1-Objectivs: this study aims to determine the effect of the presence of spouse in preparation class of delivery on fear of parturition and choosing type of childbirth in the women nulliparous 2- Design: This is a controlled randomized trial will be conducted in 152 pregnant women referred to delivery preparation class in Qazvin 3- How to do: eligible subjects will be selected by a convenience sampling method, Harman fear of delivery questionnaire will be completed for them and women with fear will enter the research. Then they division in two intervention group and control group by the 4block method. 4- Participants including major eligibility criteria: 20-30 Weeks pregnant women with low danger pregnancy؛first pregnancy؛singleton pregnancy؛ scores 28 and more in the fear of accouchement questionnaire and men that would like to participate in research. women who suffering by chronic disease including high blood pressure, diabetes, cardiovascular disease and etc.؛ sterility history and pregnancy using assist reproduction method؛ mental disease history or using medicine. Men and women who would not like to participate in study for any reason will be removed.5-interventions: beside usual medical care the intervention group should participate in 6 session delivery preparation class ,fill the fear of delivery questionnaire before and after intervention.6- The main outcome variables: fear of delivery and choosing type of delivery with or without the presence of spouse will be assessed before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705011113N8
Registration date:2017-09-10, 1396/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-10, 1396/06/19
Registrant information
Name
Fatemeh Ranjkesh
Name of organization / entity
Qazvin University Of Medical Scienes, Nursing & Midwifery school
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 9501
Email address
franjkesh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of spouse participation in childbirth preparation classes on fear of childbirth and Select the type of delivery in Nulliparous women
Public title
The effects of spouse participation on fear of childbirth and select the type of delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Women inclusion criteria :20_30 weeks pregnant women with low danger pregnancy ؛ First pregnancy ؛ Singleton pregnancy ؛ Ability to read and write؛ Scores 28 and more in the fear of accouchement questionnaire ؛ Availability and follow up. Men inclusion criteria : men who would like to participate in research؛ Ability to read and write ؛ Availability and follow up. Women Exclusion criteria : Women who would not like to participate for any reason ؛women who suffering by chronic disease including high blood pressure, diabetes, cardiovascular disease and etc ؛sterility history and pregnancy using assist reproduction method ؛Mental disease history or using medicine. Men Exclusion criteria: men who would not like to participate for any reason
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Bahonar boulevar , Qazvin University of Medical Sciences
City
Qazvin
Postal code
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
IR.QUMS.REC.1395.303
Health conditions studied
1
Description of health condition studied
Nulliparous women
ICD-10 code
Z34.0
ICD-10 code description
Supervision of normal first pregnancy
Primary outcomes
1
Description
Fear of childbirth
Timepoint
Before and after intervention
Method of measurement
Questionnaire
2
Description
Select the type of delivery
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will participate in 6 session (90 minutes per each session) in accouchement preparation class and their fear of accouchement and choosing type of accouchement will be assessed before and after the intervention.
Category
Prevention
2
Description
For the control group, accouchement preparation class will be held without husband.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dehkhoda Hospitol
Full name of responsible person
Fatemeh Ranjkesh
Street address
City
Qazvin
2
Recruitment center
Name of recruitment center
Soroud afarinesh Counseling Center
Full name of responsible person
Fatemeh Ranjkesh
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Bahonar Boulevar , Qazvin University of Medical Sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Iinstructor , Msc in midwifery
Other areas of specialty/work
Street address
Bahonar Boulevar , Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3323 7268
Fax
Email
fatemehranjkesh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor , Msc in midwifery
Other areas of specialty/work
Street address
Bahonar Boulevar , Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3323 7268
Fax
Email
Fatemehranjkesh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor , Msc in midwifery
Other areas of specialty/work
Street address
Bahonar Boulevar , Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3323 7268
Fax
Email
Fatemehranjkesh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)