Protocol summary

Summary
Objectives: Stress management on pregnant women during the first trimester. Design: This project is a clinical trial with pre-test and post- test. This is a pilot study, The sampling is convenient.The subjects are pregnant women whose stress level will be measured by Hamilton inventory and Spielberger state anxiety inventory. We will have two groups, intervention group(n=25) with moderate stress level and control group (n=25) with mild stress level. Only intervention group will be trained with psychological interventions. Both groups receive usual prenatal care. Setting and conduct: They will be trained the stress management techniques in 5 sessions by psychologist, every session will be 60 minute. After training, Their stress level will be measured by Hamilton inventory and Spielberger state anxiety inventory again. All group members will be received usual prenatal care. we will check preterm labor, preeclampsia during pregnancy; in addition, we will check bilateral uterine artery doppler before and after intervention; then, we will compare them with themselves, besides we will measure infant's weight ,height and hospitalization rate in NICU, moreover we will check the admission rate in high risk ward for icter in neonates. Participants including major eligibility criteria: Gestational age<14w; Education=High school degree and upper; 25.4 ≥BMI ≥19.3; 37 ≥Maternal age≥19; Having informed consent. Exclusion criteria: Having psychological disorders such as depression, psychos, cognitive disorder and drug abuse. History of any medical disease such as Thyroid disease, Cardiac disease, Hepatic disease, Chronic renal disease; BMI<19 or BMI>25.3; Abortion>2; Poor pregnancy history such as IUFD. Intervention: Training stress management techniques in five sessions, every session is 60 minutes. Some of mindfulness and cognitive techniques are used for training them. main outcome variables: Management stress

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013081814174N2
Registration date: 2013-12-20, 1392/09/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Mohamad Naser Jalalian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8869 8556
Email address
shirazim@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of psychological intervention on pregnancy outcomes and stress reduction in pregnant women during the 1st trimester at General Women Hospital
Public title
Stress managament on pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age<14w; Education=High school degree and upper; 25.4 ≥BMI ≥19.3; 37 ≥Maternal age≥19;Having informed consent. Exclusion criteria: Having psychological disorders such as depression, psychos, cognitive disorder and drug abuse. History of any medical disease such as Thyroid disease, Cardiac disease, Hepatic disease,Chronic renal disease; BMI<19 or BMI>25.3; Abortion>2; Poor pregnancy history such as IUFD.
Age
From 19 years old to 37 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
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
Ethics Committee,Tehran University of Medical Sciences
Street address
No 21, Qods St, Keshavarz Blvd, Tehran.
City
Tehran
Postal code
1417653761
Approval date
2013-07-10, 1392/04/19
Ethics committee reference number
88593

Health conditions studied

1

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

Primary outcomes

1

Description
Stress management
Timepoint
Measuring the level of stress before and after Intervention
Method of measurement
Hamilton inventory, Spielberger state anxiety inventory

Secondary outcomes

1

Description
Infant's height & weight.
Timepoint
After Delivery
Method of measurement
We will measure infant's weight and height.

2

Description
Measuring bilateral uterine artery
Timepoint
Before and after intervention sessions
Method of measurement
Sonography

3

Description
preeclampsia
Timepoint
During of pregnancy
Method of measurement
control of blood pressure in prenatal care

4

Description
Preterm labour
Timepoint
After intervention, during of pregnancy
Method of measurement
Prenatal care

5

Description
Hospitalization rate in NICU.
Timepoint
After Delivery.
Method of measurement
Controlling hospitalization rate in NICU after delivery.

Intervention groups

1

Description
Intervention: Training stress managament techniques in five sessions, evrey session is 60 minute.some of mindfulness and cognitive techniques use for training them.
Category
Prevention

2

Description
Control: NO treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
General Hospital Women
Full name of responsible person
Dr Mahboobeh Shirazy
Street address
Ostad Njatollahi Av, Karim khan St, Tehran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr Mahboobeh Shirazy
Street address
North of Ostad Njatollahi Av, Karim khan St, Tehran
City
Tehran
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,Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maasoomeh Mohseni Kabir
Position
MS student
Other areas of specialty/work
Street address
No 21, Qods St, Keshavarz Blvd, Tehran.
City
Tehran
Postal code
1417653761
Phone
+98 21 8897 6980
Fax
Email
mmkmohseni@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Mohseni Kabir
Position
MS student
Other areas of specialty/work
Street address
No 21, Qods St, Keshavarz Blvd, Tehran.
City
Tehran
Postal code
1417653761
Phone
+98 218897980
Fax
Email
mmkmohseni@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maasoomeh Mohseni Kabir
Position
MS student
Other areas of specialty/work
Street address
No 21, Qods St, Keshavarz Blvd, Tehran.
City
Tehran
Postal code
1417653761
Phone
+98 21 8897 6980
Fax
Email
mmkmohseni@gmail.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
empty
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