Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-10-01
2023-12-29
Brief Summary
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Design: A single-center, parallel-group, randomized controlled trial. Methods: The study was conducted with 60 patients in 2023. The intervention group received a Safe Early Mobilization Protocol including bedside elevation, deep breathing and coughing exercises, sitting upright in bed, sitting on the edge of the bed, standing, ambulation, and sitting in a bedside chair from the day of surgery until the fourth postoperative day. The control group received routine mobilization care. Respiratory parameters, orthostatic hypotension (OH), orthostatic intolerance (OI), mobilization distance, anxiety level, and hospital stay were evaluated.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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SEMP
A safe early mobilization protocol developed by the researchers was applied.
The safe early mobilization protocol
This protocol was developed to guide the early postoperative mobilization of patients undergoing coronary artery bypass graft surgery, covering the period from the day of surgery to the fourth postoperative day. Prior to mobilization, patients are evaluated using a checklist ensuring physical and environmental safety. On the day of surgery, following extubation by the responsible physician, six stages are applied: bed head elevation, deep breathing exercises, incentive spirometry, passive range of motion (ROM) exercises, sitting upright (90°), and sitting on the edge of the bed. On postoperative days 1-3, standing at the bedside, ambulation, and sitting on a chair are added. Target walking distances are 100-150 m on day 1, 200-250 m on day 2, and 300-350 m on day 3. Distances are measured by the researcher using a meter. The protocol concludes on the 4th postoperative day when the patient can ambulate independently.
Control group
The routine protocol used in the hospital was applied.
Control Group
Patients in the control group were informed about the current mobilization practices applied in the clinic before surgery. The morning after the surgery (the first day after the surgery), the patient is first seated in the bed, and in the second stage, he is made to sit on the edge of the bed with his feet touching the floor and is observed. In the third stage, the patient stands in an upright position and if there is no dizziness or blackout, the patient is seated on a chair next to the bed. The duration of sitting in the chair is determined depending on the general condition of the patient (pain, dizziness, blackout, nausea). On the 2nd and 3rd postoperative day, patients were contacted by nurses and care support staff while they had a chest tube; Then, the patient is mobilized only with his/her relative. There is no standard practice regarding how long patients should be mobilized during the day.
Interventions
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The safe early mobilization protocol
This protocol was developed to guide the early postoperative mobilization of patients undergoing coronary artery bypass graft surgery, covering the period from the day of surgery to the fourth postoperative day. Prior to mobilization, patients are evaluated using a checklist ensuring physical and environmental safety. On the day of surgery, following extubation by the responsible physician, six stages are applied: bed head elevation, deep breathing exercises, incentive spirometry, passive range of motion (ROM) exercises, sitting upright (90°), and sitting on the edge of the bed. On postoperative days 1-3, standing at the bedside, ambulation, and sitting on a chair are added. Target walking distances are 100-150 m on day 1, 200-250 m on day 2, and 300-350 m on day 3. Distances are measured by the researcher using a meter. The protocol concludes on the 4th postoperative day when the patient can ambulate independently.
Control Group
Patients in the control group were informed about the current mobilization practices applied in the clinic before surgery. The morning after the surgery (the first day after the surgery), the patient is first seated in the bed, and in the second stage, he is made to sit on the edge of the bed with his feet touching the floor and is observed. In the third stage, the patient stands in an upright position and if there is no dizziness or blackout, the patient is seated on a chair next to the bed. The duration of sitting in the chair is determined depending on the general condition of the patient (pain, dizziness, blackout, nausea). On the 2nd and 3rd postoperative day, patients were contacted by nurses and care support staff while they had a chest tube; Then, the patient is mobilized only with his/her relative. There is no standard practice regarding how long patients should be mobilized during the day.
Eligibility Criteria
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Inclusion Criteria
Resting heart rate \<110/min
Mean arterial pressure between 60-110 mmHg
Oxygen saturation (SpO₂) \>88%
Receiving dopamine infusion ≤5 mcg/kg/min at the time of enrollment
No auditory, speech, or visual impairments
No neurological contraindications (e.g., cerebrovascular accident \[CVA\], ataxia, multiple sclerosis \[MS\])
No orthopedic contraindications that prevent mobilization (e.g., fractures or sequelae)
Provided informed consent to participate in the study
Age ≥18 years
Able to speak Turkish
Literate patients
Exclusion Criteria
Postoperative cerebrovascular events
High-dose inotropic drug infusion in the early postoperative period:
Dopamine ≥10 mcg/kg/min
Norepinephrine ≥0.5 mcg/kg/min
Concurrent dopamine and norepinephrine infusion
Severe arrhythmias preventing mobilization, including:
Sinus tachycardia ≥120/min
Rapid atrial fibrillation
Ventricular tachycardia
Ventricular fibrillation
Advanced chronic obstructive pulmonary disease (COPD) or bronchiectasis
Diagnosed anxiety disorders
18 Years
ALL
Yes
Sponsors
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Hulya BULUT
OTHER
Lokman Hekim University
OTHER_GOV
Ankara Guven Hospital
UNKNOWN
Responsible Party
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Hulya BULUT
Prof. Dr.
Locations
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Guven Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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36970
Identifier Type: -
Identifier Source: org_study_id
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