The effectiveness of mindfulness-based stress reduction (MBSR) counseling on maternal-fetal attachment in women with a fear of childbirth
Design
This randomized clinical trial is non-blindeda with a parallel design and control group. This randomized study will be conducted on 60 eligible pregnant women with a fear of childbirth. A randomized block design will be used for randomization, and participants will be assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at the Hafezieh Health Center in Kermanshah, is non-blinded. Coordination for the implementation of the study will be done during morning administrative hours in coordination with the relevant officials at the health center. At the beginning of the study, a demographic information form and a childbirth fear questionnaire will be provided to participants to identify pregnant women who have a fear of childbirth
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Pregnant mothers with a gestational age of more than 20 weeks with singletons; Obtaining a score of 66-84 on the fear of childbirth questionnaire; Wanting to get pregnant
Exclusion criteria: History of known mental disorders; History of taking neuroleptic drugs; History of addiction; History of infertility
Intervention groups
The intervention group will receive 8 mindfulness group counseling sessions based on stress reduction in person, and for 60-90 minutes. The control group will receive only routine care according to national guidelines.
Main outcome variables
Mother's attachment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N254
Registration date:2025-06-16, 1404/03/26
Registration timing:prospective
Last update:2025-06-16, 1404/03/26
Update count:0
Registration date
2025-06-16, 1404/03/26
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-20, 1404/03/30
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based stress reduction counseling on maternal-fetal attachment in women with fear of childbirth
Public title
The effectiveness of mindfulness on maternal-fetal attachment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Pregnant mothers with a gestational age of more than 20 weeks with singletons
Obtaining a score of 66-84 on the fear of childbirth questionnaire
Wanting to get pregnant
Exclusion criteria:
History of known mental disorders
History of taking neuroleptic drugs
History of addiction
History of infertility
Age
No age limit
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
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2025-05-31, 1404/03/10
Ethics committee reference number
IR.KUMS.REC.1404.161
Health conditions studied
1
Description of health condition studied
Childbirth of fear
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Using the Maternal Attachment Questionnaire
Timepoint
Before the start of the intervention, after the intervention and four weeks after the end of the intervention
Method of measurement
Using the maternal-fetal attachment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 8 mindfulness group counseling sessions based on stress reduction in person and for 60-90 minutes.
Category
Treatment - Other
2
Description
The control group will receive only routine care according to national guidelines. Routine treatment includes at least 8 periodic visits from the beginning of pregnancy until delivery, during which the mother's physical and psychological condition is assessed, vital signs are monitored, fetal growth is measured, laboratory screenings and necessary ultrasounds are performed, nutritional counseling, and childbirth preparation classes are provided.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafeziyeh Health Center
Full name of responsible person
Zahra Shokoohi
Street address
Next to the Girls' School, Hafeziyeh Street
City
Kermanshah
Province
Kermanshah
Postal code
6725813241
Phone
+98 83 3838 4632
Email
zahrashokoohi3@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Zohreh Rahimi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
Zrahimi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mastane Kamromanesh
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
kamravamanesh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mastaneh Kamrvamanesh
Position
Faculty member of the university
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
kamravamanesh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mastaneh Kamrvamanesh
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
kamravamanesh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD