Protocol summary

Study aim
Determining The effect of cognitive group counseling on the motivation of a childbearing in women without children
Design
Clinical trial, control group, non-blind, randomized
Settings and conduct
The population of the present study consisted of unprovoked women who have filed in the Qom district of the Qom health centers and who have been over 2 years of their common life and who have not taken a pregnancy, and will continue to use prophylaxis methods. Sixty-six subjects were randomly divided into two groups of control and intervention . Six sessions of 60 minutes were held for the intervention group. The intervention group divided into 16 and 15 groups and divided into the two counseling groups. The method of holding sessions for the intervention group is 1 session per week and 6 consecutive weeks. To collect information, a standard questionnaire will be used.
Participants/Inclusion and exclusion criteria
Entry requirements:Iranian and resident of Qom; written consent for participation in research; literacy; reading and writing; physical and mental disability; or clear mental disorders that impede learning. More than 2 years have passed since their marriage and they have not taken any measures for pregnancy, they now use contraceptive methods, those who in the positive dimension score below the average and in the negative dimension gain a higher score than the average , Does not have a chronic or psychological disorder affecting fertility.Exit Conditions:Women who do not want to continue their studies have not fully participated in counseling sessions.
Intervention groups
A total of 6 60-minute sessions will be held for the intervention group. How to hold sessions for the intervention group 1 session per week and 6 consecutive weeks. The control group does not attend any session.
Main outcome variables
Motility to childbearing before and after intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180415039310N1
Registration date: 2018-05-31, 1397/03/10
Registration timing: registered_while_recruiting

Last update: 2018-05-31, 1397/03/10
Update count: 0
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Narges Sheikhghanbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3289 0603
Email address
n.sheikhghanbari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-15, 1397/01/26
Expected recruitment end date
2018-07-17, 1397/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive group counseling on the motivation of a childbearing in women without children
Public title
The effect of group counseling on the motivation of a childbearing in women without children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian and resident of Qom Written consent for participation in the research Have literacy to read and write Physical and mental disabilities or clear mental disorders that impede learning. More than 2 years have passed since their marriage Do not take any steps to get pregnant Currently, they use contraceptive methods Those who score in the positive dimension below the average and in the negative dimension get higher scores than the average Do not have chronic or psychological illness affecting fertility
Exclusion criteria:
Women who do not want to continue their studies In the counseling sessions he has not fully participated (absence more than 60 minutes in total meetings)
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
They are randomly assigned to two groups of intervention and control. The randomization method is A and B, which are placed in four blocks A and B.
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
Arak University of Medical Sciences
Street address
Dr. Mohammad Rafiee,Research Deputy, Supreme Prophet complex,Basij Square,Sardasht,Arak
City
Arak
Province
Ghoum
Postal code
3848176941
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.ARAKMU.REC.1396.285

Health conditions studied

1

Description of health condition studied
Childbearing Motivations
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
primary child bearing motivation
Timepoint
Before intervention - after intervention
Method of measurement
Childbearing Motivations Scale

Secondary outcomes

1

Description
Secondary child bearing motivation
Timepoint
Before intervention - after intervention
Method of measurement
Childbearing Motivations Scale

Intervention groups

1

Description
Intervention group: In this study, an attempt was made to determine the effect of cognitive group counseling on the parenting motive in unmarried women meeting sessions. A total of 6 60-minute sessions will be held for the intervention group. How to hold sessions for the intervention group 1 session per week and 6 consecutive weeks.
Category
Behavior

2

Description
Control group: no action
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Qom Health Centers
Full name of responsible person
Narges sheikh ghanbari
Street address
Qom University of Medical Sciences, ShahidBeheshti،Qom Health Center
City
Qom
Province
Ghoum
Postal code
3716889788
Phone
+98 25 3660 0017
Email
n.sheikhghanbari@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
دکتر محمد ارجمند زادگان
Street address
Research Deputy,Supreme Prophet ,Basij Square,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
نرگس شیخ قنبری
Position
Student Masters Counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.18,Salman town,Daniel Avenue
City
Qom
Province
Ghoum
Postal code
3716889788
Phone
+98 25 3289 0603
Email
n.sheikhghanbari@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayon Vakilian
Position
Ph.D. in Reproductive Health and Academic Member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery,University of Medical Sciences,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
dr.kvakilian@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Narges sheikhghanbari
Position
دانشجوی کارشناسی ارشد مشاوره در مامایی
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.18,Salman town,Daniel Avenue
City
Qom
Province
Ghoum
Postal code
3716889788
Phone
+98 25 3289 0603
Email
n.sheikhghanbari@arakmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Publish document as article
When the data will become available and for how long
After a year of thesis defense
To whom data/document is available
All people
Under which criteria data/document could be used
Notices
From where data/document is obtainable
Magazines
What processes are involved for a request to access data/document
Onlin
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