The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU

Istanbul University - Cerrahpasa (IUC)

Status: Completed

Conditions: Critical Care; Sleep Quality; Early Mobilization; Nursing Caries

Treatments: Other: Early Mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT06344468

531393

Details and patient eligibility

About

The goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU).

The hypothesis are:

Hypothesis I: Early mobilization positively affects the sleep quality of patients.

Hypothesis II: Early mobilization positively affects the physiological parameters of patients (respiratory rate, heart rate, blood pressure, body temperature, pain).

Hypothesis III: Early mobilization shortens the length of stay of patients in the intensive care unit (ICU).

Early mobilization will begin in the experimental group after sedation is discontinued within the first 12 hours and its effects disappear. In early mobilization, in the evaluation of in-bed mobilization, physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Surgical wounds and dressing areas, if any, are protected, drains are identified, care is taken not to remove equipment such as urinary catheters or nasogastric tubes, when the patient is seated on the edge of the bed with the help of a nurse, when he/she is stood up next to the bed with the support of the nurse, when he/she is made to sit in a chair next to the bed and when he/she is in a chair. While sitting, 1st minute, 5th minute, 10th minute respiratory rate, sPO2, heart rate, blood pressure, body temperature values and pain levels will be recorded and these data will be evaluated on their own. During mobilization, if the patient develops chest pain, arrhythmia, hypertension (systolic pressure>160 mmHg), or hypotension (systolic pressure<90 mmHg), tachypnea, or hypoxia, a break will be taken and the physician will be consulted. The same procedures will be repeated during the mobilization of the patient in the first 24-36 hours and the necessary records will be made by the researcher.

Control Group:

After admission to the Cardiovascular Surgery ICU, the type, purpose and implementation process of the study will be explained to the patients, and a routine/standard postoperative mobilization procedure will be applied to the patients in the control group. Accordingly, patients will be mobilized in the first 24 hours after surgery, and in the evaluation of in-bed mobilization, their physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Again, arterial blood gas monitoring of the patients in the control group will be performed at maximum 4-hour intervals, and respiratory parameters will be frequently evaluated and recorded.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be 18 years of age or older,
• Have been in the ICU for at least 36 hours,
• Be independent in their mobility activities,
• Maintain respiratory activity without being dependent on a device/equipment,
• Have a Glasgow Coma Scale score of at least 15,
• Have sedation discontinued within the first 6 hours.

Exclusion criteria

• Be fully sedated,
• Have neurological or orthopedic conditions that could create contraindications (such as cerebrovascular events, circulatory disorders, pulmonary embolism),
• Be unable to tolerate mobilization (severe bradycardia, arrhythmia, chest pain, hypotension, hypertension, tachypnea, SaO2 <90%, etc.),
• Have a Glasgow Coma Scale score below 15,
• Be dependent on mobility activities before surgery,
• Use sleep medication and experience sleep problems before surgery,
• Have extubation not performed within the first 24 hours after surgery.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Early mobilization began after discontinuation of sedation and resolution of its effects within the first 12 hours. During early mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were evaluated and recorded in the supine and semi-fowler positions for in-bed mobilization assessment. For out-of-bed mobilization, physiological parameters were determined and recorded while the patient was in a sitting position, with the head elevated at 45° before mobilization. With the assistance of a nurse, the patient was guided to sit on the edge of the bed, stand up with support, sit on a chair next to the bed, and record respiratory rate, SpO2, heart rate, blood pressure, body temperature, and pain levels at 1, 5, and 10 minutes while sitting on the chair. Similar procedures were repeated during patient mobilization at 24 and 36 hours.

Treatment:

Other: Early Mobilization

Control Group

No Intervention group

Description:

They underwent routine/standard postoperative mobilization procedures. Accordingly, patients were mobilized within the first 24 hours post-surgery, and during in-bed mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were evaluated in the supine and semi-fowler positions.During out-of-bed mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were determined. Respiratory parameters were frequently evaluated at intervals of up to 4 hours using arterial blood gas analysis. The patient was assisted by a nurse to sit on the edge of the bed, stand up with support, sit on a chair next to the bed, and record respiratory rate, SpO2, heart rate, blood pressure, body temperature, and pain levels at 1, 5, and 10 minutes while sitting on the chair. These data were then evaluated internally. Similar procedures were repeated during patient mobilization at 24 and 36 hours.