Determining the effect of verbal communication on the level of consciousness, pain and agitation in patients admitted to Intensive Care Unit in Ali-Ebne Abitaleb Hospital in Rafsanjan City in 2019
Design
Two arm parallel-group randomized trial with blinded intensive care and outcome assessment. Patients' level of consciousness, pain, and restlessness will be measured in 35 patients in the intervention group and 35 patients in the control group.
Settings and conduct
This study is a randomized, double blind clinical trial performed on patients admitted to intensive care units of Ali-Ebne Abitaleb Hospital in Rafsanjan. Patients in the intervention group will receive verbal communication twice a day for 14 days. The control group will under routine care. In the intervention group, the patient's level of consciousness is measured by Glasgow Coma Scale (GCS) for level of consciousness, Behavioral Scale for Pain (BPS criteria) and restlessness with the Rass criterion before and 15 minutes after verbal communication by someone other than the researcher. In this study, patients beacuse of low conscious and evaluator did not know about control group or intervention group
Participants/Inclusion and exclusion criteria
Age 15-75 years
GCS≤ 8
Traumatic and non-traumatic patients
No previous history of brain injury
No history of hearing impairment, or hearing loss
stabilizing vital signs in patient in the intensive care unit
Intervention groups
Intervention group: Patients in the intervention group receive verbal communication twice a day for one week.
Control group: receive routine care.
Main outcome variables
level of consciousness, pain and restlessness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N22
Registration date:2020-05-08, 1399/02/19
Registration timing:registered_while_recruiting
Last update:2020-05-08, 1399/02/19
Update count:0
Registration date
2020-05-08, 1399/02/19
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-28, 1398/11/08
Expected recruitment end date
2021-01-27, 1399/11/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of verbal communication on the level of consciousness, pain and agitation in patients admitted to Intensive Care Unit
Public title
The effect of verbal communication on the level of consciousness, pain and agitation in patients admitted to Intensive Care Unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15-75 years
GCS≤ 8 scale score
Traumatic and non-traumatic patients
No history of previous brain injury
No history of the previous disorder or loss hearing
Stabilizing the patient's vital signs in the intensive care unit
Exclusion criteria:
Cranial fractures in the temporal region according to the report CT-Scan
Bleeding in this temporal area according to a report CT-Scan
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
according to the random block method, Persons will be divided into two groups of 35 patients، intervention group and control group. Patients were randomly assigned to 7- 10 person blocks and then the blocks will be divided into two groups and divided into groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researcher colleague do not aware of the type of group. Patients do not aware of their type of group because of decreased level of consciousness. The researcher colleague who measure level of consciousness, pain and restlessness in both groups do not aware whether the Patient receive verbal communication (intervention group) or not (control group).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Emam Ali Blv, Central Organization of the Central Organization of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Approval date
2019-03-28, 1398/01/08
Ethics committee reference number
IR.RUMS.REC.1398.189
Health conditions studied
1
Description of health condition studied
consciousness
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
3
Description of health condition studied
Restlessness
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
level of consciousness
Timepoint
Before and fifteen minutes after intrvention
Method of measurement
Glasgow Coma Scale (GCS)
2
Description
pain
Timepoint
Before and fifteen minutes after intrvention
Method of measurement
Behavioral Pain scale
3
Description
restless
Timepoint
Before and fifteen minutes after intrvention
Method of measurement
Richmond Agitation-Sedation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Verbal communication is based on the nurse's relationship with the patient, including the nurse's introduction, Inform the patient about the present situation, time and place, Introducing a physician or physicians, a brief description of what has happened to the patient, a brief account of what happened to the patient, the reason for being admitted to ICU, expressing the patient's peripheral status, actions were taken by the patient to expedite the recovery process, describing the patient's current condition, statement of actions to be taken in the next shift or days following the patient, instilling hope and striving for recovery, If necessary, ask patient to cooperate with treatment team, tolerate specific devices Ventilator wrap, brief description of ICU, and patient coordination with therapies and treatment modalities, how to communicate with nurses, and symptoms of recovery, the purpose of medical and nursing care, and measures to improve early and return the patient to the family. The intervention group will have verbal communication for at least 15-20 minutes for one week and twice daily (evening and night shift). Verbal communication will be made with the voice of a trained ICU nurse.
Category
Treatment - Other
2
Description
Control group: In the control group, do not any intervention. routine care is performed
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebne Abitaleb Hospital in Rafsanjan City
Full name of responsible person
Fatemeh Mohammad Akbari
Street address
Emam Ali Blv, Ali-Ebne Abitaleb Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 3611
Email
FMohammadAkbari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Shamsizade
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ravari
Position
Nursing PH.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ravari
Position
Nursing PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam Ali Bulvarde-central institute
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Mirzaei
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam Ali Blvd., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Email
t.mirzaei@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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