Effect of planned nursing interventions versus no intervention on acute urinary retention in patients who are candidate for cardiac catheterization: a randomized clinical trial
Objectives: To assess the effect of planned nursing interventions versus no intervention on acute urinary retention in patients who are candidate for cardiac catheterization.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients who are candidate for cardiac catheterization and will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Male patients who are candidate for elective cardiac catheterization.
Exclusion criteria: History of urinary catheterization; urinary tract stone; urinary tract infection; urinary stenosis; constipation; nerves disorders; cerebrovascular accidents; using psychiatric medications, calcium channel blockers; alpha blockers; narcotics; or diuretics.
Intervention group: Routine care plus specific nursing care including education of correct urination and putting basin and urinary tube at bedside and using wet gauze on suprapubic area.
Control group: Just routine care.
Primary outcome: Assessing acute urinary retention before and 1, 2, 4, and 6 hours after cardiac catheterization through taking history and physical examination.
Secondary outcome: Nothing.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609209014N116
Registration date:2016-09-22, 1395/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-10-09, 1394/07/17
Expected recruitment end date
2016-02-29, 1394/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of planned nursing interventions versus no intervention on acute urinary retention in patients who are candidate for cardiac catheterization: a randomized clinical trial
Public title
Effect of planned nursing interventions versus no intervention on acute urinary retention in patients who are candidate for cardiac catheterization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Male patients who are candidate for elective cardiac catheterization.
Exclusion criteria: History of urinary catheterization; urinary tract stone; urinary tract infection; urinary stenosis; constipation; nerves disorders; cerebrovascular accidents; using psychiatric medications, calcium channel blockers; alpha blockers; narcotics; or diuretics.
Age
No age limit
Gender
Male
Phase
2
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
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.UMSHA.REC.1394.216
Health conditions studied
1
Description of health condition studied
Cardiac catheterization
ICD-10 code
Y84.0
ICD-10 code description
Cardiac catheterization
Primary outcomes
1
Description
Assessing acute urinary retention
Timepoint
before and 1, 2, 4, and 6 hours after cardiac catheterization
Method of measurement
through physical examination
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Routine care plus specific nursing care including education of correct urination and putting basin and urinary tube at bedside and using wet gauze on suprapubic area
Category
Treatment - Other
2
Description
Just routine care
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mohammad Reza Setvati Basir
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid 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
Vice-chancellor for Research the Technology, 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
School of Nursing and Midwifery
Full name of responsible person
Mohammad Reza Setvati Basir
Position
Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
m.r_setvati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Mohammad Reza Setvati Basir
Position
Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
m.r_setvati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)