determine the effect of group education on the anxiety of pregnant women at risk of preterm delivery
Design
This study is a clinical trial with two groups of intervention and control. 72 pregnant women at risk of preterm delivery with gestational age of 24-28 weeks entered the study at Shaheed Akbar Abadi Hospital in Tehran. block randomization method with blocks of 4, they will be divided in to two groups: control and intervention.
Settings and conduct
Participants ,who have conditions for entry the study, will be divided randomly into two groups.The intervention group (36 persons), In addition to routine pregnancy care, six 60-minute sessions of Group education Will receive during 6 weeks (once a week). The control group (36 persons) only received routine pregnancy care. The Pregnancy Related Anxiety Questionnaire Vanden Berg is completed three times before, the end of the 6th session and one month after the end of the session in the intervention group and before, the 6th and 10th week after the study in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Iranian; Resident in Tehran; With lowest literacy of reading and writing; Willingness to participate in the research; Single and live fetus; Gestational age between 24 and 28 weeks; Scores 10 or more of 10 from Holbrook risk-scoring for preterm labour questionnaire; Having anxiety score (17-119) on the Vanden Berg anxiety scale.
Exclusion criteria:
Having drug addiction; History of mental illness
Intervention groups
Intervention groups: receive routine care during pregnancy and 6 sessions of Group education.
Control groups: receive routine care during pregnancy
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041965N1
Registration date:2019-02-06, 1397/11/17
Registration timing:registered_while_recruiting
Last update:2019-02-06, 1397/11/17
Update count:0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
Somayeh Bazrafshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4417 1527
Email address
bazrafshan.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group education on the anxiety of pregnant women at risk of preterm delivery
Public title
The effect of group education on the anxiety of pregnant women at risk of preterm delivery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian
Resident in Tehran
With lowest literacy of reading and writing
Willingness to participate in the research
Single and live fetus
Gestational age between 24 and 28 weeks
Scores 10 or more of 10 from Holbrook risk-scoring for preterm labour questionnaire
Having anxiety score (17-119) on the Vanden Berg anxiety scale
Exclusion criteria:
Having drug addiction
History of mental illness
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment by blocking method and using all possible combinations of AABB blocks.For each combination, a code will be allocated and 18 codes will be randomly selected.Then, with regard to the blocks corresponding to each code and the existing combinations, we will add people to the study.
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
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.522
Health conditions studied
1
Description of health condition studied
Preterm labour
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery
Primary outcomes
1
Description
anxiety
Timepoint
before, the end of the 6th session and one month after the end of the session in the intervention group and before the 6th and 10th week after the study in the control group
Method of measurement
Pregnancy Related Anxiety Questionnaire Vanden Berg
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In this study, McNamara anxiety management is used in six one-hour sessions during six weeks, when pregnant mothers at risk of preterm delivery receive educational intervention in groups of 4 to 6 mothers. In each session, new topics are presented after reviewing previous ones, and issues discussed are summed up at the end of the session.The sessions are as follows: Session1:welcome, an overview of the rules and regulations of group educating sessions, meet the members together, research objectives, preterm delivery.Session 2: presenting definitions of anxiety, Introducing general effects of anxiety on various body systems, and examining physical and behavioral effects of anxiety, Introduction to the importance of learning anxiety management skills. Session 3: Subjective and rational strategies for dealing with anxiety. Session 4: physical ways of coping with anxiety. Session 5: communication skills training. Session 6: building self-confidence and self-esteem, review previous sessions.anxiety levels is measured using pretest and post test, and anxiety levels in two groups are compared through post test and follow-up test.
Category
N/A
2
Description
Control group receives during pregnancy routine care included pregnancy examination, fetal heart rate and all of recommended program in ministry of health and medical education guideline (after the end of educational sessions in intervention group to observe ethics research booklet, containing advice, will be provided to the control group).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Akbar Abadi hospital
Full name of responsible person
Somayeh Bazrafshan
Street address
Molavi Street
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
bazrafshansomayeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Somayeh Bazrafshan
Position
Senior Student of Consultation in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rashidyasemi Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
bazrafshan.somayeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh Bazrafshan
Position
Senior Student of Consultation in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rashidyasemi Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1000
Email
bazrafshan.somayeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh Bazrafshan
Position
Senior Student of Consultation in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rashidyasemi Street
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
bazrafshan.somayeh@gmail.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
Not applicable
Title and more details about the data/document
The data after ending the thesis is worthy of publishing
When the data will become available and for how long
ُُSix month after ending the thesis
To whom data/document is available
Researchers, IRAN University of Medical Sciences, University and Hospital Researchers
Under which criteria data/document could be used
Data after analysis, is available to others through publication in scientific journals
What processes are involved for a request to access data/document
Usually, information will be available through the publication of the paper. But if the person asks for more and more information, can submit
application by email .