The effect of programmed tactile and auditory stimulations on consciousness level and cardiopulmonary parameters in patients with decreased consciousness level admitted in intensive care units.
This study was conducted to determine effect of sensory stimulation on consciousness level and cardiopulmonary parameters of critical care patients. Inclusion criteria: patients from eighteen to sixty years old; admitted to ICU greater than 24 hours; consciousness level between 4 to 12 base on FOUR scale; presence of hemodynamic and electrolytes stability according to doctor idea. Exclusion criteria: malignancy and cardiopulmonary disease according to doctor idea; discharge from the ICU before fourth day and surgery after admitted. Participants were 50 patient hospitalized in intensive care unit that selected using convenience sampling and divided in 2 groups control and intervention. First, patient's consciousness level and cardiopulmonary parameters (systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, respiratory rate and arterial blood oxygen saturation) were measured and recorded before intervention. In intervention group, the patient family after wearing gown and Slippers, washing hands and training about the correct procedure entered to ward and touched the patient and talked with him for 15 minute under the supervision of researcher, then left the ward for 2 hours, after that the intervention repeated in the same procedure. Consciousness level and cardiopulmonary parameters were recorded 30 minutes after intervention. In controls group simultaneously without any intervention consciousness level and cardiopulmonary parameters were recorded in 16 and 19 o clock.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014053117915N1
Registration date:2014-07-12, 1393/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-12, 1393/04/21
Registrant information
Name
mehdi sahebi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0439
Email address
m.sahebi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2014-03-06, 1392/12/15
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of programmed tactile and auditory stimulations on consciousness level and cardiopulmonary parameters in patients with decreased consciousness level admitted in intensive care units.
Public title
The effect of family communication and touch on unconscious patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patient from eighteen to sixty years old; admitted to ICU greater than 24 hours; consciousness level base on FOUR scale between 4 to 12; presence of hemodynamic and electrolytes stability according to doctor idea; pass at least 6 hours from the time of opioid or sedative drugs injection. Exclusion criteria: malignancy and cardiopulmonary disease according to doctor idea; discharge from the ICU before fourth day and surgery after admitted.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethical Human Subject Review Board of Hamadan University of Medical Sciences
Street address
University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
/16/35/9/4193/P/D
Health conditions studied
1
Description of health condition studied
decreased level of consciousness
ICD-10 code
R40.2
ICD-10 code description
Coma, unspecified
Primary outcomes
1
Description
level of consciousness
Timepoint
Before and 30 minutes after intervention
Method of measurement
FOUR scale
2
Description
Systolic blood pressure
Timepoint
Before and 30 minutes after intervention
Method of measurement
Connected to patient hemodynamic manitoring
3
Description
Diastolic blood pressure
Timepoint
Before and 30 minutes after intervention
Method of measurement
Connected to patient hemodynamic manitoring
4
Description
Mean arterial blood pressure
Timepoint
Before and 30 minutes after intervention
Method of measurement
Connected to patient hemodynamic manitoring
5
Description
Respiratory rate
Timepoint
Before and 30 minutes after intervention
Method of measurement
Connected to patient hemodynamic manitoring
6
Description
Oxygen sauration
Timepoint
Before and 30 minutes after intervention
Method of measurement
Connected to patient hemodynamic manitoring
7
Description
Heart rate
Timepoint
Before and 30 minutes after intervention
Method of measurement
Connected to patient hemodynamic manitoring
Secondary outcomes
empty
Intervention groups
1
Description
This intervention is performed in three 5 minute section twice on day between 16-16:15 and 18-18:15 hours for four day in the afternoon. The families in the intervention group after wearing gown and Slippers and washing hands and rubbing them with antibacterial jel enter the ward and sit on the chair near the bed, call the patient by one’s normal intonation, introduce oneself, hold the patient’s hands, touch the patient gently, talk to the patient about all the measures that had been done for the patient’s improvement Then, in the second 5 min of the visit, the visitor again should touch the patient’s hands and face, make the patient familiar with the time and place, and In the third set of 5 min, the visitor should touch the patient again, say goodbye, and finally state the time of the next visit.
Category
Rehabilitation
2
Description
In control group did not perform any intervention exception of routin nursing care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Ghlam Hossein Falahinia
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Heidar Tavilani
Street address
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Department of Medical Surgical Nursing
Full name of responsible person
Ghlam Hossein Falahinia
Position
Master of nursing
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Av
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0439
Fax
Email
falahinia@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Medical Surgical Nursing
Full name of responsible person
Ghlam Hossein Falahinia
Position
Master of Nursing
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0439
Fax
Email
falahinia@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan university of medical science
Full name of responsible person
Mehdi sahebi
Position
Master of Critical Care Nursing Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3837 8097
Fax
Email
mehdi-sahebi@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)