The effect of planned sensory stimulation performed by family members and nurses on the level of consciousness ,vital signs and Oxygen saturation in patients admitted to Intensive care unit
investigation the effect of planned sensory stimulation performed by family members and nurses on the level of consciousness ,vital signs and Oxygen saturation in patients admitted to Intensive care unit
Design
This study is a double-blind clinical trial.The study population will be included all patients referring to the ICU of Imam Reza hospital in Kermanshah city.115 eligible patients will be selected conveniently and randomly assigned to three groups (two intervention and one control group)
Settings and conduct
This study, which will be carried out at Imam Reza Hospital in Kermanshah city a double-blind clinical trial, that the patients and the outcome evaluator were kept blind to the study groups and at the beginning of the study, the level of consciousness, vital signs, and arterial oxygen saturation in all three groups will be recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The level of patients consciousness be between 6 and 12;The patient already has no history of mental illness, GCS fluctuations within a few days prior to the trauma (the Delirium term in this research) and admitted to a mental hospital
Exclusion criteria:Patients get delirium;The patient will be fully aware after the recovery of disease
Intervention groups
The first intervention group will receive sensory stimulation by a family member every day for 2 hours, from 4 to 5 in the evening and 8 to 9 in night with 3 hours distance and for 6 days.
The second intervention group will receive sensory stimulation by researcher every day for 2 hours, from 4 to 5 in the evening and 8 to 9 in night with 3 hours distance and for 6 days.
Control group will not receive any sensory stimulation.
Main outcome variables
The level of consciousness, vital signs, and arterial oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160308026961N5
Registration date:2018-07-04, 1397/04/13
Registration timing:registered_while_recruiting
Last update:2018-07-04, 1397/04/13
Update count:0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Shila Amini
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 988138380320
Email address
sh.amini@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of planned sensory stimulation performed by family members and nurses on the level of consciousness ,vital signs and Oxygen saturation in patients admitted to Intensive care unit
Public title
The effect of planned sensory stimulation on the level of consciousness ,vital signs and Oxygen saturation in patients in patients admitted to the ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Visitors are only the main members of the family (father, mother, spouse, child, sister, brother) and their age is over 18 years of age.
Patients is hospitalized with head trauma (Types of brain hematomas and other lesions, except diffuse axon damage)
The patient has pupil reflexes at the entrance to the ICU section.
The level of patients consciousness be between 6 and 12
The patient already has no history of mental illness, GCS fluctuations within a few days prior to the trauma (the Delirium term in this research)
It has not been more than 3 days passed since the patient's admitted to the Intensive Care Unit
Exclusion criteria:
History of admission to a psychiatric hospital
Visitors younger than 18 years of age
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
115
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with stratified blocking method (based on the age group with 10 years distance, 16 to 25, 26 to 35, 36 to 45, 46 to 55, and 56 to 65) will be randomly divided into three groups and within each block, half of the intervening and half-blind individuals are considered as witnesses to balance the number of participants in each of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and outcome evaluators will be blinded to the study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
kums.rec.1395.509
Health conditions studied
1
Description of health condition studied
Patients with head trauma
ICD-10 code
S09.9
ICD-10 code description
Unspecified injury of head
Primary outcomes
1
Description
the level of consciousness
Timepoint
10 minutes before the intervention and 30 minutes after the intervention
Method of measurement
Using the Glasgow Coma Scale (GCS)
2
Description
Vital signs
Timepoint
10 minutes before the intervention and 30 minutes after the intervention
Method of measurement
Using a cardio-respiratory monitoring device and an oxilary thermometer
3
Description
Arterial oxygen saturation
Timepoint
10 minutes before the intervention and 30 minutes after the intervention
Method of measurement
Using a cardio-respiratory monitor
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive sensory stimulation by a family member every day for 2 hours, from 4 to 5 in the evening and 8 to 9 in the night with 3 hours distance and for 6 days. Sensory stimulation program includes sight, auditory, smell, touch and kinesthetic stimulation. Olfactory stimulating by taking alcohol in front of the patient's nose for 5 seconds, sight stimulating by turning the flashlight on and off in front of the patient's eyes for 2 seconds,auditory stimulation by calling the patient's own name, time, place and day near the patient's ear three times,touch stimulating by squeezing and massage and rub the skin with cotton and guas, first, one side of the body and then the other side, kinesthetic stimulation by moving the joints of the hands and feet, the wrist, the hip joint and shoulder joint by bending and straightening, and alternating up and down the arms and legs 15 times, and each of the stimuli is performed once per hour
Category
Treatment - Other
2
Description
The second intervention group will receive sensory stimulation by researcher every day for 2 hours, from 4 to 5 in the evening and 8 to 9 in the night with 3 hours distance and for 6 days. Sensory stimulation program includes sight, auditory, smell, touch and kinesthetic stimulation. Olfactory stimulating by taking alcohol in front of the patient's nose for 5 seconds, sight stimulating by turning the flashlight on and off in front of the patient's eyes for 2 seconds,auditory stimulation by calling the patient's own name, time, place and day near the patient's ear three times,touch stimulating by squeezing and massage and rub the skin with cotton and guas, first, one side of the body and then the other side, kinesthetic stimulation by moving the joints of the hands and feet, the wrist, the hip joint and shoulder joint by bending and straightening, and alternating up and down the arms and legs 15 times, and each of the stimuli is performed once per hour
Category
Treatment - Other
3
Description
The control group will not receive any sensory stimulation.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Kamran Vafaee
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4609
Email
K.VAFAEE60@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
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 of Kermanshah 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
Emam Reza Hospital
Full name of responsible person
Shila Amini
Position
Masters student of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 834276301
Fax
Email
k.vafaee1360@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Reza Hospital
Full name of responsible person
Kamran Vafaee
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6301
Fax
Email
k.vafaee1360@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam Reza Hospital
Full name of responsible person
Shila Amini
Position
Masters student of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Fax
Email
sh.amini@edu.umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail