Determining the effect of Cognitive- Behavioral counseling on the anxiety and worry of pregnant women about screening tests for fetal chromosomal disorders
Design
In this study, 52 pregnant mothers will be included in the study and will be randomly divided into two groups of intervention and control. Demographic questionnaire and Cambridge anxiety and Pregnancy anxiety questionnaire will be provided to both groups with each anxiety and worry score and the average anxiety and worry scores will be calculated by statistical methods.
Settings and conduct
Counseling sessions will be conducted by telephone under the supervision of supervisors and counselors. Questionnaires will be completed before, immediately at the end of the last telephone counseling session and 20-22 weeks of pregnancy in both intervention and control groups.
Participants/Inclusion and exclusion criteria
Having intermediate results in screening in the first trimester of pregnancy; willingness to participate and cooperate in research; have a minimum literacy, gestational age less than 14 weeks; not having any physical illness, pregnant woman does not have known mental illnesses and not taking drugs that affect the psyche; no complications such as miscarriage, moles, bleeding. Conditions for exclusion in the study: unwillingness of participants to continue cooperating in the study; absence for more than two sessions; problems during pregnancy (abortion, moles).
Intervention groups
The members of the intervention group will be 26 people.The intervention is performed in four sessions of 90- 120 minutes in the form of telephone counseling in two sessions per week which will be presented by the researcher. The control group will also receive nutritional counseling during pregnancy within the framework of the intervention group counseling
Main outcome variables
Anxiety and Worry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160608028352N8
Registration date:2020-08-29, 1399/06/08
Registration timing:prospective
Last update:2020-08-29, 1399/06/08
Update count:0
Registration date
2020-08-29, 1399/06/08
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Cognitive Behavioral counseling on anxiety and worry of pregnant women around the screening of fetal chromosomal abnormality
Public title
The effects of Cognitive Behavioral counseling on anxiety and worry of pregnant women around the screening of fetal chromosomal abnormality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having intermediate results in screening in the first trimester of pregnancy
Willingness to participate and collaborate in research
Have a minimum literacy
Gestational age less than 14 weeks of pregnancy
Not having any physical illness
Pregnant woman does not have known mental illness and not taking drugs that affect the psyche.
No complications such as miscarriage, moles, bleeding, etc.
Exclusion criteria:
Reluctance to participating in research and absence for more than two sessions
Pregnant woman with known mental illnesses and the use of psychotropic drugs that are self-reported.
Problems during pregnancy (miscarriage, moles, etc.) that cause double anxiety.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Sample selection method among pregnant women will be easy and accessible and then the participants will assigned to two groups of intervention and control using blocked randomization method. Four-dimensional blocks will be created, and in each block, half of the participants will be in the intervention group and the other half will be in the control group, randomly. Selection of the blocks will continue to achieve the total sample size (26 in the intervention group and 26 in the control group). Thirteen blocks will be selected from the random numbers table and the grouping of the participants will conduct according to the conditions set in the previous step.
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 Zanjan University of Medical Sciences
Street address
Ethics committee of Zanjan University of Medical Sciences, First floor, North side Azadi square
City
Zanjan
Province
Zanjan
Postal code
4515613113
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.ZUMS.REC.1399.132
Health conditions studied
1
Description of health condition studied
Worry
ICD-10 code
R45.2
ICD-10 code description
Unhappiness
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Worry of pregnant women around the screening of fetal chromosomal abnormality
Timepoint
At baseline, immediately after the intervention and 20-22 week
Method of measurement
Cambridge Worry Questionnaire
2
Description
Anxiety of pregnant women around the screening of fetal chromosomal abnormality
Timepoint
At baseline, immediately after the intervention and 20-22 week
Method of measurement
Pregnancy Related Anxiety Questionnaire (Van den Berg)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The members of the intervention group will be 26 people who will participate in the telephone counseling individually. Cognitive-Behavioral telephone counseling with members of the intervention group will be performed by the researcher, which will be in 4 sessions, two sessions of 90-120 minutes per week based on the prescribed protocol.
Category
Other
2
Description
The control group will consist of 26 people who, in addition to routine pregnancy care, will receive nutritional content with a consultation framework in the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban / rural health service centers of Khorramdareh city
Full name of responsible person
Esmat Vaezi
Street address
Shahid Rajaei St. Health Network
City
Khoramdareh
Province
Zanjan
Postal code
4571687149
Phone
+98 24 3552 4005
Email
vaezi.esmat@gmail.com
2
Recruitment center
Name of recruitment center
Comprehensive urban / rural health service centers of Abhar city
Full name of responsible person
Esmat Vaezi
Street address
South Taleghani, Tahmasebi Street Health Network
City
Abhar
Province
Zanjan
Postal code
4561789391
Phone
+98 24 3522 4006
Fax
+98 24 3524 4726
Email
vaezi.esmat@gmail.com
3
Recruitment center
Name of recruitment center
Comprehensive urban / rural health service centers of Soltanieh city
Full name of responsible person
Esmat Vaezi
Street address
Kosar Town Health Network
City
Soltanieh
Province
Zanjan
Postal code
4551753114
Phone
+98 24 3582 4512
Fax
+98 24 3582 4516
Email
vaezi.esmat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan University of Medical Sciences, First floor, North side Azadi
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Fax
Email
shoghli@zums.ac.ir
Grant name
Thesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Esmat Vaezi
Position
Msc student of midwifery counselling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan School of Nursing and Midwifery, Mahdavi Blvd, Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515786339
Phone
+98 24 3315 6344
Email
vaezi.esmat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
ِDr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zanjan School of Nursing and Midwifery, Mahdavi Blvd, Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515786339
Phone
+98 24 3315 6344
Fax
+98 24 3314 8319
Email
r.kharaghani@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zanjan School of Nursing and Midwifery, Mahdavi Blvd, Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515786339
Phone
+98 24 3315 6344
Fax
Email
r.kharaghani@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
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
A Portion of the data associated with the original outcome is shared
When the data will become available and for how long
Starting the access period from 1400
To whom data/document is available
Information will be available for scholars working in academic and academic institutions
Under which criteria data/document could be used
Apply this type of advice to another target group
From where data/document is obtainable
By e-mail address
What processes are involved for a request to access data/document
It will be answered by email and immediately after ensuring the plan is used.