Protocol summary

Study aim
Determining the Effectiveness of Teaching Communication Skills to Midwives on Anxiety in Primiparous Women
Design
The present study was a non-randomized clinical trial in two groups including case group, midwives working in Bahar Shahroud Hospital and control group, midwives working in Velayat Damghan Hospital . In this research, intervention was conducted on midwives and indirectly its effect on the anxiety of mothers Is measured. The intervention included the holding of communication skills workshop for midwives
Settings and conduct
The place of data collection in this study is the delivery department of Bahar Shahroud Hospital and Velayat Damghan Hospital.
Participants/Inclusion and exclusion criteria
Entrance criteria for midwives: 1. Having a midwifery degree (bachelor &master's degree) 2. Having at least one year of work experience Exit criteria: History of participation in patient communication skills training workshops
Intervention groups
Communication skills workshop for midwives intervention in the form of group discussion, questions and answers, speaking and acting for two days a week, the time is about 4 hours each session will be held. The number of people in each session depending on the number of midwives is about 15 people. A month after the workshops, communication skills midwives measured using questionnaires. In the control group not held a workshop for midwives.
Main outcome variables
The primary outcome anxiety level, which is measured by the Spielberger questionnaire . Secondary outcomes to evaluate the communication skills of midwives, which is measured by a questionnaire Queendom communication skills. The third consequence of the behavior of midwives maternal satisfaction, which is measured by the satisfaction questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180126038512N1
Registration date: 2018-07-19, 1397/04/28
Registration timing: retrospective

Last update: 2018-07-19, 1397/04/28
Update count: 0
Registration date
2018-07-19, 1397/04/28
Registrant information
Name
Maryam Baradaran firoozabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
baradaran.m@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-06-19, 1397/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of communication skills training on Midwives on Anxiety in primiparous women
Public title
The Effect of Teaching Communication Skills on Midwives on Anxiety of mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a Degree in Midwifery(Bachelor &master's degree) Having at least one year of work experience
Exclusion criteria:
History of participation in patient communication skills training workshops
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Not 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 Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences,Hafte Tir Square,Shahroud
City
Shahrud
Province
Semnan
Postal code
361763855
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.SHMU.REC.1396.158

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F30-F39
ICD-10 code description
Mood [affective] disorders

Primary outcomes

1

Description
Anxiety
Timepoint
During the three stages, at the onset, the first stage of labor and two hours after delivery
Method of measurement
Spielberger Anxiety Inventory

2

Description
satisfaction
Timepoint
Two hours after childbirth
Method of measurement
Researcher-made questionnaire on satisfaction with midwife's behavior and performance

Secondary outcomes

1

Description
Satisfaction
Timepoint
Two hours after delivery
Method of measurement
Researcher-made questionnaire on satisfaction with midwife's behavior and performance

Intervention groups

1

Description
Intervention group: Firstly, the communication skills of midwives working in Bahar Hospital are measured by questionnaires. Then, for midwives, intervention is conducted as a communication skills training workshop and one month after the completion of the workshop, midwifery communication skills are assessed by questionnaires.
Category
Behavior

2

Description
Control group: midwives working in Damghan Hospital as a control group, who are only assessed by their questionnaire, their communication skills and did not receive training.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahar Hospital
Full name of responsible person
Maryam Baradaran Firooz Abadi
Street address
Bahar Hospital,Opposite to Koodak,22Bahman St..,Shahroud
City
Shahroud
Province
Semnan
Postal code
3617638555
Phone
+98 23 3239 1796
Email
baradaran25468@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryambaradaran Firoozabadi
Street address
Central building of Shahroud University of Medical Sciences,Hafte Tir Square,Shahroud
City
Sahroud
Province
Semnan
Postal code
3617638555
Phone
+98 23 3239 4063
Email
baradaran25468@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Maryam baradaran Firoozabadi
Position
Student of Midwifery Conseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Central building of Shahroud University of Meddical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3617638555
Phone
+98 23 3239 4063
Email
baradaran25468@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Nahid Bolbol haghighi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Central building of Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3617638555
Phone
+98 23 3239 4063
Email
nbhaghighi349@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam baradaran Firooz abadi
Position
Student of Midwifery Conseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Central building of Shahroud University of Medical Sciences, Haft Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
3617638555
Phone
+98 23 3239 4063
Email
baradaran25468@gmail.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Access to protocol abstract
When the data will become available and for how long
Start the access period one year after the print results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only for researchers working in academic and scientific institutions
From where data/document is obtainable
by Email
What processes are involved for a request to access data/document
Visit Shahroud University of Medical Sciences website
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