Assesment of the effect of a care program on the frequency of constipation following stroke in patients admitted to Alzahra Hospital in 2018
Design
In two groups, the test and control using the random number table and closing the eyes and putting the finger on one of the numbers will be the number. To move horizontally to the right, next to the top and then to the left of the table will be the number of patient beds in the two groups of test and control (66 to control and 66 to the case group).
Settings and conduct
In this research, the samples will be selected initially in a simple continuity method, which will be among the patients admitted to the intensive care units 2, the stroke unit and the internal nerves section of Al Zahra Hospital, which will have acceptable conditions for entry into the research. They will be elected to the desired level
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients who are suffering from constipation following of stroke that admitted to the hospital are enrolled in the study
Exclusion criteria: Patient's death
Intervention groups
The first group includes patients with constipation receiving a new nursing care program. The second group includes patients who receive routine care.
Main outcome variables
Post Stroke Constipation
General information
Reason for update
Acronym
CPSC
IRCT registration information
IRCT registration number:IRCT20181008041273N1
Registration date:2019-03-10, 1397/12/19
Registration timing:registered_while_recruiting
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
shayan alijanpour.sh@live.com
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3238 3454
Email address
alijanpour.sh@live.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of The Effect Of Care Plan On Post Stroke Constipation Frequency
Public title
The Effect Of Care Plan On Post Stroke Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are examined by a neurologist and their illness is confirmed.
The patient (if he / she is alert) or his / her companion will have informed consent to participate in the study.
Patients do not have concurrent participation in another study.
The doctor will allow the patient to participate in this study.
Being over 18 years old.
After a stroke, have been admitted for at least one week
Having constipation according to Rome's criterion (having at least two criteria)
Exclusion criteria:
No history of chronic constipation before a stroke, in which the patient has referred to a doctor or has received a medication.
No history of malignant tumors, colon diseases like irritable bowel, etc. Based on a patient report and information contained in the case
Lack of water and electrolyte imbalance due to kidney problems
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by random block method
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 Isfahan University of Medical Sciences
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.320
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I66.0
ICD-10 code description
Occlusion and stenosis of middle cerebral artery
Primary outcomes
1
Description
constipation frequency according Bristol scale
Timepoint
before, discharge time, one month after discharge
Method of measurement
rome IV, Bristole
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group includes patients who undertake a water and electrolyte correctional nursing program, modify the diet, control medicine, massage therapy, train patients during discharge and follow up. care
Category
Other
2
Description
Control group: Includes patients who receive routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospita
Full name of responsible person
Shayan Alijanpour
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
4745113718
Phone
+98 11 3238 3454
Email
alijanpour.sh@live.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research Deputy
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
4745113718
Phone
+98 11 3238 3454
Email
alijanpour.sh@live.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Nasrolah alimohamadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neurology
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
4745113718
Phone
+98 11 3238 3454
Email
alimohamadi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nasrolah alimohamadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neurology
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
4745113718
Phone
+98 11 3238 3454
Email
alimohamadi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shayan Alijanpour.sh@live.com
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Pazevar
City
Babolsar
Province
Mazandaran
Postal code
4745113718
Phone
+98 11 3238 3454
Fax
Email
alijanpour.sh@live.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available