Objective: To determine the effect of organized sensory stimulation program on coma recovery and disease outcomes in comatose stroke patients
STUDY DESIGN: Non-randomized clinical trial, control, phase 2
Study population: Stroke patients with consciousness disorder
Inclusion Criteria: age between 35 to 75 years; duration of coma more than 72 hours and less than 14 days; GCS between 6 and 12.
Exclusion Criteria: metabolic disorders; get sedative and narcotic medications during the study; sensory -motor disorder; stroke in the areas of visual and auditory nerves
Sample size: 80
Intervention: organized sensory stimulation program including auditory, visual, olfactory,gustatory, tactile and kinesthetic for 14 consecutive days. At first select the stimulus according to the patient favourits through the families interview and then The list of stimulus that should be used in sensory stimulation program, will be developed. Then the patient will be exposed to stimuli consecutively and regularly.
Intervention time: once a day for 14 days. Get every stimulation between 5 to 10 minutes.
The consequences of the study: One of the main outcomes is coma recovery. Another one is disease outcomes which include sensory function, cognitive function and The severity of stroke.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120831299N1
Registration date:2017-02-04, 1395/11/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-04, 1395/11/16
Registrant information
Name
Khadijeh Sargolzaei
Name of organization / entity
Mashhad University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
sargolzaeikh2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences
Expected recruitment start date
2017-01-08, 1395/10/19
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of organized sensory stimulation program on coma recovery and disease outcomes in comatose stroke patients
Public title
Sensory stimulation in Stroke comatose patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: age between 35 to 75 years; duration of coma more than 72 hours and less than 14 days; GCS between 6 and 12; the availability of one of the patient's family who is over 18 years; family consent of the patient to participate in the study; Iranian citizenship and fluent in Persian; lack of vision problems and blindness; no hearing problems; the absence of psychotic mental illness; the lack of skin problems; the lack of sedative and narcotic
Exclusion Criteria: metabolic disorders; drug addiction; get sedatives and drugs during the study; the prohibition in mobility organs; sensory-motor disorder in four limbs; patients who have suffered from a stroke in the areas of visual and auditory nerves; identification of vision problems; hearing problems; skin diseases and psychological problems during the study; sudden hemodynamic disorder that can cause critical situations for patients; died before the fourteenth days
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Next to the Hoveyzeh Cinema, Daneshgah Avenue
City
Mashhad
Postal code
Approval date
2016-05-28, 1395/03/08
Ethics committee reference number
941683
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G45, G46
ICD-10 code description
Transient cerebral ischaemic attacks and related syndromes,Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
coma recovery
Timepoint
before and after of intervention for 14 consecutive days
Method of measurement
CRS-R
2
Description
sensory function
Timepoint
before and after of intervention for 14 consecutive days
Method of measurement
SMART
3
Description
cognitive function
Timepoint
before and after of intervention for 14 consecutive days
Method of measurement
RLA
4
Description
the severiety of stroke
Timepoint
before intervention at first day, seventh and fourtheen days after intervention
Method of measurement
NIHSS
Secondary outcomes
1
Description
HemodynamicCriteria:PR,RR,BP,SPo2
Timepoint
before and after intervention for 14 consecutive days
Method of measurement
Cardiopulmonary monitoring and Sphygmomanometer
Intervention groups
1
Description
intervention group: Implication of sensory stimulation program include of auditory, visual, olfactory, gustatory, tactile and kinesthetic stimulation. At first select the stimulus according to the patients favourite through families interview and then develop the list of stimulus that should be used in sensory stimulation program. Auditory stimulation will be performed with verbal communication, tape recording of family member voices and patient favorite music. Visual stimulation will be performed with penlight, photographs of family members and mirror. In the beginning of the visual stimulation, the researcher had to hold the patients’ eyes open to vision. Olfactory stimulation will be performed with patients’ favorite aromas such as perfume, orange or lemon, coffee, vanilla,.. Gustatory stimulation will be performed with irrigation of the oral cavity with cool water, gum massage, brushing of the teeth and then lemon juice will be applied to the lateral side of tongue. Tactile stimulation will be performed with warm and cold water, applying wet towels and then the patient’s arms, hands, trunk, and legs will be massaged with olive oil. Finally kinesthetic stimulation will be performed.
Category
Other
2
Description
In the control group will not be performed any intervention except routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Mohammad Taghi Farzadfard
Street address
St. Ahmadabad, Dr Shariati Square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Next to the Hoveyzeh Cinema, Daneshgah Avenue
City
Mashhad
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 and Technology, Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences, School of Nursing and Midwifary
Full name of responsible person
Khadijeh Sargolzaei
Position
Master Student
Other areas of specialty/work
Street address
School of Nursing and Midwifary, Ibn Sina St, Doctora Intersection, Daneshgah Avenue
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
sargolzaeikh2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shool of Nursing and Midwifary
Full name of responsible person
Dr Nahid Aghebati
Position
PhD
Other areas of specialty/work
Street address
School of Nursing and Midwifary, Ibn Sina St, Doctora Intersection, Daneshgah Avenue
City
Mahhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
aghebatiz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifary
Full name of responsible person
Khadijeh Sargolzaei
Position
Master Student
Other areas of specialty/work
Street address
School of Nursing and Midwifary, Ibn Sina St, DoctoraIntersection, Daneshgah Avenue
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
sargolzaeikh2@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)