The effect of familiar voice on the patient and the use of sedatives in patients with mechanicalventilation in the ICU trauma wards of the Madani hospital
Determining the effect of family members' voices on anxiety and the use of sedatives in patients admitted to the intensive care unit
Design
This clinical trial has a control group with two parallel, double-blind randomized intervention groups. There is no precedent for the study phase and no drug combination is tested. This study will be conducted on 99 patients, which was used for randomization using the method of dividing blocks with 6 blocks.In each group, 33 samples and a total of 99 samples will be included in the study.
Settings and conduct
This study will be done in the ICU department.
At first, based on random assignment, patients are divided into 3 groups (2 intervention groups, one control group). The person who performs the intervention for the patient and the person who registers the patient's information is also blind. In the two intervention groups, auditory stimulation is done twice a day for 15-30 minutes during two weeks. one group with the voice of the nurse and the other with the voice of family members).
Participants/Inclusion and exclusion criteria
Concussion patients admitted to the ward with any cerebral hemorrhage, including
Subdural, epidural, intracerebral, ventricles, and subarachnoid bleeding.
Patients with a level of consciousness of 8-11 (according to the Glasgow Coma Scale) and 10-16 according to the Fore criterion
Intervention groups
Intervention group one: recipient of a familiar voice (first degree relatives of the patient are asked to repeat the message written by the researcher and their voice is recorded)
In the second intervention group, the nurse records a message and plays it to the patient.
Main outcome variables
The level of anxiety - the level of use of sedatives
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220924056030N1
Registration date:2022-11-18, 1401/08/27
Registration timing:prospective
Last update:2022-11-18, 1401/08/27
Update count:0
Registration date
2022-11-18, 1401/08/27
Registrant information
Name
iran tayebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
tayebi.medical@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of familiar voice on the patient and the use of sedatives in patients with mechanicalventilation in the ICU trauma wards of the Madani hospital
Public title
Investigating the effect of sound on reducing the anxiety level of patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the patient is 18 to 65 years
The level of consciousness should be 8 to 11 according to the Glasgow Trauma Coma Scale, and 10 to 16 according to the Faure Scale.
The patient has been admitted to the ward with a diagnosis of concussion. Concussion includes subdural, epidural, intracerebral, ventricular, and subarachnoid hemorrhages.
Sedation should be in the range of +2 to -2 based on the Richmond criteria.
48 hours have passed since hospitalization
According to the opinion of the attending physician or ENT consultation, patients should have healthy hearing on at least one side.
Don't have bandages in their ears
No history of depression and other mental disorders
Family availability and cooperation for audio recording
Not using tobacco, alcohol and highly addictive drugs before the accident according to the family's statement
Exclusion criteria:
Having an underlying disease
Have a previous history of hearing loss according to family statements
Any illness except head injury
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
For the purpose of random allocation, the method of dividing blocks of six is used. In this way, two test groups of letter A and B were assigned a control group of letter C,And in blocks of six with letters A, B, and C, ninety states such as ABABCC, AABBCC were written on sheets and thrown into a containerRandomly one of these sheets was taken out of the container and the composition written on it was written down and that sheet was placed outside the container, The sample size in this study was estimated to be 99 patients; Therefore, this process was repeated 17 times (102 x 6 = 17) and each time the extracted combination was written on the sheet following the previous combination. Then, each letter from the beginning of the blocks was assigned a number from 1 to 102.Then the letter was put inside the envelope and the number of that letter was written on the envelope. Each time a patient was admitted, one of the envelopes was opened in the order of the numbers written on the envelope, and it was determined whether the patient should be in the test group or the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person performing the intervention for the patient as well as the person recording the patient's information are blinded to which study patient is in which study group (intervention 1 or 2 and control).
Placebo
Not used
Assignment
Parallel
Other design features
non
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
The level of anxiety: an emotional state that is associated with a feeling of tension, anger, changes in vital signs and increased need for oxygen and increased mortality in patients.س
Timepoint
After the audio is played, it is recorded daily
Method of measurement
Anxiety facial scale
2
Description
Dosage of drugs taken in mg during the day of hospitalization
Timepoint
Daily
Method of measurement
According to the amount of daily prescription and the amount of medicine received through case review and nursing report
3
Description
The type of sedative drugs, which are divided into 4 categories: barbiturates, benzodiazepines, and narcotics.
Timepoint
Daily
Method of measurement
According to the order prescribed through the patient file and nursing report
4
Description
Duration of taking sedatives
Timepoint
Daily
Method of measurement
Daily
5
Description
Mechanical ventilation status
Timepoint
Daily
Method of measurement
View and insert in the checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group that receives a familiar voice,First-degree relatives are asked who had a stronger emotional relationship with the patient, then the person who had a stronger emotional relationship according to the patient's relatives is asked to repeat the message written by the researcher and their voice is recorded. Yes, this sound is played twice a day for 15 to 30 minutes.
Category
Other
2
Description
Intervention group: The second group is the group that receives the nurse's voice so that the nurse repeats the message that the researcher says and this message is recorded, the recorded message every day and every time for 15 to 30 minutes during two weeks. It is distributed to patients.
Category
Other
3
Description
Control group: Patients in the control group have headphones placed on their ears for 15-30 minutes, but no sound is played for them (putting headphones without sound on the ears to reduce the volume of sounds and not hear false sounds by the patient)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Madany Hospital
Full name of responsible person
Zahra Tayebi Myaneh
Street address
Mahan Blvd. Taleghani st. Alborz
City
Alborz
Province
Alborz
Postal code
0000000000
Phone
+98 26 3442 7001
Fax
+98 26 3442 7001
Email
Tayebi.medical@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Faculty of Nursing, Alborz University of Medical Sciences