Protocol summary

Summary
(1)Objectives, the present study aimed to assess the effect of Language infants cry training on neonatal crying and mother’s stress, anxiety, depression and maternal-fetal attachment(2) Design We selected 100 mothers who first visited the health centers of Semnan for the first time after delivery to receive their newborns vaccination and randomly divided into two groups: control and intervention. Setting and conduct ,This is a randomized clinical trial. participants will allocated randomly in case or control group in which 50 mothers and infants are randomly assigned to the control group in control and 50 mothers and infants. Participants will be selected from prime mothers who do not have psychological disorders and have given birth to a healthy baby(5) Intervention, and (6) main outcome measures, The both groups, Depression,Stress, Mothertochild attachment and The duration of crying baby were evaluated The first and third attending To health centers.The intervention group Training a part in 60minute Teaching crying infant and the summary of whole teaching topics in the form of note and CD in addition to receiving the On the second attending. .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201706174534N2
Registration date: 2017-07-25, 1396/05/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-25, 1396/05/03
Registrant information
Name
nahid hushmand
Name of organization / entity
Semnan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 4299
Email address
hoshmand1020@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Semnan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects Language infants cry training on The duration of crying infant and The Attachment to Infant and Mothers and in stress, Anxiety,depression prime pregnant women
Public title
The effects Language infants cry training on The duration of crying infant and The Attachment to Infant and mood prime pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria of the Primiparous Women; being 17-36 years old; having at least High school degree; singleton Newborns and not having obstetric problems ; Healthy baby and Apgar 9 or 10; and singleton pregnancy. the exclusion criteria of the study psychological disorders
Age
From 79 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
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
semnan university of Medical Sciences
Street address
semnan University of Medical Sciences and Health Services،Basij Blvd،semnan،Iran
City
Semnan
Postal code
3519899951
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.SEMUMS.REC.1396.7

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F40-F48
ICD-10 code description
Neurotic،Stress،Related and somatoform disorders

Primary outcomes

1

Description
Anxiety
Timepoint
The first and third attending
Method of measurement
Depression Anxiety and Stress Scale (DASS-21)

Secondary outcomes

1

Description
Mother-to-child attachment
Timepoint
first and third attending
Method of measurement
Avant's questionnaire

Intervention groups

1

Description
Intervention group: The intervention group Training a part in 60minute Teaching crying infant and the summary of whole teaching topics in the form of note and CD
Category
Behavior

2

Description
Control group: routine care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tadayon Health Center semnan
Full name of responsible person
Nahid Hoshmand Motlagh
Street address
semnan،Shahid Rajaee Street،Tadayon Health Center semnan
City
semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan university of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
semnan University of Medical Sciences and Health Services،Basij Blvd،semnan،Iran
City
Semnan
Grant name
اعتبارات پژوهشي دانشگاه علوم پزشكي
Grant code / Reference number
1208
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan Universiyt OF Medical Sciences
Full name of responsible person
nahid hoshmand motlagh
Position
Postgraduate
Other areas of specialty/work
Street address
Amir hospital
City
Semnan
Postal code
351973473
Phone
+98 23 3346 5721
Fax
+98 33461580
Email
Hoshmand@sem-ums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University Of Medical Sciences
Full name of responsible person
Nahid Hoshmand Motlagh
Position
Postgraduate
Other areas of specialty/work
Street address
Amir hospital
City
semnan
Postal code
351973473
Phone
+98 23 3346 5721
Fax
+98 33461580
Email
Hoshmand@sem-ums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan Universiyt OF Medical Sciences
Full name of responsible person
nahid hoshmand motlagh
Position
Postgraduate
Other areas of specialty/work
Street address
Amir hospital
City
Semnan
Postal code
351973473
Phone
+98 23 3346 5721
Fax
+98 33461580
Email
Hoshmand@sem-ums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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