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The effect of the family participation based on affective stimulations on improving the level of consciousness patients with brain trauma.

Protocol summary

Summary
Objectives: The objective of the study is to determine the effectiveness of the family participation based on affective simulations on improving the patients with brain trauma hospitalized in ICUs. Design: This study is conducted as a combined embedded study in which the qualitative part of the study is of the clinical trial type and at least 60 patients with brain trauma were put in three groups (intervention, control and placebo groups) by permutated sampling method as randomly. This study is as a triple blind study in which the patient, researcher and information analyzers are not informed of the intervention received by the patient. Setting and Conduct: In intervention group, the family participation has been made through regular visits and establishing defined communications with the patient in two morning and afternoon times for 7 days by a close member of the family and in placebo group the same intervention was done by a strange person and also, in control group the visit will be made as is routine in ICUs (from behind the window). Participants: Inclusion criteria include the brain trauma patients having level of consciousness based on Glasgow Coma Scale between 5 -8 and the family of these patients must be the first degree members of the patients (father, mother, sister, brother, child, wife/husband) and exclusion criteria include the death of patient, transferring of patient to the other centers during the study, and operating a surgery during the study. Main outcome measures: Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201503048069N3
Registration date: 2016-02-01, 1394/11/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Fatemeh Salmani
Name of organization / entity
Esfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1581 2914
Email address
f-salmani@iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the family participation based on affective stimulations on improving the level of consciousness patients with brain trauma.
Public title
Evaluating of the family participation based on affective simulations on improving the level of consciousness patients with brain trauma hospitalized in ICUs: A combined embedded study.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Family inclusion criteria: He/She can be considered as the first degree relative of the patient (father, mother, sister, brother, child, wife/husband) , having the ability of verbal communication with the others, the age of relative would be in the range of 18 and lower than 65 years old. Patients' inclusion criteria: Hospitalizing with Head injury (brain trauma) diagnosis, the level of consciousness based on Glasgow Coma Scale between 5 -8, the age of patient between 18-65 years old. Exclusion criteria: The death of patient during the study, transferring of patient to the other centers during the study, operating a surgery during the study, withdrawing the patient's family to continue to participate in the study, discharge of patient from the unit before 7 days of hospitalization time, having background diseases such as Alzheimer, Parkinson, brain stroke and so on.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Medical of Science of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Tehran
City
Tehran
Postal code
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
IR.TMU.REC.1394.22

Health conditions studied

1

Description of health condition studied
Head trauma
ICD-10 code
S00-S09
ICD-10 code description
Injuries to the head

Primary outcomes

1

Description
Level of consciousness
Timepoint
Twice a day,before and immediately after the intervention
Method of measurement
By Glasgow Coma Scale and Coma Recovery Scale

Secondary outcomes

1

Description
Length of stay in the intensive care unit
Timepoint
Once, when discharged from ICU
Method of measurement
By Level of Consciousness Questionnaire

Intervention groups

1

Description
In intervention group, family participation through Regular visits and establishing defined communications with the patient as sensory and affective simulations are done by a close member of the family twice a day (morning and evening) for 7 days. : Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale.
Category
Treatment - Other

2

Description
In placebo group, visit and sensory simulations are made by an unfamiliar trained person who has no affinity, affective and family relations with the patients twice a day (morning and evening). Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale.
Category
Treatment - Other

3

Description
In control group, care and visit would be made as is routine in ICUs (the family visit from behind the window and from the distant). Before and immediately after the intervention, the level of consciousness the patients would be measured using two tools: Glasgow Coma and recovery Coma scale.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Azahra Hospital
Full name of responsible person
Dr Majeed Rezvani
Street address
Sofeh street, Alzahra hospital,Esfahan
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Tarbiat Modares
Full name of responsible person
Dr Mansoreh Movahedin
Street address
University of Tarbiat Modares, Nasr Bridge, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Tarbiat Modares
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
Tarbiat Modares University
Full name of responsible person
Mansoreh Movahedin
Position
Vice chancellor for research
Other areas of specialty/work
Street address
University of Tarbiat Modares, Nasr Bridge, Tehran
City
Tehran
Postal code
Phone
+98 21 8288 4502
Fax
Email
movahed.m@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Esa Mohammadi
Position
Professor of Nursing
Other areas of specialty/work
Street address
Tarbiat Modares University, Nasr Bridge,Tehran
City
Tehran
Postal code
Phone
+98 21 8288 3585
Fax
Email
mohamade@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Salmani
Position
Nursing of phD Student
Other areas of specialty/work
Street address
N54, Ebn yamin avenue, Parvin street, Esfahan
City
Esfahan
Postal code
Phone
+98 31 3627 0134
Fax
Email
f-salmani@iaun.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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