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The Effects of companionship of trained husbands beside their women during childbirth on women’s anxiety level, Isfahan University of Medical sciences, Zahraye Marzieh hospital, 2014

Protocol summary

Summary
Aim: Determining the effect of presence of husbands beside their women during childbirth on mother's anxiety level. Design: Randomized, three period, not blinded, three groups Population: Pregnant women visited in obstetric clinic and willing to deliver in labour part of Zahraye Marzieh hospital Inclusion criteria: Iranian women, Age between 20-35, First and wanted pregnancy, Gestational age of 28-37 weeks, not having an active or chronic history of psychological disorders, having the physical and psychological health to participate in educational classes for both women and their husbands, single fetus and presentation of head, not having congenital disorders according to sonography, no history of smoking, opium addiction, and alcohol drinking, vaginal and non-complicated delivery with healthy infant. Main exclusion criteria: Congenital disorders of fetus, Indication of cesarean section for any reason (umbilical cord prolapse, placenta previa, Decolman of placenta, ... ) , Encounter with any stressor like death of family members, special diseases or preterm labour (before 37W), Unwilling to continue of research, not participating in educational classes or presence in at least active phase of delivery, showing anxiety reactions from woman or her husband Sample size: 84 pregnant women Intervention: The effect of presence of husbands beside their women during childbirth. Time of intervention: Before, during, and after delivery Outcomes: Change of anxiety level

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120525376N1
Registration date: 2016-01-25, 1394/11/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Atefeh Salehi
Name of organization / entity
Faculty of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 3442 6105
Email address
atisaleh63@gmail.com
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Isfahan university of medical sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of companionship of trained husbands beside their women during childbirth on women’s anxiety level, Isfahan University of Medical sciences, Zahraye Marzieh hospital, 2014
Public title
The effect of presence of husband beside women during delivery on mother's anxiety level
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian women; Age between 20-35; First and wanted pregnancy; Gestational age of 28-37 weeks; not having an active or chronic history of psychological disorders; having the physical and psychological health to participate in educational classes for both women and their husbands; single fetus and presentation of head; not having congenital disorders according to sonography; no history of smoking; opium addiction and alcohol drinking; vaginal and non-complicated delivery with healthy infant. Exclusion criteria: Congenital disorders of fetus; Indication of cesarean section for any reason (umbilical cord prolapse, placenta previa, Decolman of placenta, ... ); Encounter with any stressor like death of family members; special diseases or preterm labour (before 37W); Unwilling to continue of research; not participating in educational classes or presence in at least active phase of delivery; showing anxiety reactions from woman or her husband.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 84
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
Moral committee of Isfahan university of medical sciences
Street address
update Isfahan university of medical sciences, Azadi squre, Hezar Jarib street, Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2014-05-08, 1393/02/18
Ethics committee reference number
Ir.mui.rec.1393.3.831

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
anxiety level
Timepoint
Before, during, and after delivery
Method of measurement
state-trait anxiety inventory

Secondary outcomes

1

Description
nothing
Timepoint
nothing
Method of measurement
nothing

Intervention groups

1

Description
Intervention group (With husband presence): In this group pregnant women with gestational age of 28-37 weeks in two times before delivery participated in pregnancy educational classes. In this classes they learned about process of hospitalization and role of husband during delivery and the way of emotional support of their wife during delivery. In the active phase of labor husbands with presence beside their wife supported them and encouraged them to collaborate with treatment team.
Category
Prevention

2

Description
Group 2 (With Doula support): In this group one of the relatives of pregnant woman who hadn't participated in educational classes before delivery, supported her emotionally during delivery.
Category
Prevention

3

Description
Group control (Without companion): In this group none of the relatives of pregnant women presented beside them during labor. Only routine cares by midwives was done for them during labor.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Zahraye Marzieh hospital
Full name of responsible person
Atefeh Salehi
Street address
Ghods square, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research, Isfahan university of medical sciences
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Isfahan university of medical sciences, Hezar Jarib street, Azadi square, Isfahan, Iran
City
Isfahan
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, Isfahan 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
Isfahan university of medical sciences, Faculty of nursing and midwifery
Full name of responsible person
Atefeh Salehi
Position
MS student of midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Isfahan university of medical sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 317922901
Fax
Email
atisaleh63@gmail.com; atisaleh63@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan university of medical sciences, Faculty of nursing and midwifery
Full name of responsible person
Atefeh Salehi
Position
MS student of midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Isfahan university of medical sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2901
Fax
Email
atisaleh63@gmail.com; atisaleh63@yahii.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan university of medical sciences, Faculty of nursing and midwifery
Full name of responsible person
Atefeh Salehi
Position
MS student of midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Isfahan university of medical sciences, Hezar Jarib street, Azadi square, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+98 31 3792 2901
Fax
Email
atisaleh63@gmail.com; atisaleh63@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
empty
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