The effect of volunteer’s telephone-based support on the effect of volunteers' telephone-based support on decreasing the postnatal depression
decreasing the postnatal depression
Abstract
Objectives: The aim of this research is to study the effect of volunteer’s telephone-based support on decreasing postnatal depression.
Materials and Methods: In a randomized controlled trial, the mothers fill the Edinburg Postnatal Depression Scale (EPDS) on 10-15 days after uncomplicated childbearing. After applying exclusion criteria, 54 eligible mothers with mild and moderate depression (scores= 11-14) will be allocated into intervention group 1 and group 2T randomly. the intervention group 1recieve routine postnatal health care beside telephone based support by health volunteers and will be asked and explained about their questions The intervention group 2 will use the routine postnatal health care,. A questionnaire will be used to collect demographic and contextual variables. After 6 weeks mothers will fill the EPDS and depression scores will be measured again. Data will be analyzed using chi-square test, Fisher’s exact test, t-test and paired t-test.
key words: women health, telephon based support, health volunteer, EPDS, postnatal depression
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202159027N1
Registration date:2012-04-09, 1391/01/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-09, 1391/01/21
Registrant information
Name
Hourieh Shamshiri Milani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3893
Email address
hshamshiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-04-21, 1391/02/02
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of volunteer’s telephone-based support on the effect of volunteers' telephone-based support on decreasing the postnatal depression
decreasing the postnatal depression
Public title
The effect of volunteer’s telephone-based support on the effect of telephone-based support on postnatal depression
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criterion were: term live childbirth. Exclusion criteria were: history of mental disorder; episodes of mental disorders during pregnancy or last year that necessitate medicine use; dead fetus; history of postpartum depression; current use of psychiatric prescribed drugs and the EPDS score more than 14
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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
community medicine Depatment
Street address
Velenjak, Koodakyar street, Faculty of MedicineShahid Beheshti University of Medical Sciences, Velenjak
City
Tehran
Postal code
1985734957
Approval date
2012-03-05, 1390/12/15
Ethics committee reference number
15862/308
Health conditions studied
1
Description of health condition studied
Postnatal depression
ICD-10 code
F53
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Postnatal depression
Timepoint
Before intervention and six weeks after intervention
Method of measurement
Edinburg Postnatal Deprssion Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group 1 will receive routine postpartum care plus volunteers’ telephone-based supports till 6 weeks. Eight health volunteers will be trained and every of them will cover 3-4 mothers for 2-3 times per week, telephone-based supporting. During every call after greeting, they will ask their health status, mood and relationship with their newborns and whether there is any problem? They will solve the problem according to their training guidance. They will be in close contact with the main researcher and should not talk to the other volunteers in this regard. The control group do not receive this support and only receive routine postpartum care. At the end of 6 weeks, EPDS will be filled again in two groups and the depression scores were calculated.
Category
N/A
2
Description
Interventeion group 2: The intervention group two will receive only routine postnatal care and have the same characteristic as intervention group one.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
the hospitals of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hourieh Shamshiri Milani
Street address
Velenjak- Daneshjoo Blvd. Koodakyar Ave. Faculty of Medicine, 8th floor, Department of Community Medicine
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Reaserch, Faculty of Medicnie, Shahid Beheshti University of Medica
Full name of responsible person
Dr. Houssein Ghoodarzi
Street address
Velenjak- Daneshjoo Blvd. Koodakyar Ave. Faculty of Medicine, 8th floor, Department of Community Medicine
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Reaserch, Faculty of Medicnie, Shahid Beheshti University of Medica
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hourieh Shamshiri Milani
Position
Obstetrician & Gynecologist- MPH, Assistant Professor
Other areas of specialty/work
Street address
Velenjak- Daneshjoo Blvd. Koodakyar Ave. Faculty of Medicine, 8th floor, Department of Community Medicine
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 9936
Fax
+98 21 2243 9936
Email
hshamshiri@sbmu.ac.irhourieh_milani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hourieh Shamshiri Milani
Position
Obstetrician & Gynecologist , MPH ,
Other areas of specialty/work
Street address
Velenjak, Daenshjoo BLvd. Koodakyar Ave. Faculty of Medicine, 8th floor, Department of Community Medicine
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 9936
Fax
+98 21 2243 9936
Email
hshamshiri@sbmu.ac.irhourieh_milani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hourieh Shamshiri Milani
Position
Obstetrician & Gynecologist, MPH ; Assistant Professor
Other areas of specialty/work
Street address
Velenjak- Daneshjoo Blvd. Koodakyar Ave. Faculty of Medicine, 8th floor, Department of Community Medicine
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 9936
Fax
+98 21 2243 9936
Email
hshamshiri@sbmu.ac.irhourieh_milani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)