The effectiveness of tactile stimulation on level of consciousness, pain, and physiological parameters in unconscious patients admitted to the intensive care
Comparing the effect of tactile stimulation hand and foot on consciousness, pain, and physiological parameters in unconscious patients admitted to the intensive care
Design
Single -blind clinical trial with block randomized allocation and parallel group design
Settings and conduct
The statistical population of this study are unconscious
patients whose admit to the intensive care units of Shohadaye Tajrish Hospital. Assignment of patients to three groups is
carried out by a statistical expert by using blocks. Each group includes 30 patients. Demographic and clinical characteristics of the patients are recorded with questionnaire. The hand tactile stimulation group receive touch for 10 minutes, twice a day for three days.The foot tactile stimulation group receive touch for 10 minutes, twice a day for three days.The control group don't receive any sensory stimulation.
Participants/Inclusion and exclusion criteria
Age range 18 to 60 years old; The level of consciousness based on Glasgow Coma Scale is less than 12; The Richmond Criteria in the range of 3- to 3+; Existence of pain in patients by CPOT criteria; Existence of normal brain CT; Hospitalization in ICU for the first time; The lack of history of mental illness; The lack of addiction; The lack of sensory-motor dysfunction in extremities; The lack of skin problems; The lack of diseases such as diabetes .
Intervention groups
The hand tactile stimulation group receive touch for 10 minutes, twice a day,for three days. The foot tactile stimulation group receive touch for 10 minutes, twice a day, for three days. The control group don't receive any sensory stimulation.
Main outcome variables
In each group the level of consciousness, physiological parameters, and pain will be evaluated before and after intervention during three days.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110912007529N22
Registration date:2020-03-29, 1399/01/10
Registration timing:registered_while_recruiting
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2020-04-16, 1399/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of tactile stimulation on level of consciousness, pain, and physiological parameters in unconscious patients admitted to the intensive care
Public title
The effectiveness of tactile stimulation on unconscious patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 60 years old
The level of consciousness based on Glasgow coma scale is less than 12
The Richmond criteria in the range of 3- to 3+
Existence of pain in patients by CPOT criteria
Existence of normal brain CT
Hospitalization in ICU for the first time
The lack of history of mental illness
The lack of addiction
The lack of sensory-motor dysfunction in the extremities
The lack of skin problems
The lack of diseases such as diabetes
Exclusion criteria:
Concurrent participation in similar care plans such as massage
Use of receive neuromuscular blockers
Severe disorders levels of consciousness
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization which the patient was the randomization unit. Assignment of patients to groups is carried out by a statistical expert. Block selection is based on the random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Samplers and the statistical analyzer will be blind to
patients ‘random allocation of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shaded University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.SHAHEEED.REEC.1398.048
Health conditions studied
1
Description of health condition studied
comatose patient
ICD-10 code
B19.10
ICD-10 code description
Coma, unspecified
Primary outcomes
1
Description
Level of consciousness
Timepoint
Before and after intervention, twice a day, during three days
Method of measurement
The GCS and FOUR scores
2
Description
Intensity of pain
Timepoint
Before and after intervention, twice a day, during three days
Method of measurement
Critical Care Pain Observation Tool (CPOT)
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before and after intervention, twice a day, during three days
Method of measurement
The monitor used in Intensive Care Unit
2
Description
Respiratory Rate
Timepoint
Before and after intervention, twice a day, during three days
Method of measurement
The monitor used in Intensive Care Unit
3
Description
Heart Rate
Timepoint
Before and after intervention, twice a day, during three days
Method of measurement
The monitor used in Intensive Care Unit
4
Description
Oxygen Saturation
Timepoint
Before and after intervention, twice a day, during three days
Method of measurement
Pulse Oximeter
Intervention groups
1
Description
The first intervention group:The hand tactile stimulation group receive touch for 10 minutes, twice a day,11:00 am and 15:00 pm, for three days.
Category
Rehabilitation
2
Description
The second intervention group:The foot tactile stimulation group receive touch for 10 minutes, twice a day,11:00 am and 15:00 pm, for three days.
Category
Rehabilitation
3
Description
The control group don't receive any sensory stimulation.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Maryam Ahmadi
Street address
Shohadaye Tajrish Hospital, Shahrdari St, Tajrish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2150
Email
kiasalari@domain.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Nahid Rejeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 2150 5121
Email
nrejeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nahid Rejeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 2150 5121
Email
nrejeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nahid Rejeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2150
Email
nrejeh@yahoo.com
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
Yes - There is a plan to make this available
Title and more details about the data/document
All statistical data is available after being unidentifiable.
When the data will become available and for how long
The access period is up to one year after the publication of the results.
To whom data/document is available
Data is available to academic researchers.
Under which criteria data/document could be used
Use of information for academic research projects is allowed.
From where data/document is obtainable
Corresponding author; Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran, Iran.
What processes are involved for a request to access data/document
Requests for specific information should be sent by an email to the responsible author along with an explanation of why the data is needed.