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Evaluation of the effect of consultation based on Bristol tool on self-efficacy and continuation of breast- feeding among primi-parous women undergoing cesarean section.

Protocol summary

Summary
Objectives: the aim of this study is to determine the effect of consultation based on Bristol tool on self-efficacy and continuation of breast-feeding among primiparous mothers undergoing Cesarean section in Fatemieh Hospital, Hamadan city, Iran, 2017. Design: This study is an experimental study with two intervention and control groups. Participants: the study participants are 80 mothers undergoing Cesarean section. They will be selected by convenience sampling (40 in each group). The samples will be allocated into the intervention and control groups using eight block method. Setting and conduct study: Before consultation, participants will complete a consent form. Then, data will be gathered using a questionnaire including demographic characteristics, self-efficacy and continuation of breast-feeding. Intervention: for intervention group, check list of Bristol assessment tool will be completed by the researcher. Based on this assessment tool, breast-feeding consultation will be done for 4 sessions. Individual breastfeeding counseling will be conducted at two hours, second day, one week and one month after delivery. Also at first session, mothers will receive educational booklet about breastfeeding. Then follow up via telephone will be done in the 1st, 2nd, 3rd and 4th months after delivery for evaluation of mothers' breastfeeding problems. During this period, mothers in control group will receive only routine care. Four months after delivery, questionnaires will be completed again by the participant of both groups and they will be compared on self-efficacy and continuation of breast-feeding.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041810426N16
Registration date: 2017-06-13, 1396/03/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-13, 1396/03/23
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of consultation based on Bristol tool on self-efficacy and continuation of breast- feeding among primi-parous women undergoing cesarean section.
Public title
Effects of consultation based on Bristol tool on breast-feeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Cesarean section delivery; primiparous; literacy; Residency in Hamadan city; Having a mobile number for follow-ups; Singleton birth and term delivery. Exclusion criteria: Inability to do breastfeeding according to physician’s approval; Problems after cesarean section such as bleeding and anesthesia related problems; Underlying disease in mother such as cardiac, pulmonary, chronic and infection diseases; Addiction; Neonatal abnormality and diseases.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, in front of Mardom Park, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.UMSHA.REC.1396.66

Health conditions studied

1

Description of health condition studied
Breast- feeding disorders among mothers undergoing Cesarean section
ICD-10 code
O92.2
ICD-10 code description
Other and unspecified disorders of breast associated with childbirth

Primary outcomes

1

Description
Mother's self-efficacy in breastfeeding
Timepoint
2 hours after delivery, second day after delivery, 7 to 10 days after delivery, one month after delivery and four months after delivery
Method of measurement
Breastfeeding Self-Efficacy

Secondary outcomes

1

Description
Maintaining of exclusive breastfeeding
Timepoint
2 hours after delivery, second day after delivery, 7 to 10 days after delivery, one month after delivery and four months after delivery
Method of measurement
Breast-feeding checklist

Intervention groups

1

Description
Intervention: for intervention group, check list of Bristol assessment tool will be completed by the researcher. Based on this assessment tool, breast-feeding consultation will be done for 4 sessions. Individual breastfeeding counseling will be conducted at two hours, second day, one week and one month after delivery. Also at first session, mothers will receive educational booklet about breastfeeding. Then follow up via telephone will be done in the 1st, 2nd, 3rd and 4th months after delivery for evaluation of mothers' breastfeeding problems. Four months after delivery, questionnaires will be completed again by the participant of both groups and they will be compared on self-efficacy and continuation of breast-feeding.
Category
Early detection

2

Description
Control group: only will receive routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemih Hospital in Hamadan
Full name of responsible person
Raheleh Khodabandelou
Street address
Fatemieh Hospital, Pasdaran Street, Hamadan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, in front of Mardom Park, Shahid Fahmideh Street, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, in front of Mardom Park, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178-38698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, in front of Mardom Park, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, in front of Mardom Park, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.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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