The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises in Pregnant Women
1 other identifier
interventional
95
1 country
1
Brief Summary
Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. Data collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2".
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 Aug 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
July 1, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2022
CompletedMarch 2, 2023
February 1, 2023
3 months
July 1, 2022
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy-Related Anxiety Scale
For primiparas, a minimum of 11 points and a maximum of 55 points is obtained, and for multipars, a minimum of 10 and a maximum of 50 points are obtained. As the score obtained from the scale increases, it is accepted that the level of anxiety in pregnancy is higher.
At the end of the 1 months
Study Arms (3)
Mindfullness Based Stress Reduction
EXPERIMENTALMindfullness Based Stress Reduction (MBSR) therapy
Deep Relaxation Exercises
EXPERIMENTALDeep Relaxation Exercises therapy
Control
OTHERControl
Interventions
Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring anxiety levels with mindfulness program
Deep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention
Eligibility Criteria
You may qualify if:
- Having internet access,
- Without any diagnosed psychiatric health problem,
- At 12-24 weeks of gestation,
- There is no risk factor in pregnancy,
- Literate,
- Using smart phone,
- Having a headset accessory for phone calls,
- Pregnant women who voluntarily agreed to participate in the study
You may not qualify if:
- Mental disabilities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amasya University
Amasya, 05000, Turkey (Türkiye)
Related Publications (1)
Gokbulut N, Cengizhan SO, Akca EI, Ceran E. The effects of a mindfulness-based stress reduction program and deep relaxation exercises on pregnancy-related anxiety levels: A randomized controlled trial. Int J Nurs Pract. 2024 Oct;30(5):e13238. doi: 10.1111/ijn.13238. Epub 2024 Jan 26.
PMID: 38279199DERIVED
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
July 1, 2022
First Posted
July 7, 2022
Study Start
August 1, 2022
Primary Completion
October 15, 2022
Study Completion
November 24, 2022
Last Updated
March 2, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share