Protocol summary

Study aim
The effect of an educational package provided to nurses on the quality of nursing care of patients candidate for plaster casting
Design
Clinical trial, before-after comparison, single blinded, with non-parallel groups of 188 patients.
Settings and conduct
The study will be conducted in Shahid Behesti Hospital of Kashan. Before the intervention, the first researcher will daily refer to the emergency and orthopedics units to found eligible samples. Then, using a checklist, the quality of care of patients with plaster casting will be assessed. After completing the first phase, the second researcher will provide an educational package in the form of lectures, instructional CDs, booklet and pamphlets to nurses of each unit. Then, using the same checklist, the second researcher will again assess the quality of nursing care before, during and after plaster casting. The observation will be continues till the sample size is completed. Nurses will be unaware that they are under observation. For this reason, before the data collection starts, the first researcher will be present in the research setting (in the form of student work), to normalize her presence.
Participants/Inclusion and exclusion criteria
A patient with a fracture in upper or lower extremities; A patient who is admitted to Shahid Beheshti Hospital of Kashan; A patient who is candidate for plaster casting or being plastered; Nurses with a Bachelor of Science degree and at least six months of working experience; A nurse working in the trauma emergency and orthopedic units. Lack of willingness on the part of either nurses or patients to participate in the study will be considered as no entry criteria.
Intervention groups
Intervention group: An educational package about the quality of nursing care before, during and after plaster casting will be provided to emergency and orthopedic nurses.
Main outcome variables
Quality of care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180523039793N1
Registration date: 2018-07-11, 1397/04/20
Registration timing: prospective

Last update: 2018-07-11, 1397/04/20
Update count: 0
Registration date
2018-07-11, 1397/04/20
Registrant information
Name
Razieh Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 7971
Email address
razieh.mokhtari91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the quality of nursing care of patients candidate for plaster casting, before and after an educational package provided to nurses
Public title
The effect of an educational package provided to nurses on the quality of nursing cares
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient with a fracture in the upper or lower extremities. The patient who is admitted to the Shahid Beheshti Hospital of Kashan University of Medical Sciences. Patient should be candidate for plaster placement for fracture management or be plastered (at least one day in hospital). Nurses with a Bachelor of Science degree who have at least six months of working experience. A nurse should work in the trauma emergency, orthopedics and surgery units in Shahid Beheshti Hospital of Kashan.
Exclusion criteria:
Lack of willingness on the part of either nurses or patients to participate in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 94
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
During the data collection, nurses would be unaware of being observed. For this reason, before data collection starts, the first researcher will be present in the research setting (in the form of student work), to normalize her presence. Then, the data collection will begin.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
The office of supervision on research projects, Research deputy, Kashan University of Medical Sciences, Ravand Road, 5th Km, kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-05-07, 1397/02/17
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1397.008

Health conditions studied

1

Description of health condition studied
Limbs fractures
ICD-10 code
M95-M99
ICD-10 code description
Other disorders of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Quality of care
Timepoint
During a one-month period before presenting the educational package, and during a one-month period after the presenting the educational package
Method of measurement
A checklist designed by the researcher.

Secondary outcomes

empty

Intervention groups

1

Description
An educational package about the care of patients with plaster casting will be provided to nurses in the form of lectures, instructional CDs, booklet and pamphlets .
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Razieh Mokhtari
Street address
Shahid Beheshti Hospital, Ravand Road
City
Kashan
Province
Isfehan
Postal code
۸۷۱۵۹۷۳۴۴۷
Phone
+98 31 5554 0029
Email
beheshtihospital@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Research deputy, Kashan University of Medical Sciences, 5th Km of Ghotbe Ravandi road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5557 5057
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Razieh Mokhtari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Science, Ravand road
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 1181
Fax
+98 31 5557 8011
Email
razieh.mokhtari91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Adib-Hajbaghery
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Trauma Nursing research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, 3th km of Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
adibhajbagheri_m@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Razieh Mokhtari
Position
Student in Master of Sciences in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Ravand road
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5562 1182
Fax
+98 31 5554 6633
Email
mokhtari-r@kaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
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
Not applicable
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