Protocol summary
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Study aim
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Determination the effect of visiting based on Developed Protocol on Physiological Parameters and Delirium of Patients Admitted to Intensive Care Unit
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Physiological Indices and Arterial Oxygen Saturation and Delirium
General information
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Reason for update
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Sampling dates information has been corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161229031654N2
Registration date:
2018-01-25, 1396/11/05
Registration timing:
prospective
Last update:
2025-10-09, 1404/07/17
Update count:
1
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Registration date
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2018-01-25, 1396/11/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice President of Research os masshad university of medical sience
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Expected recruitment start date
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2018-01-26, 1396/11/06
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Expected recruitment end date
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2019-02-09, 1397/11/20
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Actual recruitment start date
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2018-01-26, 1396/11/06
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Actual recruitment end date
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2019-02-09, 1397/11/20
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Trial completion date
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2019-02-09, 1397/11/20
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Scientific title
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Assesment the effect of visiting based on developed protocol on physiologic parameters and delirium in patient hospitslized in ICU
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Public title
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Effect of visiting based on designed protocol on physiologic parameters and delirium
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
84
Actual sample size reached:
60
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the person assessing the delirium questionnaire did not know about the allocation of patients to the control or intervention group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-12-07, 1395/09/17
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Ethics committee reference number
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ir.mums.rec.1395.477
Health conditions studied
1
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Description of health condition studied
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Relationship of the visiting based on developed protocol on the physiological parameters and delirium of patients admitted to the intensive care unit.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Physiological parameters and delerium
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Timepoint
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In the beginning of the study and on the first, second and third day after the start of the study
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Method of measurement
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Delirium Nelon Champagon Questionnaire and monitoring devise
Intervention groups
1
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only part of the information, such as information on the main outcome or the like, can be shared
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When the data will become available and for how long
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Start publishing results 6 months after the completion of the study
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To whom data/document is available
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Data will only be available to researchers in academia and academia
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Under which criteria data/document could be used
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Any analysis will be allowed
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From where data/document is obtainable
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To researcher email: Nazariz1@mums.ac.ir
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What processes are involved for a request to access data/document
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By email and within 2 weeks after receiving the request
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Comments
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