Determining the effect of Mindfulness-based Cognitive Behavioral Therapy on Fear of childbirth in Teenage Primigravida Women
Design
A randomized controlled clinical trial with parallel groups, Randomized using block randomization method. Sample size will be 112 (56 persons per group)
Settings and conduct
The place of the study is the healthcare centers of Shush city.The study population is teenage primigravida women. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: conditions: age range 13-19 years; pregnancy age 28 weeks; low-risk pregnancy; and singleton. Non-inclusion criteria: history of receiving mindfulness training; facing major stress due to unforeseen events; addiction to alcohol, narcotics and other psychoactive drugs.
Intervention groups
In the control group, there is no intervention. In the intervention group, the method of mindfulness based cognitive behavioral therapy is used.
Main outcome variables
Fear of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230716058809N1
Registration date:2023-07-30, 1402/05/08
Registration timing:prospective
Last update:2023-07-30, 1402/05/08
Update count:0
Registration date
2023-07-30, 1402/05/08
Registrant information
Name
Leila Hasanvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4262 6955
Email address
leilahasanvand2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-20, 1403/01/01
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 Fear of childbirth in Teenage Primigravida Women
Public title
The effect of Mindfulness-based Cognitive Behavioral Therapy on Fear of childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 13-19 years
Primigravida women
Gestation age 28 weeks
Literacy for reading and writing
Singleton pregnancy
Low risk pregnancy
Obtaining a moderate to severe fear of childbirth score (score 38-84 from Vijma questionnaire version A)
Informed willingness to participate in research
Exclusion criteria:
History of receiving mindfulness training
Facing major stress caused by unforeseen events
Addiction to alcohol, drugs and other psychoactive drugs
Age
From 13 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
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 size 4. In order to determine the allocation sequence using the block randomization 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.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-07-08, 1402/04/17
Ethics committee reference number
IR.AJUMS.REC.1402.226
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of childbirth
Timepoint
The beginning of the study (pre-test), the end of the study (post-test), 1 month after the last session.
Method of measurement
Vijma standard fear of childbirth questionnaire version A and version B
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teenage primigravida 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. 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.
Category
Treatment - Other
2
Description
Control group: Teenage primigravida women, for whom no intervention is performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shush City Health Center
Full name of responsible person
Amin Hejazi
Street address
In front of the post office; Saat square
City
Shush
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
khz-healthcenter@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.
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
Mina Iravani
Position
Associate Professor
Latest degree
Ph.D.
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
minairavani2004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate professor
Latest degree
Ph.D.
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
minairavani2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Associate professor
Latest degree
Ph.D.
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
minairavani2004@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 Ahvaz Jundishapur University of Medical Sciences
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 conduct similar research
From where data/document is obtainable
In order to receive the data, people can refer to the main executive of the project, Dr. Mina Iravani, 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.