Determination the effect of visiting based on Developed Protocol on Physiological Parameters and Delirium of Patients Admitted to Intensive Care Unit
Design
This study is a single- blind clinical trial. The research population is patients admitted to internal intensive care units of public hospitals of Mashhad who are over 18 years of age and have a full knowledge of Persian language, relative alertness and ability to communicate verbally or non verbally. Sampling will be done through available sampling and the first sample will be placed randomly in the test or control group. Sampling for the other group will not be performed until the patients in the first selection group are present, and after the discharge of these patients, sampling will be done for the next group. This will continue to complete the sampling for the two groups. In the control group the visinting will be done in the routin way in intensive care unit. In the test group, the visiting will be done in accordance with the protocol. This protocol includes the appointment of a visitor, training him on how to meet and control the correct conduct of the visit. Physiological parameters include systolic and diastolic blood pressure, heart rate, respiratory rate and hemoglobin saturation from oxygen before, during and immediately after each visit, and delirium using the "Confounding Scale of Nellon and Champaigne" at the beginning of the study and in the first, second and third days after starting the study, will be completed for patients in both groups. Finally, data will be analyzed using the statistical software.
Settings and conduct
A clinical trial study will be carried out blindly in Imam Reza Hospital in Mashhad, so that the Delirium evaluator will not be aware of the allocation of patients to the control or intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
The patients should be satisfied to participate in the study.
They should be hospitalized in ICU.
They should have the ability to communicate verbally or non-verbally.
Their age should be 18-70 years.
Hemodynamic stability at least 30 minutes prior to the measurment related to the study
Not getting known mental illness
GCS score is between 11 and 15
Exclusion criteria:
Unwillingness to continue participating in the study.
The lack of collaboration of the family of patients.
Starting the drugs that affect on the measures of the criteria at the beginning and during the study period
Intervention groups
The intervention group are patients hospitalized in Imam Reza Hospital, Mashhad, Iran that visiting will be conducted in accordance with the protocol. The control group also includes patients similar to the intervention group that visiting will done in routine.
Main outcome variables
Physiological Indices and Arterial Oxygen Saturation and Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161229031654N2
Registration date:2018-01-25, 1396/11/05
Registration timing:registered_while_recruiting
Last update:2018-01-25, 1396/11/05
Update count:1
Registration date
2018-01-25, 1396/11/05
Registrant information
Name
zahra nazari ostad
Name of organization / entity
masshad university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 51 3276 5809
Email address
nazariz1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research os masshad university of medical sience
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment the effect of visiting based on developed protocol on physiologic parameters and delirium in patient hospitslized in ICU
Public title
Effect of visiting based on designed protocol on physiologic parameters and delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Ability to communicate verbally or non-verbally
Age of 18-70
Hemodynamic stability at the start of the study
Not getting known mental illness
The patient's GCS score 11 to 15
Familiarities with Persian language
Exclusion criteria:
Unwillingness to continue participating in the study
Non-cooperation of the family of patients
Starting medications that affect on indices
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
84
Actual sample size reached:
80
Randomization (investigator's opinion)
N/A
Randomization description
Random Tool: Use Random Number Tables
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person assessing the delirium questionnaire did not know about the allocation of patients to the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ettiic committe of masshad Unverity of Medical Siences
Street address
Daneshgah street, Masshad unverity of medical sience, Masshad
City
Masshad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
ir.mums.rec.1395.477
Health conditions studied
1
Description of health condition studied
Relationship of the visiting based on developed protocol on the physiological parameters and delirium of patients admitted to the intensive care unit.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physiological parameters and delerium
Timepoint
In the beginning of the study and on the first, second and third day after the start of the study
Method of measurement
Delirium Nelon Champagon Questionnaire and monitoring devise
Secondary outcomes
empty
Intervention groups
1
Description
In the control group, the visiting will be done in the usual way in the intensive care unit.In the test group, the visiting will be done accordance with the developed protocol. The protocol includes the appointment of a visitor, the training of him on how to meet and control the correct implementation of the visit.