in bed/passive exercises to independent ambulation.
Measured: Postoperative day 2
Pulse rate changes between before and after mobility
Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.
Measured: Twice: Before mobilization and after mobilization (5 minutes later)
Blood pressure (both of systolic and diastolic blood pressure) changes between before and after mobility
Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.
Measured: Twice: Before mobilization and after mobilization (5 minutes later)
Oxygen saturation changes between before and after mobility
Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.
Measured: Twice: Before mobilization and after mobilization (5 minutes later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start2 Jan 2023
- Primary completion15 Sep 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Arslan, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193447
- Sponsor's protocol ID
- Cardiac surgery
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Early Mobilization and Affecting Factors in Patients Undergoing Open Heart Surgery: A Descriptive-Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06193447
- Acronym / sponsor ID
- Cardiac surgery
- Conditions
- Nursing Caries, Ambulation Difficulty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 5 Jan 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 study was planned to determine the mobilization process and factors affecting this process in patients who underwent open heart surgery and were admitted to the cardiovascular surgery intensive care unit.
Detailed description
Mobilization; It is defined as "standing up, walking, being able to move and walking around, especially after the operation, when the patient stands up and walks around". Postoperative mobilization is a basic human need and one of the basic principles of nursing care. In the postoperative period, with the delay of mobilization, the patient's insulin resistance increases, muscle weakness and muscle mass loss occur, problems in pulmonary functions are experienced and the risk of thromboembolism increases.
Surgery of patients admitted to cardiovascular ICUs after open heart surgery close monitoring afterwards, maintenance of cardio-respiratory functions, healing is supported. During care in the intensive care unit Preparation of materials that may be needed by the patient, general condition of the patient and vital information monitoring symptoms, performing breathing exercises, evaluating pain and management, monitoring fluid-electrolyte balance, monitoring hemodynamic parameters, surgical wound dressing, getting the patient up as soon as possible and in bed increasing mobility. In this process, while the mobilization process of the patients is planned, the patient's The general condition and tolerance regarding mobilization should be evaluated. patient's general Depending on the suitability of the condition, turning in bed, foot-leg exercises, deep breathing and gradual mobilization, such as cough exercises, sitting in bed, standing up, and walking inform the patient and the patient's family about the methods, plan the mobilization process, The patient should be evaluated before, during and after mobilization. Early postoperative mobilization is an important component of nursing care.
Early mobilization of patients after open heart surgery, although the recommendations to increase the mobility are getting stronger, the mobilization levels of the patients are still not at the desired level. Although studies examining the early mobilization process of patients after open heart surgery have been conducted so far, findings regarding the clinical factors affecting this process are very limited.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Undergoing open heart surgery patients
Key inclusion criteria (2 listed)
- Being over 18 years old
- Staying in the cardiovascular intensive care unit for 24 hours or more
Key exclusion criteria (4 listed)
- Being diagnosed with a psychiatric disorder
- Do not have active bleeding
- Do not have arrhythmia
- Reporting pain intensity of 4 or above on the Visual Analog Scale
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 |
|---|---|---|
| None interventionNone intervention | Other | – |
Primary outcome
Postoperative mobilization level
Time frame: Postoperative day 2
Assessed with Intensive Care Units-Mobility Scale. The scale used to evaluate patient mobiility level on postoperative days. It consisted of 11 items with scoring, classification and explanation from 0 (zero) to 10 (ten), ranging from lying in bed/passive exercises to independent ambulation.
Pulse rate changes between before and after mobility
Time frame: Twice: Before mobilization and after mobilization (5 minutes later)
Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.
Blood pressure (both of systolic and diastolic blood pressure) changes between before and after mobility
Time frame: Twice: Before mobilization and after mobilization (5 minutes later)
Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.
Oxygen saturation changes between before and after mobility
Time frame: Twice: Before mobilization and after mobilization (5 minutes later)
Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.
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 8 Jan 2024.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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?
An observational study of Nursing Caries and Ambulation Difficulty, run by Aydin Adnan Menderes 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 2 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 8 Jan 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?
Postoperative mobilization level (time frame: Postoperative day 2). 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 8 Jan 2024.