Determining the effect of inhibiting visual and auditory stimuli during night sleep on the amount of analgesic medication required

Determining the effect of inhibiting visual and auditory stimuli during night sleep on the amount of analgesic medication required during waking hours in patients admitted to the Intensive Care Unit of burn.

Clinical trial, parallel groups, double-blind, randomized, phase 3 on 30 patients. In order to randomize, the block randomization method will be used. In order to randomize, a random number table will be used.

In this research, all patients hospitalized in the Intensive Care Unit of burn, with sleep disorders, in Shahid Motahari Hospital, Tehran, will be included in the study. Patients will be randomly divided into 2 groups based on blocks of 6. The sample size for each study group is 15 people. A total of 30 patients will be examined. Data collection and data analysis will be blinded.

Burn percentage between 30 and 60%, consciousness, Age between 15-55 years Having a sleep disorder The minimum stay of the patient in the intensive care unit is expected to be eight days and nights Vision or hearing impairment, history of addiction, mental disorder, sleep apnea, head and face burns, phobia of the dark

Intervention group: During the 48 hours of examining the patients, during night sleep from 22:00 to 6:00, light and sound stimuli will be controlled with the help of ear muffs and blindfolds. Control group: During the 48 hours of examination, the patients will sleep at night without the control of sound and light stimuli, from 22:00 to 6:00. The next day, the amount of prescribed narcotics and non-opioid painkillers, the intensity of the patient's pain from 0: no pain to 10: the most severe pain he has ever experienced will be recorded.

Pain

Patients will be randomly divided into 2 groups. The randomization tool will randomize the table of numbers. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 6 blocks will be formed and in each block 3 people from intervention group and 3 people will be placed in the control group. A total of 5 blocks will be considered to reach the sample size. Blocks contain numbers, numbers represent study groups. Their order will be determined by the statistician from the beginning. In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. became. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.

Patients will be aware that they will be randomly assigned to one of the two study groups, and they will also be aware of the group they will be placed in. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the information based on groups 1 and 2 and will not know the type of drug injected in the groups and will be kept blind.