Protocol summary

Study aim
Investigation of the effect of Solution-Focused group counseling on anxiety in pregnant women
Design
Controlled randomized counseling intervention, with pre-test-post-test design and with control and intervention group, single blind , block randomization method (20 to 4 blocks), in each block two allocations for the control group and two allocations for the group Intervention. Random sequence generation using site (https://www.sealedenvelope.com) Sequence concealment was used centrally 40 people in the intervention group and 40 people in the control group
Settings and conduct
After obtaining permission from the ethics committee of Arak University of Medical Sciences and the necessary coordination,convenience sampling is done from all health centers affiliated to Arak University of Medical Sciences as well as Ayatollah Taleghani Health Center, so that the researcher (student) after attending the mentioned places Examines pregnant clients for inclusion criteria. .Classes are held in 5 sessions of 60 to 90 minutes per week for the intervention group in the pregnant classrooms of Ayatollah Taleghani Hospital and the control group does not receive any intervention. Blinding is single.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: gestational age 29-22 weeks and age 18-35 years. Exclusion criteria: unwillingness to continue participating in the study after the start of the study, absence of more than one session.
Intervention groups
The participants of the intervention group receive 5 sessions of 60 to 90 minutes once a week for the solution approach consultation in groups of 10 people. Individuals in the control group do not receive intervention.
Main outcome variables
pregnancy anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220125053827N1
Registration date: 2022-02-26, 1400/12/07
Registration timing: registered_while_recruiting

Last update: 2022-02-26, 1400/12/07
Update count: 0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Fatemeh Mazraeifarahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3425 3295
Email address
f.mazraeifarahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-27, 1400/11/07
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Solution-Focused group counseling on anxiety in pregnant women
Public title
Investigating the effect of Solution-Focused group counseling on anxiety in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18-35 years, at least fifth elementary education, gestational age (29-32) weeks, obtaining a score of 18 from the short form of the revised Pregnancy Anxiety Questionnaire Edition 2, singleton pregnancy, no history of infertility and use of assisted reproductive techniques , Pregnant mother's desire to participate in research, no smoking, alcohol and drug addiction, no history of hospitalization in the psychiatric ward, no use of psychiatric drugs at present and during the intervention, no use of propranolol, no participation in similar intervention , No occurrence of stressful events during the last 6 months, resident of Arak city and no diseases or medical records and disorders that make pregnancy high risk.
Exclusion criteria:
Reluctance to cooperate, absence from more than one session, experience of stressful events (death of a spouse, death of a loved one), occurrence of any complications that make pregnancy dangerous (gestational diabetes, preeclampsia, preterm (onset of labor pains before 37 weeks Complete pregnancy), bleeding, intrauterine death).
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the block randomization method will be used (20 to 4 blocks), in each block, two allocations for the control group and two allocations for the intervention group are considered. Random sequence generation will be done using the site (https://www.sealedenvelope.com) . The list of random allocation sequences is then made available to an individual outside the research team. As soon as a person is eligible to attend the study, the sampler contacts the person with the random assignment sequence and, in turn, according to the sequence list, gives the participants a code to enter the study, thus hiding the sequence. Will be the central method
Blinding (investigator's opinion)
Single blinded
Blinding description
Completion of the questionnaire in the post-test stage is done by interviewers who are unaware of how people are placed in the two groups and do not know the statistical consultant.
Placebo
Not used
Assignment
Other
Other design features
Examining the interventions performed to reduce pregnancy anxiety, whether solution-oriented, etc., it was found that in these studies, a specific population of pregnant women were studied, for example, Noli Par women who were afraid of childbirth or Noli Par women. Many of these studies also used general anxiety questionnaires to measure pregnancy anxiety, such as the Spielberger Anxiety Inventory, the Hamilton Anxiety Rating Scale, the Cohen Perceived Stress Scale, and the Beck General Anxiety Inventory. It is clear that the study of multiparous women, as a large proportion of pregnant women, has been neglected, while the results of a study showed that multiparous women were 36% more anxious than nulliparous women.Another important point is to use a special questionnaire to measure pregnancy anxiety. General Anxiety Questionnaires are designed to measure general anxiety and their items are not able to measure pregnancy-related anxiety. Therefore, there is a need to conduct studies that include women with multiple pregnancies and a specific questionnaire of appropriate pregnancy anxiety has been used. Therefore, in this study, the short form of the revised Pregnancy Anxiety Questionnaire Edition 2 (PRAQ-R2) was used and the study population includes nulliparous and multiparred women.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Slaughterhouse Street, Shahid Vahidollah Rezaei Alley, Postal Code 3816787916
City
Arak
Province
Markazi
Postal code
3816787916
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IR.ARAKMU.REC.1400.277

Health conditions studied

1

Description of health condition studied
Pregnancy Anxiety
ICD-10 code
O99.345
ICD-10 code description
Other mental disorders complicating the puerperium

Primary outcomes

1

Description
Pregnancy Anxiety
Timepoint
Before and immediately after the intervention
Method of measurement
Using the Revised Pregnancy Anxiety Questionnaire Form 2 (PRAQ-R2)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Intervention group: The intervention group will receive 5 sessions of solution-oriented group counseling, one session per week on an even day of the week (Saturday or Monday or Wednesday) for 5 consecutive weeks. Each session will last 90 minutes. Since the consultation is held in groups, the number of people in each group is 10 and we will have a total of 4 groups of 10 people (40 people). Solution-oriented group counseling sessions will be in accordance with the solution-oriented treatment protocol (including: introduction - goal setting - eliminating the disruptive pattern of behavior with miraculous questions - creating solutions - consolidating solutions - summarizing and concluding) They do not receive any intervention.
Category
N/A

2

Description
Control group: The control group did not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers affiliated with Arak University of Medical Sciences and Ayatollah Taleghani Hospital
Full name of responsible person
Fatemeh Mazraei Farahani
Street address
Koshtargah street, Shahid Vahidollah Rezaei alley
City
Arak
Province
Markazi
Postal code
3816787916
Phone
+98 86 3425 3295
Email
f.mazraeifarahani@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamani
Street address
Sardasht Street
City
Arak
Province
Markazi
Postal code
3816787916
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
No
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No
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
Fatemeh Mazraei Farahani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Koshtargah Street Shahid Vahidolah Rezaei Ave
City
اراک
Province
Markazi
Postal code
3816787916
Phone
34253295
Email
f.mazraeifarahani@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
fatemeh mazraei farahani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
koshtargah street, Shahid Vahidollah Rezaei alley
City
Arak
Province
Markazi
Postal code
3816787916
Phone
+98 86 3425 3295
Email
f.mazraeifarahani@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Mazraei Farahani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Koshtargah Street Shahid Vahidolah Rezaei Ave
City
Arak
Province
Markazi
Postal code
3816787916
Phone
+98 86 3425 3295
Email
f.mazraeifarahani@arakmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Loading...