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Investigating the effectiveness of psychological intervention in the first semester on some health parameters at the end of the second trimester

Protocol summary

Study aim
Determination of the effect of psychological intervention in the first trimester on some health indicators at the end of the second trimester in women undergoing pregnancy care in private centers in Kerman, 2023-2024
Design
Clinical trial work with control group, with parallel groups, without blinding, randomized, is performed on 60 pregnant women. Available sampling and limited randomization method according to the law of random allocation in two similar groups (each group of 30 people) will be intervention and control. For this purpose, using random allocation software, a random sequence will be generated based on two intervention and control groups, then based on this generated sequence, people will be allocated to two intervention and control groups.
Settings and conduct
Available sampling, intervention in first-trimester primigravida pregnant women, in Mehrgan Hospital meeting hall
Participants/Inclusion and exclusion criteria
primigravida pregnant women up to 9 weeks gestational age, age 18-45 years, singleton pregnancy, non-participation in other psychotherapy sessions, unwanted pregnancy, people fluent in Farsi language, absence of any underlying and chronic diseases and not taking sedative drugs and not being infected to other psychological diseases before starting the intervention
Intervention groups
Psychological intervention in 3 sessions (60-90 minutes) during 3 weeks (once a week) for the intervention group in Mehrgan Hospital meeting hall by a master's student in counseling in midwifery and trained and proficient to implement psychological intervention. The control group did not receive any intervention and received routine pregnancy care.
Main outcome variables
Reducing anxiety and stress, improving sleep quality, blood pressure, thyroid, fasting blood sugar

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170611034452N17
Registration date: 2023-12-11, 1402/09/20
Registration timing: prospective

Last update: 2023-12-11, 1402/09/20
Update count: 0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of psychological intervention in the first semester on some health parameters at the end of the second trimester
Public title
Investigating the effectivemess of psychological intervention on some health factors of pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
primigravida pregnant women up to 9 weeks gestational age age 18-45 years singleton pregnancy non-participation in other psychotherapy sessions unwanted pregnancy fluency in persian language absence of any underlying and chronic diseases non-use of sedatives non-infection of Other psychological diseases before starting the intervention
Exclusion criteria:
Loss of pregnancy during the intervention occurrence of a traumatizing event such as the loss of loved ones absence from a session of the intervention
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)
Randomized
Randomization description
In this intervention, 60 pregnant women who meet the inclusion criteria for entering the study from among the referrals to two gynecologists of private centers in Kerman in the time period until the sample size is reached (available sampling) with the limited randomization method according to the law of random allocation in two similar group (each group of 30 people) is placed in intervention and control. For this purpose, using random allocation software, a random sequence is generated based on two intervention and control groups, then based on this generated sequence, people are allocated to two intervention and control groups.
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
Research Ethics Committees of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway,Kerman ,Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-11-04, 1402/08/13
Ethics committee reference number
IR.KMU.REC.1402.290

Health conditions studied

1

Description of health condition studied
Psychological intervention in primigravida pregnant women without underlying disease
ICD-10 code
O09.31
ICD-10 code description
Supervision of pregnancy with insufficient antenatal care, first trimester

Primary outcomes

1

Description
Anxiety state of people
Timepoint
Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy
Method of measurement
Pregnancy-related anxiety questionnaire and Penn State worry questionnaire

2

Description
sleep quality
Timepoint
Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy
Method of measurement
PSQI sleep quality questionnaire

3

Description
blood pressure
Timepoint
Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy
Method of measurement
Sphygmomanometer

4

Description
FBS
Timepoint
Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy
Method of measurement
Blood samples from people and in the laboratory

5

Description
Thyroid disorders
Timepoint
Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy
Method of measurement
Blood samples from people and in the laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 pregnant women who meet the inclusion criteria in the first trimester receive three sessions of psychological intervention, each session lasting 60-90 minutes and one session per week.
Category
Behavior

2

Description
Control group: 30 pregnant women who are in the control group do not receive any psychological intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehregan hospital
Full name of responsible person
Fereshte Mohseni
Street address
3 Kamyab;kerman
City
Kerman
Province
Kerman
Postal code
7615784336
Phone
+98 34 9100 1818
Email
fereshte.mohseni1997@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway,Kerman ,Iran Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
intdep2@gmail.com
Web page address
http://vresearch.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
associate prof
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
a.ahmadi@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
associate prof
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
a.ahmadi@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nursing and midwifery faculty, Medical Sciences Pardis, Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5205
Fax
+98 34 3132 5218
Email
a.ahmadi@kmu.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
with previous agreement with the corresponding author
From where data/document is obtainable
email address
What processes are involved for a request to access data/document
email address
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