To Determine The Effect of Telephone Supportive Counseling In Improving of The Breastfeeding Self-efficacy of Mothers With Preterm Infant 34-36 Weeks
Design
Phase 3 of A Randomized Clinical Trial With A Control Group, With Parallel Groups, Will be Conducted On 65 Patients. Samples Will be Selected Using The Convenience Sampling Method and Then Will be Assigned To Two Intervention And Control Groups Using The Four Block Random Method. In This Study, We Do not Have Blinding. The Outcome of The Study is Breastfeeding Self-efficacy, Which Will be Measured Using The Dennis Breastfeeding Self-efficacy Questionnaire Before Counseling And Then Monthly Up To Four Months After Counseling.
Settings and conduct
In The Present Study, The Research Setting is Sina Hospital of Ahvaz And The Research Community is Mothers With Premature Infants Admitted To The Hospital. Consultation Sessions Will be Held At The Hospital. Telephone Support Counseling Will be Receive Individually, Daily For 14 Days From The Time of Discharged. Control Group will be received Routine Training During The Discharge.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Informed Consent to Participate in The Research; Gestational Age 34-37 Weeks; Infant Feeding With Mother's Breast. Exclusion Criteria: Intrauterine Growth Retardation; Congenital Disease.
Intervention groups
The Intervention Group, Telephone Support Counseling will be Receive Individually, Daily For 14 Days From The Time of Discharged.
In The Control Group, Routine Training will be Given During The Discharge.
Main outcome variables
Breastfeeding Self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150731023423N13
Registration date:2020-05-17, 1399/02/28
Registration timing:prospective
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Telephone Supportive Counseling in Improving The Breastfeeding Self-efficacy of Mothers with Preterm Infant 34-36 Weeks
Public title
The Effect of Telephone Supportive Counseling in The Breastfeeding Self-efficacy of Mothers with Preterm Infant 34-36 Weeks
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational Age 34-37 Weeks
Informed Consent to Participate in Research
At Least 48 Hours Hospitalization in The Neonatal Intensive Care Unit
Infant Feeding From The Mother's Breast
Convenience Sampling Method Was Employed to Select The Eligible Mothers and They Were Allocated Into Two Groups (Intervention and Control) According to The Four Block Design. In This Way, Six Possible Blocks Were Assigned to Groups A (Intervention) and B (Control) . Then, The Number of Blocks Was Selected From The Random Number Table Until The Study Sample Size Was Reached. To Ensure The Concealment of The Sequence of Enrollment, We Used The Sequentially Numbered, Opaque Sealed Envelopes.
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 Zanjan University of Medical Sciences
Street address
Zanjan, Azadi Blvd., Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.ZUMS.REC.1398.240
Health conditions studied
1
Description of health condition studied
Breastfeeding Self-efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Breastfeeding Self-efficacy
Timepoint
After Discharge And Monthly Up To Four Month
Method of measurement
Dennis Breastfeeding Self-Efficacy Questionnaire
Secondary outcomes
1
Description
Breastfeeding Self-efficacy
Timepoint
After Discharge And Monthly Up To Four Month
Method of measurement
Dennis Breastfeeding Self-Efficacy Questionnaire
2
Description
Breastfeeding Level
Timepoint
After Discharge And Monthly Up To Four Month
Method of measurement
A Question With Three Levels, Exclusive Breastfeeding, Combined Nutrition (Exclusive Nutrition And Bottle), Bottle
Intervention groups
1
Description
The Intervention Group Includes Eligible Women With Premature Infants Hospitalized In The Neonatal Intensive Care Unit Who Will be Received Individuality Telephone Supportive Counseling Daily For 14 Days After Discharge . How To Care of Her Baby And Breastfeeding Problems Will be educated To Mothers.
Category
Prevention
2
Description
Control group: The Control Group Also Has Eligible Women With Premature Infants And Will be Only Received Discharge Training .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Haspital Sina,Abuzar,Imam Khomeini Ahvaz
Full name of responsible person
Marziyeh Mohammadiyan
Street address
Imam Khomeini Street, Sina Haspital, Ahwaz, Iran
City
Ahwaz
Province
Khouzestan
Postal code
6184734531
Phone
+98 61 3555 0593
Email
mohammadiyanmarziyeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan, Azadi Blvd., Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3524 2075
Email
mohammadiyanmarziyeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Lack of funding
Proportion provided by this source
1
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
Zanjan University of Medical Sciences
Full name of responsible person
Marziyeh Mohammadiyan
Position
Master of Degree Student in Midwifery Counseling
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
5614844753
Phone
+98 45 3345 1618
Email
mohammadiyanmarziyeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Azam.Maleki
Position
PhD in Maternal & Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Email
Makekia@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Azam.Maleki
Position
PhD in Maternal & Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Email
Makekia@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Maintaining Confidentiality And The Possibility of Customer Dissatisfaction