Protocol summary
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Study aim
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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
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Design
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A randomized, blinded, control clinical trial on 60 first-time pregnant women.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Women 18 to 35 years old with gestational age between 26 to 30 weeks.
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Main outcome variables
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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
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Reason for update
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Since the sampling for this study was conducted at Shahidan Mobini Hospital in Sabzevar, and the clinical trial registration took place during the last week of Esfand (mid-March) when the relevant authorities were unavailable, only the hospital name was listed in the sampling location field, while the rest of the address was entered based on the originating university (North Khorasan). We now need to correct the university listed (Sabzevar)for the sampling site.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20091229002924N4
Registration date:
2026-03-15, 1404/12/24
Registration timing:
prospective
Last update:
2026-05-13, 1405/02/23
Update count:
1
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Registration date
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2026-03-15, 1404/12/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2026-04-19, 1405/01/30
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Expected recruitment end date
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2026-08-21, 1405/05/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The effect of mindfulness-based stress reduction (MBSR) intervention on fear of childbirth in first-time pregnant women
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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:
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants divided to two groups (intervention and control) based on random allocation table or online reliable software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Allocation process to study groups is secret and results assessors (clinical psychologist and statistic advisor) and participants will be blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2026-02-24, 1404/12/05
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Ethics committee reference number
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IR.NKUMS.REC.1404.190
Health conditions studied
1
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Description of health condition studied
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First-time pregnant women during 26 to 30 weeks pregnancy
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Fear of childbirth in FOC Wijma questionnaire
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Timepoint
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Foear of childbirth in first (before intervention), after 8 mindfulness sessions and 4 weeks after that
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Method of measurement
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FOC Wijma questionnaire
Intervention groups
1
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Description
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Intervention group: First-time pregnant wonen recepiant 8 weeks mindfulness sessions
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bojnourd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Start for datasets available would be 6 months after article publish.
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To whom data/document is available
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Datasets would be available for researchers in Universities and Scientifice institutions.
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Under which criteria data/document could be used
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The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
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From where data/document is obtainable
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The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
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What processes are involved for a request to access data/document
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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.
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Comments
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