The effect of lifestyle-based education to women and their husbands on the anxiety and depression during pregnancy and postpartum: a randomized controlled trial
This randomized controlled trial aims to determine the effect of lifestyle-based education to women and their husbands on anxiety and depression during pregnancy and postpartum. 189 pregnant women at gestational age of 24 to 28 weeks with depression score less than 12 in the Edinburgh Inventory will be selected from public health centers of Bookan, Iran and will be randomly assigned into 3 groups of 63 people with a block size of 3, 6 and 9. Sequentially numbered sealed opaque envelopes will be used to conceal the allocation sequence. Interventions: Group 1: lifestyle-based education for the women and their husbands, Group 2: lifestyle-based education for only women, and Group 3: routine care. The women in the interventional groups will attend the educational classes once a week for four first weeks after recruitment. The main outcomes are depression and anxiety 8 weeks after intervention and 6 weeks postpartum which will be assessed using Edinburg inventory and Spielberger's State-Trait Anxiety Inventory, respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410113706N23
Registration date:2014-12-12, 1393/09/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-12, 1393/09/21
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
Research Deputy, Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-20, 1393/09/29
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lifestyle-based education to women and their husbands on the anxiety and depression during pregnancy and postpartum: a randomized controlled trial
Public title
The effect of lifestyle-based education to women and their husbands on the anxiety and depression during pregnancy and postpartum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: gestational age of 24 to 28 weeks; singleton pregnancy; first or second pregnancy, having a care record at one of the public health centers in Bookan, Iran; no participation in other similar studies; having a phone number for follow up; willingness to participate in the study.
Exclusion criteria: high risk for preterm birth; a history of depression or history of hospital admission due to psychiatric problems; suffering from depression (the Edinburgh Inventory score>12); addiction or habitual use of alcohol and drugs by the woman or her spouse; having a history of infertility and assisted reproductive technology; participation in childbirth preparation classes; having any chronic diseases (such as diabetes and ... ); occurrence of death of first degree relatives; divorce or other serious emotional problems in the past month.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
189
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 Tabriz University of Medical Sciences
Street address
Research Deputy, 3rd floor, Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht st., Tabriz, Iran
City
Tabriz
Postal code
Approval date
2014-11-10, 1393/08/19
Ethics committee reference number
93124
Health conditions studied
1
Description of health condition studied
Pregnancy- related psychiatric disorders
ICD-10 code
O26.9
ICD-10 code description
Pregnancy-related condition, unspecified
Primary outcomes
1
Description
Depression
Timepoint
8 weeks after intervention (32-36 weeks of pregnancy) and 6 weeks post-partum
Method of measurement
Edinburgh Inventory scale
2
Description
Anxiety
Timepoint
8 weeks after intervention (32-36 weeks of pregnancy) and 6 weeks post-partum
Method of measurement
Spielberger's State-Trait Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: lifestyle-based education (on nutrition, exercise, sleep health, and sexual health) for the women and their husbands; including four 60-90 minutes group education sessions in four consecutive weeks held by a midwife and giving an educational booklet to women in the first session to be read by them and their husbands, two educational group sessions for their husbands held by a male psychiatrist, active telephone counselling with the women and passive telephone counselling with their husbands
Category
Prevention
2
Description
Group 2: lifestyle-based education (on nutrition, exercise, sleep health, and sexual health) for only the women; including four 60-90 minutes group education sessions in four consecutive weeks held by a midwife and giving an educational booklet to the women in the first session to be read by them and their husbands, telephone counselling with the women
Category
Treatment - Drugs
3
Description
Group 3: Only routine care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Public Health Centers of Bookan
Full name of responsible person
Foziye Sanaati
Street address
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Research Deputy, 3rd floor,Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht st., Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of 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, Nursing & Midwifery Faculty
Full name of responsible person
Foziye Sanaati
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3417 4914
Fax
Email
sanaati.favziye@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science, Nursing & Midwifery Faculty
Full name of responsible person
Sakineh Mohammad-Alizadeh Charandabi
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery , South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
Alizades@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Sakineh Mohammad-Alizadeh Charandabi
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
Alizades@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)