Protocol summary

Study aim
Determining the effect of group counseling based on behavioral cognitive behavioral therapy on anxiety and nausea and vomiting in pregnant women
Design
This study was designed as a randomized controlled trial with control
Settings and conduct
Group counseling for samples is performed in comprehensive urban health service centers in Tehran. ,
Participants/Inclusion and exclusion criteria
Criteria for entering the study: gestational age between 6 to 12 weeks, monogamy مادر مادر Mother's age between 18-18 years  Failure to receive psychological treatment in the last 6 months  Diagnosis of nausea and vomiting and pregnancy anxiety according to the above questionnaires Criteria for leaving the study: . Suffering from mental illness  History of nausea and vomiting before pregnancy  History of gastrointestinal diseases  Complications of pregnancy in the current pregnancy (high-risk pregnancies with symptoms of nausea and vomiting)  Consumption ﺩﺍﺭﻭﻫﺎﻱ Effective on anxiety and nausea and vomiting during pregnancy (such as: androsterone, dimenhydrinate, etc.)
Intervention groups
The Ordinary Midwifery Control Group will receive midwifery care in the covered centers, and the intervention group will participate in group counseling classes based on routine midwifery care based on cognitive-behavioral therapy in 6 90-minute counseling sessions for 10 7-person groups per week.
Main outcome variables
Pregnancy anxiety, nausea and ejaculation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200530047606N1
Registration date: 2020-06-10, 1399/03/21
Registration timing: registered_while_recruiting

Last update: 2020-06-10, 1399/03/21
Update count: 0
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Zohre Shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4440 8992
Email address
zshafiei49@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling based on cognitive-behavioral therapy on anxiety and nausea and vomiting in pregnant women
Public title
The effect of group counseling based on cognitive-behavioral therapy onanxiety and nausea and vomiting in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
pregnancy age between 6 to 12 weeks (common gestational age) based on the 2019 article by Shoorgashti et al. Single-throat (due to increased nausea and vomiting with increasing number of throats) Maternal age between 40-18 years (due to safer pregnancy) No psychological treatment in the last 6 months Diagnosis of nausea and vomiting and pregnancy anxiety according to the above questionnaires
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
In order to select the centers where sampling is performed, cluster random sampling method will be used, by selecting centers from different parts of the city that represent the region economically and socially. This means that the city is divided into 5 northwestern, northeastern, southwestern, southeastern and central regions, and a comprehensive health center will be selected from each region. In the next step, the selection of the subjects will be purposeful and based on the entry and exit criteria. In order to identify people who meet the criteria for entering the study and the initial selection of participants, demographic and fertility questionnaires, nausea and vomiting and pregnancy anxiety were presented to all pregnant mothers at 6-12 weeks who came to each center to receive normal pregnancy care. After reviewing the questionnaires, all pregnant mothers with nausea, vomiting, and anxiety were identified at the same time. A total of 136 people are randomly selected using a random number table. Then, in the next step, we will use the random allocation law method to assign 136 pregnant mothers to two control and intervention groups. So that already in each center, forThere are two groups of names, B and A, with 68 people for the intervention group and 68 for the control group. The letters are written on a piece of paper with the number of participants on a piece of paper, and by drawing lots, people select the paper without replacing it, then the created sequence will be recorded. In this way, infected women will be divided into two groups of 68 people (the group receiving the intervention) and the 68-person control group (the group that will receive the usual care during pregnancy).
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
Qazvin University of Medical Sciences Ethics Committee
Street address
Bahonar Boulevard. Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2020-01-08, 1398/10/18
Ethics committee reference number
IR.QUMS.REC.1398.266

Health conditions studied

1

Description of health condition studied
Anxiety, nausea and vomiting during pregnancy
ICD-10 code
ICD-10 code description
Anxiety، nausea ،pregnancy ،vomiting

Primary outcomes

1

Description
Pregnancy Anxiety
Timepoint
. Pregnancy between 6 and 12 weeks
Method of measurement
PRAQ-17

2

Description
Pregnancy nausea and vomiting
Timepoint
6Up to 12 weeks of pregnancy
Method of measurement
PUQE

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, 68 anxious pregnant women who have nausea and ejaculation of pregnancy and routine pregnancy care +6 sessions receive training based on cognitive-behavioral therapy.
Category
Behavior

2

Description
control group: 68 anxious pregnant women who have nausea and vomiting during pregnancy and receive routine pregnancy care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
مراکز جامع سلامت شهر تهران
Full name of responsible person
Zohreh Shafiei
Street address
South Shahran, next to Maaref Cultural Center, No. 55, Unit13
City
Tehran
Province
Tehran
Postal code
1474953121
Phone
+98 21 4435 8133
Email
zshafiei49@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Tehran
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zohreh Shafiei
Position
Senior Midwifery Counseling Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahonar Blvd., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
zshafiei49@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zohreh Shafiei
Position
Senior Midwifery Counseling Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
zshafiei49@yahoo.com
Web page address
http://www.qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zohreh Shafiei
Position
Senior Midwifery Counseling Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
zshafiei49@yahoo.com
Web page address
http://www.qums.ac.ir

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In the form of an article
When the data will become available and for how long
6Months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutes and research students in this field.
Under which criteria data/document could be used
The use of results in articles and its comparison in new works is unrestricted
From where data/document is obtainable
zshafiei49@yahoo.com
What processes are involved for a request to access data/document
After the applicant's request via email, the necessary checks will be made and the information will be available shortly after confirmation.
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