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The effect of the vibration on the level of consciousness in head trauma patients

Protocol summary

Study aim
The effect of the vibration on the level of consciousness in head trauma patients
Design
In a clinical trial, 50 head injured patients were selected through convenience sampling and were randomly assigned to intervention and control groups
Settings and conduct
50 head trauma patients were hospitalized in the ICU of Shahid Rajaee Hospital in Qazvin through the available sampling method and randomly divided into 2 groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with head trauma in the intensive care unit: patients with head trauma have a level of consciousness of 5 - 12 • Age 15 - 65 years • Patients who have had at least 72 hours of injury and SIMV ventilator mod .Exclusion criteria: * The presence of fractures, ulcers, infections and skin disease in the wrist to the ends of both toes، Limitation on the movement of the lower limbs * amputation * Patients affected by a series of cases that have history, history of diabetes, coma in the past, sensory and neurological disorders, death
Intervention groups
In the control group, routine care was performed in all centers and in the intervention group, during the 7-day period, one day for 15 minutes, using a foot massage jacuzzi massage device, the leg shake was performed. Then, immediately before the intervention, one hour and three hours after skin irritation, the level of consciousness was assessed based on Glasgow's scale and vital signs. In the control group, the level of consciousness and vital signs parallel to the intervention group was evaluated.
Main outcome variables
vital sign, vibration, level of consciousness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180731040658N2
Registration date: 2018-10-15, 1397/07/23
Registration timing: retrospective

Last update: 2018-10-15, 1397/07/23
Update count: 0
Registration date
2018-10-15, 1397/07/23
Registrant information
Name
Fateme Nazifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 5170
Email address
f.nazifi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
2017-12-21, 1396/09/30
Scientific title
The effect of the vibration on the level of consciousness in head trauma patients
Public title
The effect of the vibration on the level of consciousness in head trauma patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with head trauma with a level of consciousness of 5 – 12 age of 17-65 years patients who at least 72 hours have passed since their injury SIMV mod For patients connected to the ventilator
Exclusion criteria:
head trauma patients who based on records and history have a history of the diabetes, a history of coma in the past and a history of sensory and neurological disorders fracture, ulcer, infection and skin disease in the wrist to the extremities of both feet fingers, limitation of movement of the lower limbs lower limb amputation Patients receiving infusion of sedation medication can not be stopped death
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling At first, the random allocation of samples was done for two groups of control and intervention using a two-ball orbital draw, so that the white ball indicates the control group and the red ball indicates the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2017-04-15, 1396/01/26
Ethics committee reference number
IR.QUMS.REC.1396.26

Health conditions studied

1

Description of health condition studied
Head trauma patients
ICD-10 code
S00.90XA
ICD-10 code description
Unspecified superficial injury of unspecified part of head, initial encounter

Primary outcomes

1

Description
level of consciousness
Timepoint
Control the level of consciousness before, one and three hours after the intervention with vibration
Method of measurement
GCS Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Performing vibration with 50 Hz Frequency of legs from fingers to ankles using a jacuzzi massager machine Made in China once a day for 15 minutes after an appointment and for 7 consecutive days
Category
Rehabilitation

2

Description
Control group: Control group: In the control group, the usual care was taken in all centers. In the control group, the level of consciousness and vital signs parallel to the intervention group was evaluated and recorded
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaee hospital in Qazvin
Full name of responsible person
Fateme Nazifi
Street address
Shahid Rajaee hospital, North Padegan Street
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Email
hosrajaee@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Amir Peimani
Street address
Qazvin University of Medical Sciences، Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 8034
Email
f.nazifi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Nazifi
Position
Nurse, student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 92, Alley 33, Shahid Babaei Street
City
Qazvin
Province
Qazvin
Postal code
3414678113
Phone
+98 28 3368 5170
Fax
Email
f.nazifi@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Nazifi
Position
Nurse, student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 92, Alley 33, Shahid Babaei Street
City
Qazvin
Province
Qazvin
Postal code
3414678113
Phone
+98 28 3368 5170
Fax
Email
f.nazifi@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Nazifi
Position
Nurse, student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 92, Alley 33, Shahid Babaei Street
City
Qazvin
Province
Qazvin
Postal code
3414678113
Phone
+98 28 3368 5170
Fax
Email
f.nazifi@qums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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