Comparing The effect of family members' voice and nurse' voice on restlessness, anxiety, delirium and success in weaning of ventilator in patients admitted to Intensive Care Units
Comparison of the effect of family members and nurses on restlessness, anxiety, delirium and success in ventilator isolation in patients admitted to the intensive care unit of Qazvin University of Medical Sciences
Design
a prospective randomized clinical trial of three groups with a control group.
Settings and conduct
The researcher, after obtaining a license from the Ethics Committee from Qazvin University of Medical Sciences, will refer to the educational and medical centers of Qazvin University of Medical Sciences and after explaining the research and its objectives and obtaining permission from officials.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. The age of patients should be between 18-65 years (18).
2. The level of consciousness according to the Glasgow coma criterion due to trauma should be 11-8 (19).
Exclusion criteria:
1. Dissatisfaction of the patient's companions to continue participating in the study
2. A history of hearing, vision, aphasia and limb movement disorders (18,19)
Intervention groups
In one group the voice of a family member and in the other group the voice of a nurse is recorded and played by the headset to the patients and in the other group no sound is played.
Main outcome variables
restlessness,Success weanig, and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201014049029N1
Registration date:2020-11-18, 1399/08/28
Registration timing:registered_while_recruiting
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Fariba Abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 1733
Email address
faribaabdollahi93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing The effect of family members' voice and nurse' voice on restlessness, anxiety, delirium and success in weaning of ventilator in patients admitted to Intensive Care Units
Public title
Comparing The effect of family members' voice and nurse' voice on restlessness, anxiety, delirium and success in weaning of ventilator in patients admitted to Intensive Care Units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1.The age of patients should be between 18-65 years
2.The level of consciousness according to the Glasgow coma criterion due to trauma should be 11-8
3.The patient has been admitted to the ward with a diagnosis of concussion. Traumatic brain injury includes subdural, epidural, intracerebral, ventricular, and subarachnoid hemorrhages.
4.Sedation should be in the range of +2 to 2- according to Richmond criteria
5.48 hours have elapsed since hospitalization
6.Patients should have at least one healthy hearing position according to the physician or ENT consultation
7.Have no previous history of hearing loss according to family statements
8.Do not have a bandage on the ear
9.No history of depression and other mental disorders
10.Family availability and collaboration to record audio
11.Do not use alcohol and drugs with high dependence before the accident according to family statements
Exclusion criteria:
1.Dissatisfaction of the patient's companions to continue participating in the study
2.A history of hearing, vision, aphasia and limb movement disorders
3.Patients with vegetative status as determined by physician
4.Patients with severe previous head injury
5.Sudden loss of consciousness more than 3 points according to the Glasgow Coma Criterion during the intervention
6.Simultaneous participation of the patient in similar care programs such as massage therapy and the use of relaxation techniques and ...
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
All patients who meet the inclusion criteria will be included in the study by random sampling method of block division method with triple blocks. In this way, the letter A will be assigned to the test group and the letter B to the control group, and in 6 blocks with the letter A, B, C, six states ACB, ABC, CAB, BCA, BAC, CBA will be written on the sheet. The blocks will then be sorted according to a table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dept of research Qazvin University of Medical Sciences
Street address
Dept of research Qazvin University of Medical Sciences Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
City
qazvin
Province
Qazvin
Postal code
13911/34156
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
IR.QUMS.REC.1398.408
Health conditions studied
1
Description of health condition studied
Head trauma
ICD-10 code
S07.8XXS
ICD-10 code description
Crushing injury of other parts of head, sequela
Primary outcomes
1
Description
Restlessness was assessed by the Richmond Restlessness Checklist. The Richmond tool consists of 10 levels, four of which are for restlessness, one for calm and alert, and five for relaxation.
Timepoint
Before and after the intervention
Method of measurement
Richmond Restlessness Checklist
2
Description
Delirium is assessed with the Neecham Delirium instrument and this questionnaire has a total of 30 points. Based on the overall score obtained by the patient, it is divided into 4 categories; A healthy person with a score of 27-30, prone to confusion with a score of 25-26, mild delirium with a score of 20-24, moderate to severe delirium with a score of 0-19.
Timepoint
Before and after the intervention
Method of measurement
Neecham Delirium questionnaire
3
Description
Anxiety was assessed with the Facial Anxiety Scale. It has a range from 1 to 5, the lowest of which is related to the normal state of the facial state and the highest of which is the number 5 related to the maximum state of anxiety
Timepoint
Before and after the intervention
Method of measurement
Facial Anxiety Scale
4
Description
Weaning success was assessed with the Burn weaning Success Tool. The total score is 26 and after receiving a score of 17 or higher, the separation process begins.
Timepoint
Before and after the intervention
Method of measurement
Burn weaning Success Tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the voice of a family member is recorded and played to patients through a headset. This intervention is performed twice a day for six days for patients. In the intervention group, this sound will be heard by patients with 60 to 80 beats per minute with MP3 PLAYER through headphones.
Category
Other
2
Description
Intervention group: a nurse's voice is recorded and played to patients through a headset. This intervention is performed twice a day for six days for patients. In the intervention group, this sound will be heard by patients with 60 to 80 beats per minute with MP3 PLAYER through headphones.
Category
Other
3
Description
Control group: No sound is played in this group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Trauma ICUs of Qazvin University of Medical Sciences
Full name of responsible person
Fariba Abdollahi
Street address
Padegan Street, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Email
Hosrajaee@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mehdi Imam Juma
Street address
Dept of research Qazvin University of Medical Sciences Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3337 5518
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
60
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fariba Abdollahi
Position
Instructure
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 7006
Email
FaribaAbdollahi93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fariba Abdollahi
Position
Instructure
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3337 5518
Email
FaribaAbdollahi93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fariba Abdollahi
Position
Instructure
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences Shahid Beheshti, Ave' 3415613911 Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3337 5518
Email
FaribaAbdollahi93@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available