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Investigating the effects of optimism training with Training the benefits of natural childbirth on attitude and intentions to choose the mode of delivery

Protocol summary

Summary
The purpose of study: to investigating the effects of optimism training with Training the benefits of natural childbirth on attitude and intentions to choose the mode of delivery. Method: Randomized clinical trial The study population: pregnant women referring to the health centers with Inclusion criteria: First pregnancy and single fetus, Gestational age was 30-34 weeks, - Age between18-35 years old, No history of infertility, Without indication of cesarean section and Exclusion criteria is Mother does not have a medical condition, AF fluid and position of placenta according to ultrasound was normal Sample size: 96 Intervention study: Optimism training with Training the benefits of natural childbirth derived from Seligman's theory of learned optimism, during 6 session of the 60-minute and training the benefits of natural childbirth group, during 4 session of the 60-minute, have been studied.. Pre-test and post-test was performed with using valid and reliable questionnaire. Data were analyzed with ANOVA test, chi-square, Fisher, Wilcoxon, t-test and using the software SPSS (version 22). Time of the study: November 2014 until February 2015 The main outcome variable: attitude to the mode of delivery.intentions to choose the mode of delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015063022995N1
Registration date: 2015-09-19, 1394/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-19, 1394/06/28
Registrant information
Name
Mahin Esmaeili Darmian
Name of organization / entity
Faculty of nursing-midwifery of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3621 1299
Email address
esmaeilim911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mshhad University of Medical Sciences
Expected recruitment start date
2014-11-17, 1393/08/26
Expected recruitment end date
2015-02-15, 1393/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of optimism training with Training the benefits of natural childbirth on attitude and intentions to choose the mode of delivery
Public title
the effects of optimism training and Training the benefits of natural childbirth during pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- Iranian nationality and living in Mashhad city; 2- At least primary education; 3- Singleton pregnancy and live fetus with cephalic presentation; 4- Without indication of cesarean section; 5- Gestational age According to first trimester ultrasound and last menstrual period was 30-34 weeks; 6- First pregnancy; 7- AF fluid and position of placenta according to second trimester ultrasound was normal; 8- Age between18-35 years old; 9- No history of infertility; 10- BMI was in range 19/8-29; 11- Own and his wife are employees of medical staff; 12- In the first trimester of ultrasound fetal abnormality is not detected; 13- Mother does not have a medical condition; 14- During the last 6 months have been intense spiritual emotions; 15-During the pregnancy is not continuing education about the advantages and disadvantages of delivery; 16- Having phone number to call; 17- Average score optimism in the two intervention groups, between 19-10. Exclusion criteria: 1- Dose not participate in two or more sessions; 2- Leaving the class up to 15 minutes before the training; 3- Unwilling to continue to participate in research; 4- In tests to measure optimism, attitude and choice of mode of delivery, before and after the intervention dose not participate; 5- Fetal death occurred during the study; 6- Intense emotions experienced since the start of the study until delivery; 7- Delivery between 39-35 weeks of pregnancy occurred; 8- During the pregnancy trained continuing education about the advantages and disadvantages of delivery; 9- Mother have a medical problem; 10- Signs of fetal distress exist.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
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
Faculty of Nursing & Midwifery of mashhad
Street address
ibn cina street, , Doctorate Crossroads, University street, mashhad
City
mashhad
Postal code
9137913199
Approval date
2014-06-12, 1393/03/22
Ethics committee reference number
930321

Health conditions studied

1

Description of health condition studied
pregnancy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Attitudes to the type of delivery
Timepoint
Immediately after the intervention
Method of measurement
Questionnaires to measure attitudes toward of natural birth and Caesarean section

2

Description
Intentions to choose the mode of delivery
Timepoint
Immediately after the intervention
Method of measurement
Checklist of reviewing decision making about type of delivery

Secondary outcomes

empty

Intervention groups

1

Description
Optimism training with Training the benefits of natural childbirth derived from Seligman's theory of learned optimism, during 6 session of the 60-minute With the participation of samples group with lectures, discussions were conducted in the form of examples and exercises active, has been studied. First session: Introduction Members, Understanding the types of delivery (normal and caesarean section) advantages and disadvantages of each. Second session: The discussion about the concept of optimism and pessimism and its impact on the lives and features of optimistic and pessimistic. Third session: The relationship between thoughts, feelings, and disasters(ABC). Fourth Session: Introduction to of negative automatic thoughts and irrational beliefs. Fifth Session: Modify documents. Sixth session: Training to cope with negative thoughts and pessimistic
Category
Other

2

Description
Training the benefits of natural childbirth group, during 4 session of the 60-minute, have been studied. First session: Generalities of the stages of birth, type of delivery (normal, cesarean section, the instrument) Along with film showings image. Session II: description of the advantages and disadvantages of maternal and neonatal Caesarean section delivery along with film and photo. Third session: description of the advantages and disadvantages of maternal and neonatal natural childbirth along with film and photo. Forth session: Active training by drawing two columns as the advantages and disadvantages of natural childbirth and caesarean section and giving the flash card samples for the detection of the relevant column. Understanding how to do vaginal examination and repair of episiotomy and a description Along with film showings image
Category
Other

3

Description
The control group was not action
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid motahari Health Center
Full name of responsible person
Street address
City
mashhad

2

Recruitment center
Name of recruitment center
silo Health Center
Full name of responsible person
Street address
City
mashhad

3

Recruitment center
Name of recruitment center
ghods Health Center
Full name of responsible person
Street address
City
mashhad

4

Recruitment center
Name of recruitment center
golshahr Health Center
Full name of responsible person
Street address
City
mashhad

5

Recruitment center
Name of recruitment center
Fourteen masoom Health Center
Full name of responsible person
Street address
City
mashhad

6

Recruitment center
Name of recruitment center
Bahr Abad Health Center
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Research and Technology of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, side of Hoveyze cinema, University street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Research and Technology of Mashhad 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
Mashhad Faculty of Midwifery & Nursing
Full name of responsible person
Mahin Esmaeili Darmian
Position
Master student of Midwifery
Other areas of specialty/work
Street address
Ibn Sina street, Doctora Crossroads, Daneshgah St., Mashhad
City
Mashhad
Postal code
Phone
+98 51 3621 1299
Fax
Email
nms.it@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Faculty of Midwifery & Nursing
Full name of responsible person
Sedigheh Yousef Zadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ibn Sina street, Doctora Crossroads, Daneshgah St., Mashhad
City
Mashhad
Postal code
Phone
+98 51 3621 1299
Fax
Email
nms.it@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad Faculty of Midwifery & Nursing
Full name of responsible person
Mahin Esmaeili Darmian
Position
Master student of Midwifery
Other areas of specialty/work
Street address
Ibn Sina street, Doctora Crossroads, Daneshgah St., Mashhad
City
Mashhad
Postal code
Phone
+98 51 3621 1299
Fax
Email
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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