Protocol summary

Study aim
Determining the effect of principles of professional ethics counseling on compliance and applicability rate of professional ethics codes of midwifery in Midwives working in community health centers in 2018
Design
Parallel group randomized trial, not blinded
Settings and conduct
In the intervention group will be presented group counseling and in control group will be presented educational booklet related to professional midwifery ethics. The content of the sessions in the intervention group includes two sessions of training and familiarization with 85 midwifery professional ethics codes in Iran. In the next four sessions counseling will be done based on the ethics codes of the reproductive health service providers and the identification of the most important and challenging codes of any domain of education and counseling.
Participants/Inclusion and exclusion criteria
inclusion criteria: 1- Having satisfaction to participate in the study 2- Having a Bachelor or Midwifery degree 3. At least one year of work experience associated with midwifery 4. Not attending meetings or workshops related to professional ethics for at least the last six months 5. Failure to refer to the medical system and other relevant authorities for explanation of professional performance or refusal Exclusion criteria: 1. Unwillingness to continue studying 2. More than 5% defect in completing the questionnaire 3. Not attending more than one counseling session in the intervention group
Intervention groups
In the intervention group will be presented group counseling (with 6-9 people) related to professional midwifery ethics in 6 sessions /90 minutes each week, and in control group will be presented educational booklet related to professional midwifery ethics.
Main outcome variables
compliance rate of professional ethics codes of midwifery؛ applicability rate of professional ethics codes of midwifery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150209021020N2
Registration date: 2018-08-10, 1397/05/19
Registration timing: registered_while_recruiting

Last update: 2018-08-10, 1397/05/19
Update count: 0
Registration date
2018-08-10, 1397/05/19
Registrant information
Name
Zahra Mehdizadeh Tourzani
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6008
Email address
minouei@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of principles of professional ethics counseling on compliance and applicability rate of professional ethics codes of midwifery in Midwives working in community health centers in 2018
Public title
The effect of principles of professional ethics counseling on compliance and applicability rate of professional ethics codes of midwifery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the consent to participate in the study Have a Midwifery Bachelor degree or higher At least one year of work experience associated with midwifery
Exclusion criteria:
Attend to meetings or workshops related to professional ethics for at least the last six months Refer to the medical system and other relevant authorities to explain the professional performance or to refuse the charge
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
It is divided into intervention and control groups based on random allocation (quadruple random blocks).
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 Alborz University of Medical Sciences
Street address
Administrative City, North Taleghan Blvd., Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-04-28, 1397/02/08
Ethics committee reference number
IR.ABZUMS.REC.1397.010

Health conditions studied

1

Description of health condition studied
The subject is not a disease.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Compliance rate of professional ethics codes of midwifery
Timepoint
Initially, at the end and four weeks after the end of the study (counseling sessions)
Method of measurement
Questionnaire  of Code of Ethics for Reproductive Health Services Providers

2

Description
Applicability rate of professional ethics codes of midwifery
Timepoint
Initially, at the end and four weeks after the end of the study (counseling sessions)
Method of measurement
Questionnaire  of Code of Ethics for Reproductive Health Services Providers

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group counseling (with 6-9 people) related to professional midwifery ethics in 6 sessions /90 minutes each week
Category
Behavior

2

Description
Control group: ٍEducational booklet related to professional midwifery ethics
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Rast Ravesh Health Center
Full name of responsible person
Soheila Shahabnia
Street address
Vahdat Street, South Taleghani Blvd
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3270 0011
Email
s.shahabnia1395@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Nori Sepehr
Street address
Saffarian Alley, 45 meters Golshahr
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3464 3398
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Soheila Shahabnia
Position
Master's degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
The western end of the Boali, Nabovat Square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7383
Email
s.shahabnia1395@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Member of the faculty of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
The western end of the Boali, Nabovat Square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7383
Email
zahramehdizadeh_t@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zahra Mehdizadeh Tourzani
Position
Member of the faculty of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
The western end of the Boali, Nabovat Square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3428 7383
Email
Zahramehdizadeh_t@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main implications will be shared.
When the data will become available and for how long
Start the data access period, 6 months after printing the results
To whom data/document is available
All researchers working at university centers
Under which criteria data/document could be used
By referring to the reference after the publication of the article, the documentation will be usable.
From where data/document is obtainable
Send to email address: zahramehdizadeh_t@yahoo.com
What processes are involved for a request to access data/document
The email request to zahramehdizadeh_t@yahoo.com will be answered within one month.
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