The aim of this randomized controlled trial is to determine the effects of telephone counseling on exclusive breastfeeding and postpartum depression. After signing an informed consent form, 366 eligible mothers will complete a questionnaire about demographic and reproductive characteristics in postpartum ward of Akbarabadi Hospital in Tehran. These persons will be randomly assigned into intervention or control group with 1:2 assignment ratio. For group assignment, we will use permuted block randomization with block sizes of 3 and 6 concealed in sequentially numbered, sealed, opaque envelops. Research team will have no contact with the subjects in the control group and they only receive postpartum care from the health centers. While, subjects in the intervention group will get telephone counseling, in addition to the routine postpartum care from the centers. The first telephone counseling will be within 48 hours after hospital discharge. Next, there will be telephone contacts 2 times in the first week and once a week in 2-6 weeks. Each counseling will take about 20 minutes. Counselor is a midwifery Master of Science student with special short-term training in postpartum care. The subjects in intervention group can also contact with the counselor by telephone. An assistant, non-aware of the group assignment, will collect the final data about child nutrition and mental health of the mothers from the participants within 60-66 days postpartum at the hospital.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105093706N6
Registration date:2011-07-02, 1390/04/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-02, 1390/04/11
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2011-07-21, 1390/04/30
Expected recruitment end date
2011-11-21, 1390/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of telephone counseling on exclusive breast feeding and postpartum depression: A randomized controlled trial.
Public title
Effect of telephone counseling on exclusive breastfeeding and postpartum depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: being resident of Tehran; married; education more than six years; willing to have exclusive breastfeeding; giving birth to a single healthy baby with Apgar score of 7 or more in the fifth minute; easy access by telephone; no problem in speech and hearing; not suffering from chronic disorders (diabetes, hypertension, thyroid disorders, asthma, or any other diseases) requiring prescription of drug (based on individual’s record); no history of mental disorders requiring drug use including postpartum depression; not being smoker or drug user and no history of still birth or child death.
Exclusion criteria: No mother or newborn discharge within 72 hours after delivery and occurrence of an important emotional event like death of near relatives during the study period
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
366
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Contents of the telephone counseling will be based on national, WHO, and other valid organizations guidelines. Each counseling has two parts: first, the counselor will ask the mother about their problems experienced during previous week and will note them in the checklist. Then counseling will be done about the problems. The second part of the counseling will be about support of exclusive breastfeeding and general recommendations for prevention of postpartum depression. Consultation with other persons like relatives of the mother or referring to specialty centers will be done, if necessary.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences, Reaserch deputy
Street address
Tabriz-Golgasht street-Tabriz University of Medical Sciences-Building 2 - Floor 3 - Field Research
City
Tabriz
Postal code
11851665
Approval date
2011-06-14, 1390/03/24
Ethics committee reference number
912
Health conditions studied
1
Description of health condition studied
Postpartum depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
2
Description of health condition studied
Exclusive breastfeeding
ICD-10 code
P92
ICD-10 code description
Feeding problems of newborn
Primary outcomes
1
Description
Exclusive breast-feeding during the last 24 hours
Timepoint
Once in 60 to 66th days postpartum
Method of measurement
Asking the question
Secondary outcomes
1
Description
Postpartum depression scores
Timepoint
Once in 60-66th day after delivery
Method of measurement
Using 10 questions Edinburgh scale
2
Description
How to receive preventive and curative care from public and private centers
Timepoint
During 6 weeks postpartum
Method of measurement
Self-administered form
Intervention groups
1
Description
Intervention group: Regular counseling by telephone. The first counseling will be within 48 hours after hospital discharge. Next, there will be telephone contacts 2 times in the first week and once a week in 2-6 weeks. Each counseling will take about 20 minutes, which can vary upon requirement. Each session has two parts: first, the counselor will ask the mother about their problems experienced during previous week and will note them in the checklist. Then counseling will be done about the problems. The second part of the counseling will be about support of exclusive breastfeeding and general recommendations for prevention of postpartum depression. Counselor is a midwifery Master of Science student with special short-term training in postpartum care. The subjects in intervention group can also contact with the counselor by telephone. Both groups can receive routine care from the health centers (three times in the 6 weeks)
Category
Lifestyle
2
Description
Control group: no intervention by the research team Both groups can receive routine care from the health centers (three times in the 6 weeks)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Nafiseh Shokranian
Street address
Molavi Street, Station Garden Ferdows, Akbar-Abadi Maternity Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Third floor, Building number2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shokranian Nafiseh
Position
Midwifery graduate student
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati
City
Tabriz
Postal code
Phone
+98 21 6669 2439
Fax
Email
shokraniannafiseh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Assistant professor, PhD in reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1479 0364
Fax
Email
alizades@tbzmed.ac.ir; smoalch@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Midwifery graduate student
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
Email
alizades@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)