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Clinical trial comparing the effectiveness of desensitization integration in preparation for childbirth classes to pregnant women anxiety that participate in regular classes in preparation for childbirth

Protocol summary

Summary
The aim of this study was to evaluate the effectiveness of the integration of systematic desensitization of anxiety in pregnant women for childbirth preparation classes. This study, consultation on 76 patients (38 patients per group) of nulliparous mothers attending antenatal classes 22Bahman Hospital in the city Gonabad20th week of pregnancy will be done. This randomized study with a control group without blinding done. How to target qualified individuals and how the study will be explained. The four blocks are divided in two groups and the informed consent form is completed. Inclusion criteria consisted of: Causing the first being about 20 weeks gestational age, age between 20 and 35 years, the same anxiety (STAL score of 20 to 69 in Scale anxiety, including anxiety is mild to moderately severe), lack of medical-surgical diseases ( Blood pressure, diabetes),No history of psychiatric or mental illness, and the normal healthy fetus in the first trimester graphic examination (without any fetal abnormalities, the normal location of the placenta, normal cervical length)،No apparent obstacles for normal delivery at the time of sampling, any contraindications to vaginal delivery, having the symptoms of threatened abortion, have at least read and write, singleton pregnancy, non-smoking, drugs and alcohol, single spouse, Lack of recurrent miscarriage and infertility. Exclusion criteria: absence of more than two sessions, moved, and the unavailability of pregnant women and pregnancy termination for any reason before the end of counseling, the creation of any indication for cesarean delivery. The sample size for each group of 30 is estimated. Including 20 percent chance of attrition number of samples in each group of 38 people considered to be. In addition to participating in the intervention group mothers in childbirth preparation classes for eight sessions is that desensitization techniques used in the class also will (That include relaxation training in first 4 sessions are completely if the mother is unable to properly use this approach to the next stage And the last four sessions that are related to desensitization techniques). Control group will attend classes in preparation for childbirth. Desensitization sessions in the intervention group for subgroups will be 4 to 6 persons. This parallel sessions and will integrate in its class content done. Finally, using the Spielberger anxiety in two groups compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016060428240N1
Registration date: 2016-06-16, 1395/03/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Fatemeh Yaghoobi Moghadam Bilondi
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 4499
Email address
yaghoobi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences Shahrood
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effectiveness of desensitization integration in preparation for childbirth classes to pregnant women anxiety that participate in regular classes in preparation for childbirth
Public title
Antenatal classes on pregnancy anxiety, desensitization integration in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria consisted of: Causing the first being about 20 weeks gestational age, age between 20 and 35 years, the same anxiety (Business forget of 20 to 69 in Scale anxiety, including anxiety is mild to moderately severe), lack of medical-surgical diseases ( Blood pressure, diabetes),No history of psychiatric or mental illness, and the normal healthy fetus in the first trimester graphic examination (without any fetal abnormalities, the normal location of the placenta, normal cervical length)،No apparent obstacles for normal delivery at the time of sampling, any contraindications to vaginal delivery, having the symptoms of threatened abortion, have at least read and write, singleton pregnancy, non-smoking, drugs and alcohol, single spouse, Lack of recurrent miscarriage and infertility. Exclusion criteria: absence of more than two sessions, moved, and the unavailability of pregnant women and pregnancy termination for any reason before the end of counseling, the creation of any indication for cesarean delivery.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 76
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

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences anymore
Street address
Central building of Shahroud University of Medical Sciences, "Tir" Square,Shahroud،Semnan.
City
Shahroud
Postal code
3614773955
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
IR.SHMU.REC.1395.17

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
f41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention، 4 months after treatment
Method of measurement
Spielberger questionnaire

Secondary outcomes

1

Description
Behavior change
Timepoint
Before intervention،Delivery time
Method of measurement
Information delivery

Intervention groups

1

Description
In the intervention group, in addition to previous training in preparation for childbirth classes given Desensitization in the course of the fifth to the eighth session done.
Category
Behavior

2

Description
In the control group of mothers in childbirth preparation classes according to their past.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Gonabad University of Medical Sciences
Full name of responsible person
Fateme yaghoobi moghadam bilondi
Street address
Gonabad university of medical sciences،Gonabad
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud University of Medical Sciences," Tir" Square,Shahroud.
City
Shahroud
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; Shahroud 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
Shahroud university of medical sciences
Full name of responsible person
Fateme yaghoobi moghadam bilondi
Position
Master science of student counseling midwiferys
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, "Tir" Square,Shahroud.
City
Shahroud
Postal code
3614773955
Phone
+98 51 5733 2689
Fax
Email
f.yaghoobi.m@gmail.com;yaghoobi@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Afsaneh keramat
Position
Dr pregnancy health
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences," Tir" Square,Shahroud.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
Email
keramat1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Fateme yaghoobi moghadam bilondi
Position
Master science of student counseling midwiferys
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences,
City
Shahroud
Postal code
3614773955
Phone
+98 51 5733 2689
Fax
Email
f.yaghoobi.m@gmail.com;yaghoobi@shmu.ac.ir
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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