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IRCT20231010059680N1 IRCT 2023-12-19 Kermanshah University of Medical Sciences Investigating the effect of back massage on pain and hemodynamic variables of patients hospitalized in the intensive care unit Investigating the effect of back massage on pain and hemodynamic variables of patients hospitalized in the intensive care unit. 2023-12-16 anticipated 60 Complete https://irct.ir/trial/73230 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, the required number is selected from among the people who meet the inclusion criteria, and then these selected people are assigned to each of the intervention and control groups. The best method of allocating the studied subjects to each of the intervention and control groups is random allocation which can be implemented in different ways. The first step towards implementing a random process is creating random sequences. In this study, the creation of random sequences is done by a finite randomization method called block randomization to balance the number of samples allocated to each of the studied groups. This method consists of a large block for the total sample size in which the block is selected by selecting blocks with the size of each block of four (2 participants in the intervention group and 2 participants in the control group) and each of the six possible states of the number for the block of four is assigned as follows: 1) AABB 2) ABAB 3) ABBA 4) BBAA 5) BABA 6) BAAB Using the random table of numbers, the numbers between 1 and 6 are selected and according to each number of the allocation list, intervention or control group will be determined. Sampling will continue until the samples are completed. The second step after random sequence creation is sequence closing, which is called random allocation closing. In this study, the central randomization method is used. In this method, random sequencing is available to a specific person or center, and sampling is done in one or more centers simultaneously. The researcher communicates with the relevant center based on the order of the participants entering the study and asks about the random allocation of the participants to the specific group. The method of communication includes the use of telephone, SMS, email, etc. One of the applications of this method is in multi-center studies. The third step is the random allocation process, which should separate the person responsible for the random program from other researchers (except the person involved in the registration stage of the participants or the assignment of participants to study groups) to minimize the selection bias as much as possible, Blinding description: One of the goals of blinding will be to reduce implementation bias and analysis bias. For this reason, the questionnaires will be completed before assigning the participants to the intervention and control groups, using sealed envelopes (blinding the participants) and presenting the intervention at a time other than the time of presenting the routine programs and presenting the questionnaire to the intervention group. It will be on a day other than the day of presentation to the control group. After the intervention, the people who collected the questionnaires and entered the data were not aware of the group of people, and the data analyst was not from the group of people providing the intervention (blinding of information and analysis). This study will be single blind. This means that the patients are aware of the type of intervention, but the statistical analyst and the researcher who performs the random assignment are blind. N/A The effect of back massage on pain and hemodynamic symptoms of in patients in the intensive care unit. Intervention 1: Intervention group: All patients who meet the inclusion criteria in the intervention group are placed in the right-side lying position because gas exchange and pulmonary perfusion are better in this position. According to the study protocol of Yilmaz et al (2020), before the massage, the patients and their environment are prepared, and privacy is ensured. A drop of liquid Vaseline smears at room temperature. Liquid Vaseline is used to lubricate the skin and reduce friction. Each back massage session includes a combination of Effleurage, Petrissage, Friction, and Tapotement techniques. The back massage begins with the exfoliation movement (gliding), and then we lift and knead the skin, subcutaneous tissue, and muscles with our fingers (Petrissage). In the next step, using fingers and thumb, we take the subcutaneous tissue and muscle and move from the hip area to the shoulder. Then, in the area of ​​the cervical spine, we apply gentle pressure around each vertebra with small circular movements (Friction), then use the outer edge of the hand to rhythmically hit the soft tissue structures (Tapotement). The massage continues for 15 minutes and ends with the Effleurage technique. Back massage is applied to the lumbar region, back, shoulder blades, shoulders, and neck area. In the intervention group, before the intervention, the pain is measured using the Critical Care Pain Observation Tool (CPOT) for measuring the pain of special care patients, and blood pressure, heart rate, breathing rate, and oxygen saturation level are measured using the monitor system of each patient. The intervention is performed once (between 16:00 and 18:00) for 15 minutes, and at the end, two variables of pain and hemodynamic variables are measured again. Intervention 2: Control group: In the control group, the pain variable is measured using the Critical Care Pain Observation Tool (CPOT), and the blood pressure, heart rate, breathing rate, and oxygen saturation level are measured using the monitor system of each patient, and 15 minutes later without No re-intervention, all variables are measured and recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Sara Ashrafabadi
Aghaghia Complex, 203 Alley,Al Agha Boulvard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714666917 +98 83 3836 1677 sara.ashrafabadi@kums.ac.ir Kermanshah University of Medical Sciences scientific Sara Ashrafabadi
Aghaghia Complex, 203 Alley,Al Agha Boulvard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714666917 +98 83 3836 1677 sara.ashrafabadi@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Consent of the Patient's legal Guardian for Cooperation Patients with Glasgow Coma Scale (GCS) less than 8 Hospitalization History of more than 48 Hours in the Intensive Care Unit Age between 18 and 70 Years 18 years 70 years Both Prohibition of Changing Body Position for the Patient Severe Head Injury Skin Wounds in the Massage Area Previous Operations in the Back, lung and Abdomen Rehabilitation N/A Intervention group: All patients who meet the inclusion criteria in the intervention group are placed in the right-side lying position because gas exchange and pulmonary perfusion are better in this position. According to the study protocol of Yilmaz et al (2020), before the massage, the patients and their environment are prepared, and privacy is ensured. A drop of liquid Vaseline smears at room temperature. Liquid Vaseline is used to lubricate the skin and reduce friction. Each back massage session includes a combination of Effleurage, Petrissage, Friction, and Tapotement techniques. The back massage begins with the exfoliation movement (gliding), and then we lift and knead the skin, subcutaneous tissue, and muscles with our fingers (Petrissage). In the next step, using fingers and thumb, we take the subcutaneous tissue and muscle and move from the hip area to the shoulder. Then, in the area of ​​the cervical spine, we apply gentle pressure around each vertebra with small circular movements (Friction), then use the outer edge of the hand to rhythmically hit the soft tissue structures (Tapotement). The massage continues for 15 minutes and ends with the Effleurage technique. Back massage is applied to the lumbar region, back, shoulder blades, shoulders, and neck area. In the intervention group, before the intervention, the pain is measured using the Critical Care Pain Observation Tool (CPOT) for measuring the pain of special care patients, and blood pressure, heart rate, breathing rate, and oxygen saturation level are measured using the monitor system of each patient. The intervention is performed once (between 16:00 and 18:00) for 15 minutes, and at the end, two variables of pain and hemodynamic variables are measured again. Control group: In the control group, the pain variable is measured using the Critical Care Pain Observation Tool (CPOT), and the blood pressure, heart rate, breathing rate, and oxygen saturation level are measured using the monitor system of each patient, and 15 minutes later without No re-intervention, all variables are measured and recorded. Pain score in Critical Care Pain Observation Tool. Timepoint: Immediately after the end of the intervention. Method of measurement: Critical Care Pain Observation Tool is a tool used to measure pain in patients who are unable to verbally describe their pain. This tool consists of four parts. 1- facial expression, 2- body movements, 3- muscle stiffness, and 4- patient adaptation to ventilator in intubated patients. Each step is scored between 0 and 2 points according to the patient's condition. The maximum score is eight, which indicates excessive pain, and the absence of pain is scored as zero. Changes in blood pressure. Timepoint: Immediately after the end of the intervention. Method of measurement: Patient vital signs monitor device. Change in heart rate. Timepoint: Immediately after the end of the intervention. Method of measurement: Patient vital signs monitor device. Change in respiratory rate. Timepoint: Immediately after the end of the intervention. Method of measurement: Patient vital signs monitor device. Change in oxygen saturation level. Timepoint: Immediately after the end of the intervention. Method of measurement: Patient vital signs monitor device. Kermanshah University of Medical Sciences Approved 2023-10-10 Ethics committee of Kermanshah University of Medical Sciences University of Medical Science, Office Building No. 2, Hafezieh District, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)