Protocol summary

Summary
The main objective is the impact of communication skills training health staff on lactation. Inclusion and exclusion will at least 18 years old primigravida; she will be decide to breastfeed; had no systemic disease and no history of pregnancy with postpartum psychosis. In case of any condition or deficiency in mothers of newborn infants during the visit or any disease of the newborn or the mother will affect her ability to breastfeed will be excluded. 170 mothers are randomized into two groups (85 interventions and 85 controls). Random assignment will be performed using a permutation by randomization table. They will be selected of two even numbers in the intervention and control groups, odd numbers of mothers enter in the intervention and control groups. Mode, frequency, timing, duration of breastfeeding, time, type of complementary foods, and the use of artificial milk in the first week and two times a week, once a week from the third to the sixth, seventh and eighth week and once and at the third, fourth, fifth and sixth once (once per month) 9 times with for follow-up Mothers will be questioned by telephone. Interventions include the communication skills of health personnel trained by psychologists at the third meeting and prepared a training package and then discharge the patient mothers will be performed satisfaction questionnaire in relationship with staff.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020510746N4
Registration date: 2014-02-21, 1392/12/02
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-02-21, 1392/12/02
Registrant information
Name
Nasrin Abedinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
abedinia@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Tehran University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of communication skills training health staff on breastfeeding
Public title
The impact of communication skills training health staff on breastfeeding
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: all mothers have age 18-42 years old and are nulliparous. After signing informed consent, the mothers will be participated in case of the absence of any disease or defects in newborn infants. Exclusion criteria: none of the any samples are history of systemic diseases during pregnancy and postpartum psychosis. During a week to do precise examination if there is any disease of the newborn or the mother's ability to breastfeed she will be excluded from the study.
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 170
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods St., Keshavarz Blvd Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
22835

Health conditions studied

1

Description of health condition studied
Normal Vaginal Delivery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Increase breastfeeding
Timepoint
6 months after delivery
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Effeciency relation staff with mothers
Timepoint
After discharge
Method of measurement
Questionnaire

Intervention groups

1

Description
After selecting the group in the intervention group in 3 sessions of life skills including anger management, effective communication to staff and medical staff will be educated by a psychologist. A training package has been prepared in connection with related skills and anger control and stress for the medical staff. Behavioral actions of these individuals will be considered with mothers of babies born. Then after discharge satisfaction questionnaire will be performed by mothers, and to access the satisfaction of mothers. Mode, frequency, timing, duration of breastfeeding, time, type of complementary foods, and the use of artificial milk in the first week and two times a week, once a week from the third to the sixth, seventh and eighth week and once and at the third, fourth, fifth and sixth once (once per month) 9 times with for follow-up mothers will be questioned by telephone.
Category
Behavior

2

Description
Routine procedure is performed in the control group; then after discharge satisfaction questionnaire will be completed by mothers, and to access the satisfaction of mothers. Mode, frequency, timing, duration of breastfeeding, time, type of complementary foods, and the use of artificial milk in the first week and two times a week, once a week from the third to the sixth, seventh and eighth week and once And at the third, fourth, fifth and sixth once (once per month) 9 times with for follow-up Mothers will be questioned by telephone.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Hospital, Imam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Tehran University of Medical Sciences
Full name of responsible person
Mamak Shariat
Street address
Qods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tehran 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
Maternal Fetal and Neonatal Research Center
Full name of responsible person
Nasrin Abedinia
Position
MSc/ Researcher
Other areas of specialty/work
Street address
Vali Asr Hospital, Imam Khomeini Hospital, Maternal Fetal and Neonatal Research Center
City
Tehran
Postal code
Phone
+98 21 6119 2357
Fax
Email
nasrin.abedinia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Maternal Fetal and Neonatal Research Center
Full name of responsible person
Nasrin Abedinia
Position
MSc
Other areas of specialty/work
Street address
Asr Hospital, Imam Khomeini Hospital Maternal Fetal and Neonatal Research Center
City
Tehran
Postal code
Phone
+98 21 6119 2357
Fax
Email
nasrin.abedinia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal Fetal and Neonatal Research Center
Full name of responsible person
Nasrin Abedinia
Position
MSc
Other areas of specialty/work
Street address
Vali Asr Hospital, Imam Khomeini Hospital, Maternal Fetal and Neonatal Research Center
City
Tehran
Postal code
Phone
+98 21 6119 2357
Fax
Email
nasrin.abedinia@yahoo.com
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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