Determining the effect of positive psychological counseling on anxiety in pregnant women over 35 years
Design
A randomized controlled clinical trial with parallel groups will be performed on 46 patients
Settings and conduct
The study population will be selected from pregnant mothers over 35 years of age referring to comprehensive health centers in Zanjan. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: be literate; gestational age 24-35 weeks; no history of known psychiatric disorders being treated in the mother based on personal statements and evidence in the file; willingness to participate in the study; no history of drug and psychotropic use; age over 35 years old; no stressful events in the last 6 months (accidents, death of a loved one, separation from a spouse, bankruptcy, severe disputes, immigration); no history of high-risk delivery; not having a child with congenital problems or cerebral palsy.
Exclusion criteria: do not attend more than one training session; leave the training class before completing it; occurrence of stressful events in the research process (accidents, death of a loved one, separation from a spouse, bankruptcy, severe disputes, immigration); high-risk pregnancies such as multiple births and diabetes, HTN and IUGR; informing the mother of fetal anomalies; abortion.
Intervention groups
In the 24th to 35th weeks of pregnancy, positive psychology interventions will be held in eight virtual 70-90 minute sessions individually two days a week, and the control group will receive routine pregnancy care training.
Main outcome variables
Pregnancy anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160521027994N7
Registration date:2021-07-18, 1400/04/27
Registration timing:prospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
Taraneh Emamgholi khooshehchin
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8318
Email address
khoosheh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of counseling with positivity approach and routine care on anxiety in pregnant women over 35 years
Public title
The effect of counseling on pregnancy anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 24 to 35 weeks
Be literate
Willingness to participate in the study
Age over 35 years
Internet access and Android phone
Exclusion criteria:
Existence of a history of known psychiatric disorders in the mother based on individual statements and evidence in the file
History of drug and psychotropic use
Child with congenital problems or cerebral palsy
Child with congenital problems or cerebral palsy
Age
From 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, first, the easy sampling method will be used and then individuals with inclusion criteria will be divided into two groups of intervention and control using random block division. In this way, first, using 4 blocks, the arrangement of people next to each other in each block will be determined, and then a number will be assigned to each block, and 12 blocks will be determined to provide the required number of samples. Then, using the table of random numbers, the sequence of using the blocks will be determined. Entry to each group in each block will be done by the number of selected blocks and the arrangement inside the block, respectively. The number of people in each group will be 23.
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4513665758
Approval date
2021-06-16, 1400/03/26
Ethics committee reference number
IR.ZUMS.REC.1400.110
Health conditions studied
1
Description of health condition studied
Pregnancy anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Pregnancy anxiety
Timepoint
Before the intervention, the last consultation session and two months after the intervention
Method of measurement
Pregnancy Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in addition to the positive psychology approach for the intervention group will be held in 8 sessions of 70-90 minutes twice a week and at the end of each session homework will be given to participants.
Category
Other
2
Description
Control group: For the control group, routine pregnancy care will be performed. Finally, after the intervention, if desired, the members of the control group will be provided with a description of counseling sessions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health department
Full name of responsible person
Hadis Jalilvand
Street address
Azadi Square, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 21 3338 3629
Email
hadis.j120@ 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
Azadi Square, Zanjan University of Medical Sciences
City
Zanja
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3342 0677
Email
shoghli@zums.ac.ir
Grant name
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
Hadis Jalilvand
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3338 3629
Email
hadis.j120@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Taraneh Emamgholi khooshehchin
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
khoosheh@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hadis Jalilvand
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3338 3629
Email
hadis.j120@gmai.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
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
The release schedule is not yet known.
When the data will become available and for how long
The release schedule is not yet known.
To whom data/document is available
The release schedule is not yet known.
Under which criteria data/document could be used
The release schedule is not yet known.
From where data/document is obtainable
The release schedule is not yet known.
What processes are involved for a request to access data/document