(1)Objectives:This designed study aimed to the effect of regular meeting of families on Physiological Parameters and Recovery Process in non-ventilated CVA Patients in ICU.
(2)Design:Intensive care unit patients are faced with many stressors which includes artificial light during 24 hours, Continuous noise monitoring machine and respiratory support, lack of meaningful stimulus as touched by members of family and Physical pain or discomfort caused by disease.
The volume of the sample for each group is stated 28 but it is considered that there might be a reduction in the sample of 34 in each group.
(3)Setting and conduct:The presence of family members(to have Strong emotional relationship with a person hospitalized)In intensive care units two times per day in the first six Admission Besides patient and doing Trained health care activities
(4)Inclusion criteria included: Family consent for participating in research؛non-ventilated patient؛older than 18 years؛not part of the clinical staff.
Exclusion criteria:Require mechanical ventilation during the research؛death of patient؛transferred to other hospitals؛withdrew from participation in the study for any reason.
(5)Intervention included:Care activities such as Tactile contact with the patient during care, cleaning the eyes of patients with wet sterile gauze, Use Softener hands and feet in patients.
(6)main outcome measures (variables) Included:Physiological Parameters and Scale Recovery Process
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122715954N1
Registration date:2014-03-09, 1392/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-09, 1392/12/18
Registrant information
Name
Mohammad Reza Jani
Name of organization / entity
Medical University Gonabad
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3513
Email address
jani.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical University Gonabad, Vice chancellor for Research
Expected recruitment start date
2013-08-22, 1392/05/31
Expected recruitment end date
2014-05-05, 1393/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Regular meeting of Families on Physiological Parameters and Recovery Process in non-ventilated CVA Patients in ICU
Public title
Effect meets on improving patient meets
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Family Satisfaction for participating in research؛non-ventilated patient؛the presence of family members at the meeting (spouse, mother, father, son, brother and sister)؛no underlying disease was diagnosed as cancer, tuberculosis, hepatitis (Patient)؛first-degree relatives(spouse, mother, father, son, sister, brother)؛older than 18 years؛not part of the clinical staff؛not suffering members of family from The mood disorder - emotional diagnosed that prevent from effective communication؛not suffering from a cold visitors؛ patient is having nasal-gastric catheter.
Exclusion criteria:Require mechanical ventilation during the research؛discharged before the sixth day of the ICU؛death of patient؛Transferred to other hospitals؛withdrew from participation in the study for any reason
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
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 the Medical University Gonabab
Street address
Medical University Gonabad, Vice chancellor for Education and Research, road edges, Asian, Khorasan Razavi, Gonabad
City
Gonabad
Postal code
9691793718
Approval date
2013-12-25, 1392/10/04
Ethics committee reference number
gmu.rec.1392.21
Health conditions studied
1
Description of health condition studied
Cerebrovascular accidents
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Improving process
Timepoint
Six Days
Method of measurement
Cheek List APACHE II
2
Description
Physiological indicators
Timepoint
Six Days
Method of measurement
Cheek List
Secondary outcomes
1
Description
Regular meeting
Timepoint
Fifteen minutes before the meeting, During the half-hour meeting and fifteen minutes after meeting for six days
Method of measurement
Questionnaire
Intervention groups
1
Description
The presence of family members(to have Strong emotional relationship with a person hospitalized)In intensive care units two times per day in the first six Admission Besides patient and doing Trained health care activities
Category
Other
2
Description
The control group does not intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital Ghaen
Full name of responsible person
Mohammad Reza Jani
Street address
Shohada Hospital, Cement City, St Healing, Ghaen Boulevard, South Khorasan