Protocol summary

Study aim
General Purpose: determining the effect of yoga on anxiety and self-efficacy in labour of primipar women referred to health centers in Zahedan in 2017 Special Purpose: Determination and Comparison of mean changes in anxiety score of primipar women in two groups of intervention (yoga) and control Determination and comparison of mean changes in self-efficacy score in labour of primipara women in two groups of intervention (yoga) and control
Design
Studied population included primipar women referred to health centers. sampling and randomization method is as follows, first the list of all eligible women is prepared from the selected health centers, then after receiving permission of participated eligible women, individuals with randomization block will be divided into two groups: intervention and control. Each participant in the intervention and control group is assigned a code. Both of intervention and control group included 30 individuals
Settings and conduct
. Intervention is conducted in the hall where Yoga instructor by a trained researcher are present. This is a clinical trial study. Since the nature of the study is sport, it is not possible to blind people. Only the statistics specialist will be unaware of this matter that, which person belongs to which group (intervention or control).
Participants/Inclusion and exclusion criteria
The criteria for entering the study are: gestational age of 18-40 , singleton, gestational age of 27-26 weeks, Iranian, having reading and writing skills, non-use of psychosocial drugs, non-attendance at yoga classes and similar sports, lack of physical illness (performing yoga exercises can endanger the health of one's or his fetus) such as injury or spinal cord surgery, no recurrent abortions, lack of addiction, lack of physical and mental illness, lack of obstetric problems such as cerclage, high fever, rupture of membranes, Placentaprevia and polyhydramnios.Exclusion criteria: internal problems and Surgeryو hypertension in pregnancy و Diagnosing Placenta Previa , threat of premature labor - unwillingness to cooperate and participate in aerobics and Pilates classes , Lack of regular attendance in meetings.
Intervention groups
Intervention Two questionnaires namely, anxiety Inventory and self-efficacy with a demographic information form are completed at the same time on 26th week in intervention and control group. Yoga intervention is conducted from week 27 to 31 for 5 weeks every three days. The post-test is repeated at week 34 from both group.
Main outcome variables
Limitations Non-attendance at yoga classes that is followed up by phone. If there is a problem during the exercise, a visit of gynecologist will be taken.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160704028794N2
Registration date: 2018-01-01, 1396/10/11
Registration timing: registered_while_recruiting

Last update: 2018-01-01, 1396/10/11
Update count: 0
Registration date
2018-01-01, 1396/10/11
Registrant information
Name
farnoosh khojasteh
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33442481
Email address
khojasteh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-04-23, 1397/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga in pregnancy on anxiety and child birth self –efficacy of nulliparous pregnant women
Public title
The effect of yoga in pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous pregnant women Pregnancy single parenthood Pregnancy Age English 26-32 weeks Literacy reading and writing
Exclusion criteria:
Lack of physical and mental illness Absence of midwifery problems ( of Cerebral palsy) Repetitive abortion Cerclage Preterm rupture of membrane
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a clinical trial study Since the nature of the study is sport, it is not possible to blind people. Only the statistics specialist will be unaware of this matter that, which person belongs to which group (intervention or control).
Placebo
Not used
Assignment
Single
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
SquareHesabi; Daneshgah Ave
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.ZAUMS.REC.1396.152

Health conditions studied

1

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

Primary outcomes

1

Description
The score that a person receives from standardized pregnancy anxiety questionnaires.The score that a person earns from self-efficacy questionnaires.First, the pregnancy anxiety questionnaire and Childbirth Self Efficacy Inventory in the 27-26 weeks for both groups, then after five weeks of intervention, two weeks after the last intervention in both groups
Timepoint
First, the pregnancy anxiety questionnaire and childbirth self efficacy inventory in the 27-26 weeks for both groups, then after five weeks of intervention, two weeks after the last intervention in both groups
Method of measurement
Standardized pregnancy anxiety questionnaires childbirth self efficacy inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, individuals in 27th week of gestation for 5 weeks each week will receive a 45-60 minute session of yoga exercises,Including position-selecting, controlled respiratory exercises, and Releasing and relaxation exercises in the gym where yoga instructors and researcher are present.
Category
Lifestyle

2

Description
Control group: The control group will receive the usual care of the pregnancy.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan Health Center
Full name of responsible person
Farnoosh Khojasteh
Street address
Zahedan Hearmand Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
khojasteh@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor Mohammad Bakhshani
Street address
Dr Hasabi's Square, Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
taheri@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
Khojasteh. Farnoosh
Position
science committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Blvd Behdasht
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
khojasteh@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Khojasteh. Farnoosh
Position
science committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Behdasht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
khojasteh@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Khojateh. Farnoosh
Position
science committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,Behdaht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
khojasteh@zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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