Association the effect of mindfulness-based stress reduction (MBSR) intervention on fear of childbirth in first-time pregnant women referring to comprehensive health centers in Sabzevar city
Determination of effect of mindfulness-based stress reduction (MBSR) intervention on fear of childbirth in first-time pregnant women referring to comprehensive health centers in Sabzevar city
Design
A randomized, blinded, control clinical trial on 60 first-time pregnant women.
Settings and conduct
People who fear score between 38 to 84 would be entered to the study. Then 60 participants divided two groups (intervention or control) by using of random allocation table or reliable online software. Results' assessors (clinical psychologist and statistic advisor) and participants are blinded. Intervention group attend both preparation classes for childbirth and MBSR classes. Program is based on John Cabat Zin protcol for pregnant women and location is Mobini Shahidan Hospitan in Sabzevar.
Participants/Inclusion and exclusion criteria
18-35 years old 2.Desire to attend in research; Score of fear of childbirth<85 based on Wijma Questionnaire; First-time pregnancy and without history of abortion and ectopic pregnancy; Gestational age between 26 to 30 weeks; Literate of reading and writing; Single pregnancy; Sonography that shows fetus is normal; Available to groups meeting; No history of mental substance during last 6 months; No history of mental disease during last 6 months
Intervention groups
Women 18 to 35 years old with gestational age between 26 to 30 weeks.
Main outcome variables
1- Determination of score of Fear of childbirth in intervention group before and after study
2- Determination of score of Fear of childbirth in control group before and after study
3- Determination of score of Fear of childbirth, 4 weeks after intervention in intervention and control groups
4- Comparison of score of Fear of childbirth, before, immediately after and 4 weeks after intervention in intervention and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091229002924N4
Registration date:2026-03-15, 1404/12/24
Registration timing:prospective
Last update:2026-03-15, 1404/12/24
Update count:1
Registration date
2026-03-15, 1404/12/24
Registrant information
Name
Maryam Hassanzadeh Bashtian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3151 1206
Email address
m.h.bashtian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-19, 1405/01/30
Expected recruitment end date
2026-08-21, 1405/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Association the effect of mindfulness-based stress reduction (MBSR) intervention on fear of childbirth in first-time pregnant women referring to comprehensive health centers in Sabzevar city
Public title
The effect of mindfulness-based stress reduction (MBSR) intervention on fear of childbirth in first-time pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1.18-35 years old 2.Desire to attend in research 3. Score of fear of childbirth<85 based on Wijma Questionnaire 4. First-time pregnancy and without history of abortion and ectopic pregnancy 5. Gestational age between 26 to 30 weeks 6. literate of reading and writing 7. Single pregnancy 8. Sonography that shows fetus is normal 9. Available to groups meeting 10. No history of mental substance during last 6 months 11. No history of mental disease during last 6 months
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants divided to two groups (intervention and control) based on random allocation table or online reliable software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation process to study groups is secret and results assessors (clinical psychologist and statistic advisor) and participants will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committee of North Khorasan University of Medical Sciences.
Street address
Department of Midwifery, School of nursing and midwifery, Shahriar Street, Bojnord, North Khorasan, Iran
City
Bojnurd
Province
North Khorasan
Postal code
96786-94176
Approval date
2026-02-24, 1404/12/05
Ethics committee reference number
IR.NKUMS.REC.1404.190
Health conditions studied
1
Description of health condition studied
First-time pregnant women during 26 to 30 weeks pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of childbirth in FOC Wijma questionnaire
Timepoint
Foear of childbirth in first (before intervention), after 8 mindfulness sessions and 4 weeks after that
Department of Midwifery, School of Nursing and Midwifery, Shahriyar street, Bojnurd, North Khorasan, Iran.
City
Bojnurd
Province
North Khorasan
Postal code
96786-94176
Phone
+98 58 3229 7097
Email
m.hasanzadeh@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Omid Toopchian
Street address
Research and Technology Deputy, After Imam Ali (A.S.) Special Clinic, Shahriar Street, Bojnord, North Khorasan, Iran
City
Bojnurd
Province
North Khorasan
Postal code
9417694780
Phone
+98 58 3151 1420
Email
modiriat.pajoheshi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Hassanzadeh Bashtian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
After Imam Ali (A.S.) Special Clinic, Shahriar Street, Bojnord, North Khorasan, Iran
City
Bojnurd
Province
North Khorasan
Postal code
96786-94176
Phone
+98 58 3229 7096
Email
m.hasanzadeh@nkums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Hassanzadeh Bashtian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
After Imam Ali (A.S.) Special Clinic, Shahriar Street, Bojnord, North Khorasan, Iran
City
Bojnurd
Province
North Khorasan
Postal code
96786-94176
Phone
+98 58 3229 7096
Email
m.hasanzadeh@nkums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Maryam Hassanzadeh Bashtian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
After Imam Ali (A.S.) Special Clinic, Shahriar Street, Bojnord, North Khorasan, Iran
City
Bojnurd
Province
North Khorasan
Postal code
96786-94176
Phone
+98 58 3229 7096
Email
m.hasanzadeh@nkums.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Since article result in study would be published. so, the datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
When the data will become available and for how long
Start for datasets available would be 6 months after article publish.
To whom data/document is available
Datasets would be available for researchers in Universities and Scientifice institutions.
Under which criteria data/document could be used
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
From where data/document is obtainable
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
What processes are involved for a request to access data/document
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request after one month from written requset by email.