The study of the effectiveness of midwifery counseling on pregnancy anxiety and over-anxiety with the "mindfulness approach" among women who have become pregnant through assisted reproductive technologies.
This study aims to determine the effectiveness of midwifery counseling with a mindfulness approach on pregnancy anxiety and over-anxiety of pregnant women with a history of infertility (conceived through assisted reproductive methods).
Design
Clinical trial including control group, parallel groups, randomized will be conducted on 70 cases without blinding. A randomizer will be employed for randomization.
Settings and conduct
This trial will be conducted on two groups of eligible pregnant women. Women with an anxiety score of 60 or more and an over-anxiety score of 14 or more will be allocated to two groups "the intervention" and "the control" by random block method. For the intervention group, mindfulness group counseling will be done during 8 sessions at the Comprehensive Cealth Center in Tehran in 2023. The control group will receive routine prenatal care. Vandenberg's pregnancy anxiety and over-anxiety questionnaire will be completed by interview before, immediately and four weeks after the intervention for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient's willingness to particioate. Pregnant women aged 20-490. History of primary or secondary infertility. Pregnancy through assisted reproductive methods. Gestational age of 24 to 14 weeks. Pregnancy anxiety score 60, or more. Research score of 14 and more
Non-inclusion criteria:
Pregnant women with any history of psychiatric diseases or psychological treatment. Diseases such as diabetes. Need for special care. Severe mental crisis during the last 3 months.
Intervention groups
For the intervention group, mindfulness counseling will be done during 8 face-to-face sessions in Tehran in 2023. The control group will receive routine prenatal care.
Main outcome variables
Pregnancy anxiety and over-anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230912059414N1
Registration date:2023-10-17, 1402/07/25
Registration timing:prospective
Last update:2023-10-17, 1402/07/25
Update count:0
Registration date
2023-10-17, 1402/07/25
Registrant information
Name
Fariba Mohamadyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7727 2164
Email address
faribamohamadyariii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effectiveness of midwifery counseling on pregnancy anxiety and over-anxiety with the "mindfulness approach" among women who have become pregnant through assisted reproductive technologies.
Public title
The study of the effectiveness of midwifery counseling on pregnancy anxiety and excessive worrying with the "mindfulness approach" among women who have become pregnant through assisted reproductive technologies.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's willingness to paticipate
Pregnant women aged 20-49
Women with a history of primary or secondary infertility
Having at least reading and writing ability
Having conceived with assisted reproductive methods
Gestational age of 14 to 24 weeks
Getting pregnancy anxiety score of 60, or more
Getting an excessive worring score of 14, or more
Exclusion criteria:
Women with any history of psychiatric disorder and psychological treatment
Developing certain medical diseases such as diabetes, cardiovascular problems
The need for special care such as absolute rest due to pregnancy complications
Fatal abnormalities
Having experienced a severe emotional crisis over the last 3 months, such as bereavement, according to the person's statement
Age
From 20 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Quadruple blocks. In this study, we will use the Restricted randomization method of block randomization. The size of all blocks is equal and we in this two-group experiment of 4 blocks (including 2 participants in We will have an intervention group and 2 participants in the control group). The method of hiding the sequence of allocating white envelopes is used. Using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists and with the help of the methodology consultant, the allocation sequence was generated.
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 Shahrood University of Medical Sciences
Street address
Shahrood University of Medical Sciences and Health Care Services, 7th Tir Square, Shahrood, Iran
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Approval date
2023-09-11, 1402/06/20
Ethics committee reference number
IR.SHMU.REC.1402.090
Health conditions studied
1
Description of health condition studied
Pregnancy anxiety and Meta worry of pregnant women with assisted reproduction methods
ICD-10 code
F53
ICD-10 code description
Puerperal psychosis
Primary outcomes
1
Description
Pregnancy anxiety of women who have become pregnant through assisted reproduction methods
Timepoint
Completing the Vandenberg pregnancy anxiety questionnaire by the pregnant woman before the start of counseling sessions and then immediately after the end of the counseling sessions and 4 weeks after the sessions.
Method of measurement
Vandenberg pregnancy anxiety questionnaire
2
Description
Meta worry of pregnant women with assisted reproduction methods
Timepoint
Filling out the meta worry questionnaire by the pregnant woman before the start of counseling sessions and then immediately after the end of the counseling sessions and 4 weeks after the sessions.
Method of measurement
Meta worry questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: eight midwifery consultation sessions with the approach of mindfulness
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility treatment centers in Tehran
Full name of responsible person
Fariba Mohamadyari
Street address
Unit 2, First Floor, No. 2, Ario Center Complex, Jafarian Alley, Shamshiri Street, South Mehrabad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3614773943
Phone
+98 21 6660 6469
Email
faribamohamadyariii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
Shahrood University of Medical Sciences and Health Care Services, 7th Tir Square, Shahrood, Iran
City
Shahrood
Province
Semnan
Postal code
-3614773943
Phone
+98 23 3239 5054
Email
info@shmu.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Fariba Mohamadyari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood University of Medical Sciences and Health Care Services, 7th Tir Square, Shahrood, Iran
City
Tehran
Province
Tehran
Postal code
1475684143
Phone
+98 21 7727 2164
Email
faribamohamadyariii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fariba Mohamadyari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 27, Khodadoost Alley, 2nd South Sixteen Meter St , Jannat Abad Central
City
Teran
Province
Tehran
Postal code
1475684143
Phone
+98 21 7727 2164
Email
faribamohamadyariii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fariba Mohamadyari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 27, Khodadoost Alley, 2nd South Sixteen Meter St , Jannat Abad Central
City
Tehran
Province
Tehran
Postal code
1475684143
Phone
+98 21 7727 2164
Email
faribamohamadyariii@gmail.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
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
It can be shared after making participants unidentified
When the data will become available and for how long
After defending and passing the master's thesis
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Clinical research
From where data/document is obtainable
Administrator's email
What processes are involved for a request to access data/document
After authentication of the person, who have requested and in what field it will be applied will be sent as soon as possible