The effect of mindfulness-based cognitive behavioral therapy on childbearing attitudes in single-child working women
Design
The clinical trial has a randomized control group, an intervention and a control group of 36 people each, randomization by 4 blocks method.
Settings and conduct
The place of the study is the health center in the east of Ahvaz city. The sample of the research is working women with one child referring to the health center who meet the conditions to entering the study. The participants are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the method of cognitive behavioral therapy based on mindfulness (MBCT) is used. The treatment program will be provided by the researcher in the form of an 8-session program over 8 weeks. Meetings will be held in groups. Contents and assignments will be presented to the intervention group on a weekly basis. The way to follow up the samples in 3 stages is to fill the questionnaire in the first session (pre-test), the last session (post-test) and one month after the last training session.
Participants/Inclusion and exclusion criteria
Entry conditions: being married; being between the ages of 18 and 44 years old 3; reading and writing literacy; working women; single-child women.
Conditions for non-entry: having a child with a disability; secondary infertility of a woman or her husband; having a serious physical illness that prevents fertility.
Intervention groups
Participants are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the method of mindfulness based cognitive behavioral therapy (MBCT) is used.
Main outcome variables
Childbearing attitude
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230710058735N1
Registration date:2023-07-18, 1402/04/27
Registration timing:prospective
Last update:2023-07-18, 1402/04/27
Update count:0
Registration date
2023-07-18, 1402/04/27
Registrant information
Name
Mitra Ahmadfakhrodin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3224 7361
Email address
afam17022@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based cognitive-behavioral therapy on fertility attitude in single-child working women
Public title
The effect of mindfulness-based cognitive-behavioral therapy on fertility attitude's women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being married
Single-child women
Literacy for reading and writing
Having the age of 18 to 44 years
Employment of women
Low score based on attitude towards Childbearing questionnaire: less than 11
Exclusion criteria:
Secondary infertility of wife or husband
Having mental disorders in a woman or her husband
Having a serious physical illness that prevents fertility
Husband's activity in jobs that require periodic migration.
Having a child with a disability
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation, considering that we have two intervention and control groups, we will use a block of 4. In order to determine the allocation sequence using the 4 block method, random allocation sequence generation software will be used. In order to hide the sequence of allocation, the papers identifying the group of people are placed inside the envelopes in the opaque package and coded in the same order.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of research and technology, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-06-24, 1402/04/03
Ethics committee reference number
IR.AJUMS.REC.1402.195
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fertility Attitude Score in Fertility Attitude Questionnaire
Timepoint
The beginning of the study (pre-test), the end of the study (post-test), 1 month after the last session.
Method of measurement
Fertility Attitude Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single-child working women receiving mindfulness-based cognitive behavioral therapy. Mindfulness-based cognitive behavioral therapy (MBCT) is an approach to psychotherapy that uses cognitive behavioral therapy (CBT) methods along with mindfulness meditation practices and similar psychological strategies. In MBCT, mindfulness is based on 4 principles including Body awareness (body position and body movement/activity), body sensations (including those related to emotions), mental states (including emotional states) and mental content (thoughts, images) are taught. In this study, the participants who meet the study entry criteria are randomly assigned to two control and intervention groups. In the control group, there is no intervention, and in the intervention group, the method of cognitive therapy based on mindfulness (MBCT) is used. Before starting the treatment program, the training certificate of the MBCT course will be received and attached to the study, then the cognitive therapy program based on mindfulness for fertility attitude in the form of an 8-session program during 8 weeks by The researcher will be presented. Meetings will be held in groups. Contents and assignments will be presented to the people of the intervention group on a weekly basis. It will be considered that the participants, whenever they have a problem in doing the assignments, have more interaction with the researcher in person or virtually to ensure the correctness of the assignments. How to follow up the samples in 4 steps by filling out the questionnaire The first session (pre-test), the last session (post-test),and one month after the last session after the last training session.
Category
Treatment - Other
2
Description
Control group: Single-child working women without receiving cognitive behavioral therapy based on mindfulness
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
East Ahvaz Health Center
Full name of responsible person
Amralah Mardani
Street address
in front of Haft Tir Park - Shahid Rostagari street - Ayatollah Behbahani highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sahand Jorfi
Street address
Deputy of research and technology, Esfand Ave., Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
jorfi-s@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Mitratadayon2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Mitratadayon2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Mitratadayon2000@yahoo.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
All data and results of the research will be provided to Jundishapur University of Medical Sciences Ahvaz
When the data will become available and for how long
It will be possible to access the research documents six months after the final statistical analysis.
To whom data/document is available
The data will be available only for the use of researchers of academic institutions
Under which criteria data/document could be used
In order to promote childbearing
From where data/document is obtainable
In order to receive the data, people can refer to the main executive of the project, Mitra Tadayon Najafabadi, a member of the academic staff of Jundishapur University of Medical Sciences, Ahvaz.
What processes are involved for a request to access data/document
After obtaining the necessary permits from the Jundishapur University of Medical Sciences and the Vicechancellor of Research and Technology of this university, the applicant can proceed to receive the documents.