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The effect of cognitive behavioral counseling on mental health and quality of life nulliparous pregnant women

Protocol summary

Summary
This study is an interventional study. The statistical population includes all pregnant women under the age of 20 weeks who are referred to Kamyaran city health centers. After obtaining the necessary permissions, the researcher will refer eligible pregnant women to the appropriate health care centers of Kamyaran City using the available sampling. Then a simple randomization method will be used to implement random assignment. This is done by a research fellow 60 consecutive sheets per sheet and placed in a container. Choice of even numbers will be grouped into group A and odd numbers will be grouped into group B. The groups A and B are non-randomly assigned to the intervention group or the control will be.The intervention group (30 people), in addition to the routine care of clinics for pregnant women, 8 sessions (if necessary, will increase to 10 sessions) 90 to 70 minutes Cognitive-behavioral group counseling conducted weekly by the researcher in the hall of the health center of Kamyaran city.The control group (30 people) will also receive routine care. First, the goals of the research are explained to the participants and written informed consent will be obtained. Then, the demographic form, general health questionnaire (28 questions) and short form (sf-36) quality of life questionnaire will be completed by both groups. In the next step, the intervention team will conduct 8 sessions once a week, 90 to 70 minutes, a cognitive-behavioral group counseling session for the intervention group. One month after the last cognitive behavioral group counseling session, the questionnaires will be completed again by the individuals in both groups and the scores will be compared. In all stages of the distribution and collection of questionnaires will be done by someone else who is not in the research. After completing the research, the control group will also receive a consultation for ethical reasons. The statistical analyst does not know which groups are assigned.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030532900N1
Registration date: 2017-09-29, 1396/07/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-29, 1396/07/07
Registrant information
Name
Sousan Heydarpour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3823 2679
Email address
sheydarpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciencesو Vice chancellor for research
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2017-08-05, 1396/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavioral counseling on mental health and quality of life nulliparous pregnant women
Public title
The effect of cognitive behavioral counseling on mental health and quality of life nulliparous pregnant women referred to health centers in Kamyaran
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Primal pregnant women; Pregnancy under 20 weeks old; Being literate; fluent in Persian; Without history of infertility; aged over 18; uncomplicated pregnancy;intended pregnancy; being Iranian. Exclusion criteria: Abortion or preterm labor during the study; admission to the hospital during the study; incidence of fetal or maternal complications during the study; the occurrence of any mental illness requiring drug use during the intervention; not attending more than 2 sessions of counseling sessions (up to 25% No more sessions); an unexpected stress during counseling; a person's dissatisfaction with the continuation of the study; the presence of a known disease in the fetus; separation or divorce; Mental or physical disorder; the use of anxiolytic and antidepressant drugs; participation in class relaxation, yoga and others like them ; incident or loss of family members during the past three months.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Boulvar, Kermanshah
City
Kermanshah
Postal code
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
KUMS.REC.1395.718

Health conditions studied

1

Description of health condition studied
quality of life
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Mental Health
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mental Health
Timepoint
Before and one month after the intervention
Method of measurement
General Health Questionnaire (GHQ)

2

Description
quality of life
Timepoint
Before and one month after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire - short form (sf-36)

Secondary outcomes

empty

Intervention groups

1

Description
Eight sessions of cognitive-behavioral group counseling (if necessary, increase to 10 sessions) 70 to 90 minutes per week, conducted by the researcher.
Category
Other

2

Description
Root care is provided for health care centers for the control group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Kamyaram city
Full name of responsible person
Street address
City
Kamyaran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences,
Full name of responsible person
Dr. behrooz.hamzeh
Street address
Vice Chancellor for Research and Technology, Building No. 2, Shahid Beheshti Boulvar
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences,
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sousan Heydarpour
Position
phD in Reproductive Health
Other areas of specialty/work
Street address
Nursing-Midwifery Faculty
City
Kermanshah
Postal code
Phone
+98 83 3828 2101
Fax
Email
s.heydarpour1394@yahoo.com; sheydarpour@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sousan Heydarpour
Position
phD in reproductive health
Other areas of specialty/work
Street address
Nursing-Midwifery Faculty
City
Kermanshah
Postal code
Phone
+98 83 3828 2101
Fax
Email
s.heydarpour1394@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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