We will compare the impact of two methods; Routine Physical restraint and attendance of patients on patient's blood cortisol levels in Intensive Care Units. 18 Patients who will physically restrain routinely by nurses and more than three days are in the ICU will randomly divide into two groups. Study will carry out on two consecutive days. In group 1, in the first day, 30 min after the release of restraint, patients will then physically restrain for 1 hour. In second day of study we will use from attendance instead of restraint in the same manner. In group 2, we will study about the impact of attendance on blood cortisol levels in the first day and then about the physical restraint in second day. The blood samples should take before the intervention in first day and after the intervention in first and second days in two groups. We will analyze the results of two groups. Any severe change in the condition of the patient during two days of therapy and during any invasive procedure, causing the withdrawal of the patient from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110415271N1
Registration date:2013-12-03, 1392/09/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-12-03, 1392/09/12
Registrant information
Name
Mojdeh Navidhamidi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4314
Email address
m-navid@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Student dissertations and academic plans
Expected recruitment start date
2013-12-06, 1392/09/15
Expected recruitment end date
2014-01-30, 1392/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of physical restraint application and family bedside on blood cortisol in patients hospitalized in intensive care units.
Public title
Care of patient hospitalized in critical care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: All patients were hospitalized for more than three days in the ICU during the study;The pateints should not given any corticosteroids, anti-seizure drugs and insulin during study .The pateints should not suffer from sepsis (widespread infection of the blood); The pateints should take stable blood electrolytes.
Exclusion criteria: Patient's death;any Severe change in the condition of the patient during the two days of study; Use of any invasive procedure during the study; Release of restraint by employees; Legal guardian dissatisfaction to the continuation of the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran univercity of medical sciences and health services
Street address
Research Council of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
14 / 130 /د/92
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
Z74.0
ICD-10 code description
Need for assistance due to reduced mobility
Primary outcomes
1
Description
Cortisol
Timepoint
Before intervention, one houre aftter intervention
Method of measurement
Elisa Method
Secondary outcomes
empty
Intervention groups
1
Description
Control Group:
Category
Prevention
2
Description
Intervention Group: In the presence of researcher, patient should be free of physical restraint for 30 min and then attendance of patient will be ready beside the patient. After then we will take the blood sampling from the patient and the cortisol level will measure on a laboratory.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Masood Ahmadpoor
Street address
Jeneral Icu, Valiasr hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Fatemeh Fathi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms Anoosheh
Street address
Research Council of Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Dr. Mojdeh Navid hamidi
Position
Assistant Prof of Phisiology, Head of Medical Basic Sciences
Other areas of specialty/work
Street address
Tohid Square, School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6105 4314
Fax
Email
m-navid@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojdeh Navidhamidi
Position
Assistant Prof , Ph.D. of Physiology
Other areas of specialty/work
Street address
Tohid Square, School of Nursing and Midwifery, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4314
Fax
Email
m-navid@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojdeh Navidhamidi
Position
Assistant Prof. Ph.D. of Physiology
Other areas of specialty/work
Street address
Tohid Square, School of Nursing and Midwifery, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4314
Fax
Email
m-navid@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)