Impact of sensory excitation performed by family members and nurses on the level of consciousness and vital signs in patients who are admitted to Intensive care unit and the general health of their families
The patients who are admitted to Intensive care unit (ICU) are exposed to sensory deprivation. Studies have shown that sensory excitation has a positive effect on preventing sensory deprivation. However the role of family members in sensory stimulation, compared with nurses has not yet been studied. The goal of this study is to compare sensory excitation delivered by family members and nurses on the level of consciousness and vital signs in patients who are admitted to ICU and the general health status of their families in a clinical trial design. In this study 73 patients admitted to ICU (having head injury, GCS 6-12, age 16-65 years) will be randomly assigned into two test and one control groups. The first group will receive sensory excitation by family members (first-degree relatives, above 18 years old). The second group will receive sensory excitation by nurses and third group (control group) will receive no intervention. The intervention is Dying sensory excitation program. It will be applied two hours a day at 4-5 pm and 8-9 pm to the test groups for six days. For all subjects in these three groups, the level of consciousness and vital signs (Blood Pressure, Temperature, Respiratory Rate, and Pulse Rate) will be measured twice at 5 minutes before intervention and 30 minutes after intervention by the research assistant (a person other than the one who performs excitation). Family members general health status will be measured via interview before and after the 1st, 6th and 12th hourly intervention session in all groups using General Health Questionnaire (GHQ).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204149469N1
Registration date:2012-06-30, 1391/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-30, 1391/04/10
Registrant information
Name
Mohammad Adineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0140
Email address
mohadineh@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Lorestan University of Medical Sciences.
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-07-21, 1391/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of sensory excitation performed by family members and nurses on the level of consciousness and vital signs in patients who are admitted to Intensive care unit and the general health of their families
Public title
Impact of sensory excitation performed by family members and nurses on the level of consciousness and vital signs in patients who are admitted to Intensive care unit and the general health of their families
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria (patients): head injury - GCS 5 to 10 - age16 to 65 years - obtained informed consent to participate in the study from family members,...
Exclusion criteria: discharge from the ICU before sixth day,... Inclusion criteria (family members): first-degree relatives - older than 18 years,...
Inclusion criteria ( nurses): Trained Nurses
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
73
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
Ethics Committee of Lorestan university of medical sciences
Street address
Ethics Committee, Vice chancellor for research, Lorestan university of medical sciences.
5 minutes before intervention and 30 minutes after intervention
Method of measurement
Glasgow coma score
2
Description
Patient's vital signs
Timepoint
5 minutes before intervention and 30 minutes after intervention
Method of measurement
Respiratory-cardiac monitoring system
3
Description
Family members general health
Timepoint
immediately before and after the 1st, 6th and 12th hourly intervention session
Method of measurement
GHQ
Secondary outcomes
1
Description
Hospitalization period in ICU
Timepoint
Number of days hospitalized
Method of measurement
Checklist
Intervention groups
1
Description
Second test group patient: Dying sensory excitation program will be delivered by nurses. It will be applied two hours a day at 4-5 pm and 8-9 pm to the test groups for six days.
Category
Treatment - Other
2
Description
Control group patient: do not received Dying sensory excitation program, received Routine care.
Category
Treatment - Other
3
Description
First test group patient: Dying sensory excitation program will be delivered by family members. It will be applied two hours a day at 4-5 pm and 8-9 pm to the test groups for six days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ashair hospital, ICU
Full name of responsible person
Mohammad Adinevand
Street address
Engelab st, Ashair hospitals.
City
Khoramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Lorestan university of medical sciences
Full name of responsible person
Dr. Mohammad Hassan Kayedi
Street address
Vice chancellor for research, Lorestan university of medical sciences.
City
Khorramabad
Grant name
124409010
Grant code / Reference number
1192
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Lorestan 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
Lorestan university of medical sciences
Full name of responsible person
Mohammad Adinevand
Position
Postgraduate student, Master of nursing Sciences
Other areas of specialty/work
Street address
Department of Nursing, School of Nursing and Midwifery, Lorestan university of medical sciences.
City
Khorramabad
Postal code
381351698
Phone
+66 16200140
Fax
+98 66 1620 0140
Email
mohadineh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan university of medical sciences
Full name of responsible person
Tahereh Toulabi
Position
master of nursing Sciences
Other areas of specialty/work
Street address
Department of Nursing, School of Nursing and Midwifery, Lorestan university of medical sciences.
City
Khorramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0138
Email
tolabi_t@lums.ac.ir; Toulabi_t@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan university of medical sciences
Full name of responsible person
Mohammad Adinevand
Position
student in master of nursing Sciences
Other areas of specialty/work
Street address
Department of Nursing, School of Nursing and Midwifery, Lorestan university of medical sciences.
City
Khorramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0138
Email
mohadineh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)