Investigating the effect of back massage on pain and hemodynamic variables of patients hospitalized in the intensive care unit.

Determining the effect of back massage on pain and hemodynamic symptoms of in patients in the intensive care unit

Phase III Clinical Trial with Control Group, single-blinded, blocked randomization, on 60 patients

The population included patients hospitalized in the intensive care unit of four educational hospitals affiliated to Kermanshah University of Medical Sciences (Emam Reza, Imam Khomeini, Ayatollah Taleghani, and Farabi hospitals). Before the intervention, the pain variable is measured using the Critical-Care Pain Observation Tool, and blood pressure, heart rate, respiratory rate, and oxygen saturation level are measured using a monitor. Intervention is performed for one time for 15 minutes and at the end pain variable and hemodynamic variables are measured again. This study will be single-blind, and the statistical analyst and the researcher who performs random allocation are blind.

Inclusion criteria: 1. Consent of the Patient's legal Guardian for Cooperation 2. Patients with Glasgow Coma Scale (GCS) less than 8 3. Hospitalization History of more than 48 Hours in the Intensive Care Unit 4. Age between 18 and 70 Years Exclusion criteria: 1. Prohibition of Changing Body Position for the Patient 2. Severe Head Injury 3. Skin Wounds in the Massage Area 4. Previous Operations in the Back, lung and Abdomen

In the intervention group, each back massage session includes a combination of Effleurage, Petrissage, Friction, and Tapotement techniques for 15 minutes (between 16:00 and 18:00) in the lumbar region, back, shoulder blades, shoulders and it is applied to the neck area. There is no intervention in the control group.

The primary outcome of the plan is changes in pain, and changes in pain intensity can cause changes in hemodynamic variables as a secondary outcome.

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.

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.