Protocol summary

Study aim
comparison of the effect of warm bath with and without vibration on the level of consciousness of head trauma patients in Shahid Rajaee Hospital of Qazvin
Design
A clinical trial, 100 head trauma, control group with parallel groups were selected by convenience sampling and were randomly assigned to intervention and control groups
Settings and conduct
100 head trauma patients were hospitalized in the ICU of Shahid Rajaee Hospital in Qazvin through the available sampling method and randomly divided into 4 groups
Participants/Inclusion and exclusion criteria
Entry 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 Exit 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
Intervention groups
In the control group, routine care was performed, and in the intervention group, for 7 days, once a day for 15 minutes, using a jacuzzi massage device. The first method was a warm foot without vibration And pouring water at a temperature of ± 40 ° C was carried out inside the machine. In the second method, the foot warm bath was performed at a frequency of 50 Hz. In the third method, only shaking feet without hot water was used. 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
warm footbath, vital sign, vibration, level of consciousness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180731040658N1
Registration date: 2018-08-19, 1397/05/28
Registration timing: retrospective

Last update: 2018-08-19, 1397/05/28
Update count: 0
Registration date
2018-08-19, 1397/05/28
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
empty
Scientific title
Comparison of warm baths with and without vibration on level of consciousness in patients with head trauma who admitted to the intensive care unit
Public title
Investigating the effect of warm bath and vibration on the level of consciousness of patients with head trauma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with head trauma, based on the GCS, a level of consciousness of between 5 and 12 Patients with head trauma range from 15 to 65 years Patients with head trauma, which was 72 hours past their injury
Exclusion criteria:
The presence of fractures, ulcers, infections and skin disease in the wrist to the extremities of both fingers, limitation of movement of the lower limbs Lower limb amputees Patients who have a history of coma in the past have a sensory and neurological disorder, based on history records and history of diabetes
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
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. After placing the specimen in the intervention group, a draw of three blue, green and yellow balls was used in the intervention group, so that the blue ball indicates the intervention of warm water, the green ball indicates the intervention of warm water and vibration and the yellow arrow indicates vibration
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
Change in consciousness level based on GCS
Timepoint
Measurement of consciousness level of samples immediately before intervention, 1 and 3 hours after intervention with warm water and vibration and also its measurement in the control group
Method of measurement
Use Glasgow Cams Scale

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, the patients were eligible for 7 days, once a day, 18 to 16 hours, using a jacuzzi massage device in China for a period of 15 minutes, making the Chinese bath warm feet with and without vibration from the wrists to the femurs of skin irritation. Intervention group: First intervention: The warm bath was carried out without vibration and pouring of water at a temperature of 2± 40 ° C. The second step was a warm foot bath with 50 Hz oscillation of the frequency using a Jacuzzi massager. Third intervention: Only the vibration of the feet without warm water was used.
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
Other

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?
Yes
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
Bachelor
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
Bachelor
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
Bachelor
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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