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Maternal mood disorder and its effects on infant sleep And effect of behavioral and educational interventions on maternal and infant sleep

Protocol summary

Summary
Depression during pregnancy and after childbirth, this is causing negative effects on the infant. This is a case-control. The aim of this study was to investigate the effects of mood and anxiety disorders during pregnancy on infant sleep and behavioral and educational interventions impact on maternal and infant is sleeping. This study is conducted in two stages. At the First stage 200 women will be selected in Vali Asr Hospital and Milad Hospital. Mothers will be selected without a history of recurrent miscarriage, infertility treatment, drug or mental problems or insomnia, chronic renal failure, cardiac, hepatic, gastrointestinal, or other chronic disorders, problem-free delivery and a healthy baby. 3 times in the first quarter, the second and third trimester of pregnancy and six weeks postpartum also filled STAY anxiety and Beck depression Test. Six weeks and three months of pregnancy Pittsburgh sleep quality questionnaire completed by the mother and will also be evaluated infant sleep position. In the second phase, 44 women will be selected voluntarily.The subjects will randomly divide into two groups and the control. In the intervention group a 45-minute intervention sessions to provide information on sleep structure and strategies. Mothers in the control group, is talking about sleep hygiene only 10 minutes. The result of study assumes that lead to improved health, physical, mental, cognitive and emotional well being of babies sleep .

General information

Acronym
Mood and anxiety disorders during pregnancy on infant sleep
IRCT registration information
IRCT registration number: IRCT2012091710746N2
Registration date: 2013-02-04, 1391/11/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-02-04, 1391/11/16
Registrant information
Name
Nasrin Abedinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
abedinia@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Tehran University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Maternal mood disorder and its effects on infant sleep And effect of behavioral and educational interventions on maternal and infant sleep
Public title
Maternal mood disorder and its effects on infant sleep And effect of behavioral and educational interventions on maternal and infant sleep
Purpose
Prevention
Inclusion/Exclusion criteria
The study included women who are pregnant for the first time; they do not have history of recurrent miscarriage, infertility treatment, medication or hospitalization due to mental health problems or have insomnia; no chronic kidney disease, heart, liver, stomach and other chronic disorders; no problem with the delivery and having healthy baby and not any pregnancy complications such as gestational diabetes, pre eclampsia, premature delivery; there are not any fetal problems that lead to emergency cesarean delivery, otherwise the baby is healthy, and also there are not low birth weight or Apgar score with abnormal any chronic disease neonatal in infants.
Age
From 20 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
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

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Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Ghods Avenu, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2013-01-14, 1391/10/25
Ethics committee reference number
91-04-91-20330

Health conditions studied

1

Description of health condition studied
Mood disorder
ICD-10 code
F39
ICD-10 code description
Unspecified mood [affective] disorder

2

Description of health condition studied
Anxiety disorder
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Effect on maternal sleep.
Timepoint
Postpartum and 6 months after delivery
Method of measurement
1- Edinburg 2- Beck 3- STAI 4-Pittsburgh Sleep Quality Index

2

Description
Effect on infant sleeping
Timepoint
Postpartum and 6 months after delivery
Method of measurement
Questionnaire of researcher making

Secondary outcomes

1

Description
Treatment of Depression
Timepoint
6 months after delivery
Method of measurement
1- edinburg test 2- Beck Inventory

2

Description
Treatment of anxiety
Timepoint
6 months after delivery
Method of measurement
STAY test

Intervention groups

1

Description
That includes a 45-minute meeting to provide information about the structure and strategy of sleep Including maternal sleep hygiene strategies to improve maternal sleep, deep breathing and relaxation techniques, and information on the baby sleep. This manual can be read at home. In the first week to the fifth week to provide information and offer solutions to call with persons about individual problems. Mothers in the control group, only 10 minutes of sleep hygiene and 2 phone calls in weeks 3 and 5 to make contact with the group for final review. The phone does not do any advice if you have any questions will be answered.
Category
Behavior

2

Description
In the control group, only 10 minutes of sleep hygiene mother and two telephone calls at weeks 3 and 5 to make contact with the group for final review will be conducted. The phone does not do any advice you have any questions will be answered.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Milad Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Tehran University of Medical Sciences - Research Center for Maternal Fetal Infan
Full name of responsible person
Mamak Shariat
Street address
Research Center for Maternal Fetal Infant
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tehran University of Medical Sciences - Research Center for Maternal Fetal Infan
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
Research Center for Maternal Fetal Infant
Full name of responsible person
Nasrin Abedinia
Position
MSc Clinical psychologist
Other areas of specialty/work
Street address
Vali Asr Hospital
City
Tehran
Postal code
Phone
+98 21 6119 2357
Fax
Email
nasrin_abedinia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Center for Maternal Fetal Infant
Full name of responsible person
Nasrin Abedinia
Position
MSc clinical psychologist
Other areas of specialty/work
Street address
Vali asr Hospital
City
Tehran
Postal code
Phone
+98 21 6119 2357
Fax
Email
nasrin.abedinia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research Center for Maternal Fetal Infant
Full name of responsible person
Nasrin Abedinia
Position
Master of science
Other areas of specialty/work
Street address
Maternal fetal neonatal health research center, Vali asr hospital
City
Tehran
Postal code
14192
Phone
+98 21 6119 2357
Fax
+98 21 6659 1315
Email
nasrin.abedinia@yahoo.com
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
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