Health Centers of Zahedan City, Semi-experimental, Available sampling, Simple randomized
Participants/Inclusion and exclusion criteria
Inclusion criteria: women who aged from 18 to 35 years and have gestational age from 26 to 32 weeks considered for the study.
Exclusion criteria: Mothers who have medical and surgical complications, more than singleton birth, unwanted pregnancy, addiction, mental illness, acute physical illness or chronic underlying diseases, stressful incidence in recent 6 months, participation in physiological delivery workshops were excluded from the study.
Intervention groups
Muscle Relaxation,Guided Imaginary
Main outcome variables
Reducing the Fear of childbirth, Happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038133N1
Registration date:2018-04-30, 1397/02/10
Registration timing:retrospective
Last update:2018-04-30, 1397/02/10
Update count:0
Registration date
2018-04-30, 1397/02/10
Registrant information
Name
Tahereh Boryri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
boreyri@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2017-11-21, 1396/08/30
Trial completion date
empty
Scientific title
Comparison muscle relaxation and guided imagery on happiness and fear of childbirth in primiparous women referred to health centers in Zahedan in 2017
Public title
Compare of muscle relaxation and guided imagery on happiness level and Fear of childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Full term,Singleton pregnancy,Wanted pregnancy,No Addiction
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Actual sample size reached:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Sibe system
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Hesabi Sqr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-08-02, 1396/05/11
Ethics committee reference number
8322
Health conditions studied
1
Description of health condition studied
Labor pain reduction
ICD-10 code
O80.9
ICD-10 code description
Single spontaneous delivery, unspecified
Primary outcomes
1
Description
Muscle Relaxation,Guide Imagery
Timepoint
4Weeks
Method of measurement
Briselin & Oxford Questionnaire
2
Description
Reduce Fear , Increase Happiness
Timepoint
4 Weeks
Method of measurement
Briselin & Oxford Questionnaire
Secondary outcomes
1
Description
Decreasing fear and Increasing happiness
Timepoint
4 Weeks
Method of measurement
Briselin and Oxford questionnaires
Intervention groups
1
Description
Intervention group: Muscle relaxation
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Health Centers
Full name of responsible person
Boryri, Tahereh
Street address
Mashahir Sqr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816834789
Phone
+98 54 3344 2481
Email
boryri_tahereh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Pardis Hessabi Squre
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Tahereh ,Boryri
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashahir Sqr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3343 0948
Email
boryri_tahereh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Tahereh Boryri
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashahir Squre
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 33442482
Email
boryri_tahereh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Boryri, Tahereh
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Mashahir Squre
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3343 0948
Email
boryri_tahereh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The Information is secret and secure and entering person are with code
When the data will become available and for how long
Six months after printing results
To whom data/document is available
Academic Institutions
Under which criteria data/document could be used
To provide better services and facilities to pregnant mothers and reducing cesarean section
From where data/document is obtainable
Pregnant women with contact number and home address
What processes are involved for a request to access data/document