The Effect of Web-based Mindfulness-based Stress Reduction Program on Pregnant Women
1 other identifier
interventional
89
1 country
1
Brief Summary
Pregnancy is a period in which physiological and psychological changes are experienced and discomforts related to these changes are observed, and comfort is affected for the pregnant. However, fetal health concern refers to the concern of the expectant mother about the health of her developing fetus. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable anxiety
Started Jul 2022
Shorter than P25 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 1, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedFebruary 24, 2023
February 1, 2023
3 months
June 28, 2022
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prenatal Comfort Scale
The minimum score that can be obtained from the scale is "0", the maximum score is "75", and as the score obtained from the scale increases, prenatal comfort levels also increase.
At the end of the 2 months
Fetal Health Anxiety Inventory
The minimum score that can be obtained from the scale is "0", the maximum score is "42", and as the score obtained from the scale increases, fetal health anxiety levels also increase.
At the end of the 2 months
Study Arms (2)
Mindfullness Based Stress Reduction
EXPERIMENTALMindfullness Based Stress Reduction (MBSR) therapy
Control
NO INTERVENTIONControl
Interventions
Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program
Eligibility Criteria
You may qualify if:
- Not having any diagnosed psychiatric disease,
- Literate,
- Using a smart phone,
- With internet access
- Having a headset accessory for phone calls,
- Pregnant women who voluntarily agreed to participate in the study
You may not qualify if:
- Filling in the questionnaire form incompletely,
- Pregnant women with communication barriers and mental disabilities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amasya University
Amasya, 05000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof. Dr. in the Amasya University Midwifery Department
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 1, 2022
Study Start
July 1, 2022
Primary Completion
October 1, 2022
Study Completion
November 1, 2022
Last Updated
February 24, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share