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The effect of counselling on coping with decision to continue an unplanned pregnancy: a randomized controlled clinical trial

Protocol summary

Study aim
Determine the effect of counselling on coping with decision to continue an unplanned pregnancy
Design
The study is a randomized controlled clinical trial on 82 unplanned pregnant women referring to health centers of Tabriz. The participants will be randomly assigned in two groups of counselling and control with a 1: 1 ratio, using RAS software according to 4 and 6 blocks.
Settings and conduct
From 80 health centers of Tabriz,16 will be selected randomly. Then the participants will be selected through convenience sampling. After obtaining written consent form, pre-test questionnaires including socio-demographic questionnaire, NU-PCI, PRAQ-R2, and worries and perceived threats of unplanned pregnant women will be completed. 4-8 weeks after the intervention, post-test questionnaires (NU-PCI, PRAQ-R2, and worries and perceived threats of unplanned pregnant women) will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:15-49 years old married women, Unplanned pregnant women with decision to continue the pregnancy, Gaining 14 or higher scores in avoiding domain of the NU-PCI tool, Gaining 27 or higher scores in worries and perceived threats questionnaire. Exclusion criteria: known psychiatric disorders according to women statements, Illegal pregnancies, Fetal anomaly, High risk Pregnancies, Family problems
Intervention groups
For the intervention group, four counselling sessions, once a week for 60 to 90 minutes would be held. The Control group will receive only routine prenatal care.
Main outcome variables
The main outcome of the study is comparing the mean scores of coping strategies of unplanned pregnant women between the two groups, before and 4-8 weeks after intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170506033834N5
Registration date: 2018-05-03, 1397/02/13
Registration timing: registered_while_recruiting

Last update: 2018-05-03, 1397/02/13
Update count: 0
Registration date
2018-05-03, 1397/02/13
Registrant information
Name
Roghaiyeh Nourizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
nourizadehr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-24, 1397/01/04
Expected recruitment end date
2018-06-24, 1397/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counselling on coping with decision to continue an unplanned pregnancy: a randomized controlled clinical trial
Public title
The effect of counselling on coping with decision to continue an unplanned pregnancy: a randomized controlled clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
15-49 years old married women Women with unplanned pregnancy with the decision to continue pregnancy Getting 14 or higher scores in avoiding domain of the NU-PCI tool Getting 27 or higher scores in tool of perceived worries and threats
Exclusion criteria:
known psychological disorders according to women statements Illegal pregnancies Fetal abnormalities high risk Pregnancies family problems
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly allocation to intervention and control groups
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 Tabriz University of Medical Sciences
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR-TBZMED.REC.1396.793

Health conditions studied

1

Description of health condition studied
Prablems related to unwanted pregnancy
ICD-10 code
z64
ICD-10 code description
Problems related to certain psychosocial circumstances

Primary outcomes

1

Description
Women's coping with decision to continue an unplanned pregnancy
Timepoint
Before the intervention and 4-8 weeks after the intervention
Method of measurement
Revised Prenatal Coping Inventory: NU-PCI

Secondary outcomes

1

Description
Anxiety in women with unplanned pregnancy
Timepoint
Before the intervention and 4-8 weeks after the intervention
Method of measurement
Revised Pregnancy Related Anxiety Questionnaire: PRAQ-R2

2

Description
Worries and perceived threats
Timepoint
Before the intervention and 4-8 weeks after the intervention
Method of measurement
Unplanned pregnant women's worries and perceived threats Questionnaire

Intervention groups

1

Description
For intervention group, four consultation sessions, once a week, for 60 to 90 minutes would be held.
Category
Behavior

2

Description
The control group will receive only routine prenatal care.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sardrood health center
Full name of responsible person
Nayyer Bayrampour
Street address
Seyed Ahmad Street, Above Asra kindergarten
City
Tabriz
Province
East Azarbaijan
Postal code
5361765794
Phone
+98 41 3420 5472
Email
nayyer1984b@gmail.com

2

Recruitment center
Name of recruitment center
Eram health center
Full name of responsible person
Nayyer Bayrampour
Street address
Eram Town, District 8, Almahdi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5147977193
Phone
+98 41 3230 4948
Email
Nayyer1984b@gmail.com

3

Recruitment center
Name of recruitment center
Azadi health center
Full name of responsible person
Nayyer Bayrampour
Street address
Mofatteh, Telecommunication station
City
Tabriz
Province
East Azarbaijan
Postal code
5144813111
Phone
+98 41 3233 4199
Email
nayyer1984b@gmail.com

4

Recruitment center
Name of recruitment center
Emamieh health center
Full name of responsible person
Nayyer Bayrampour
Street address
Hakim Nezami Street, Meraj Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5164843918
Phone
+98 41 3541 9330
Email
nayyer1984b@gmail.com

5

Recruitment center
Name of recruitment center
Hokmabad health center
Full name of responsible person
Nayyer Bayrampour
Street address
Bahar Street, Infront of Asadabadi Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5185716133
Phone
+98 41 3280 1471
Email
nayyer1984b@gmail.com

6

Recruitment center
Name of recruitment center
Sadeginejad health center
Full name of responsible person
Nayyer Bayrampour
Street address
Hojjati Street (Professor Jafari), Teacher Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5186943111
Phone
+98 41 3288 2585
Email
nayyer1984b@gmail.com

7

Recruitment center
Name of recruitment center
Gomtapeh health center
Full name of responsible person
Nayyer Bayrampour
Street address
Yekah Dokkan, Shahid Gharabaghi Street
City
Tbriz
Province
East Azarbaijan
Postal code
5146967155
Phone
+98 41 3235 7615
Email
nayyer1984b@gmail.com

8

Recruitment center
Name of recruitment center
Jamshid Abad health center
Full name of responsible person
Nayyer Bayrampour
Street address
Monajjem Street
City
Tabriz
Province
East Azarbaijan
Postal code
5185757385
Phone
+98 41 3280 8035
Email
nayyer1984b@gmail.com

9

Recruitment center
Name of recruitment center
Sayad Shirazy health center
Full name of responsible person
Nayyer Bayrampour
Street address
Pasdaran Street ، Infront of Malakouti Shops
City
Tabriz
Province
East Azarbaijan
Postal code
5147743813
Phone
+98 41 3235 2121
Email
nayyer1984b@gmail.com

10

Recruitment center
Name of recruitment center
Ebnesina health center
Full name of responsible person
Nayyer Bayrampour
Street address
Taleghani Town، 18 meters Idem
City
Tabriz
Province
East Azarbaijan
Postal code
5175854431
Email
nayyer1984b@gmail.com

11

Recruitment center
Name of recruitment center
Mojahedin health center
Full name of responsible person
Nayyer Bayrampour
Street address
Mofatteh Street, Shahid Imamdoost Avenue.
City
Tabriz
Province
East Azarbaijan
Postal code
5145797613
Email
nayyer1984b@gmail.com

12

Recruitment center
Name of recruitment center
Montazeri health center
Full name of responsible person
Nayyer Bayrampour
Street address
Maralan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165854568
Email
nayyer1984b@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Golgasht Ave, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Phone
+98 41 3479 6770
Email
nayyer1984b@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Nayyer Bayrampour
Position
MSc Student of Counseling in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
خیابان آزادی، خیابان شریعتی جنوبی
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
nayyer1984b@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Esmat Mehrabie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nayyer Bayrampour
Position
MSc Student of Counseling in Midwifery
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Azadi Street, South Shariati Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
nayyer1984b@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I have no plans for publication yet
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
RCT report as scientific paper
When the data will become available and for how long
15 months
To whom data/document is available
Editor in chief and reviewers of the journals, Authors of systematic review and meta-analysis
Under which criteria data/document could be used
For ensuring the data originality and evidence based decision- making
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Formal request
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