The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises in Pregnant Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The aim of this study, which was conducted to determine the effects of mindfulness practices and deep relaxation exercises on the level of pregnancy-related anxiety, is to create intervention programs compatible with the prenatal period and to contribute to the improvement of pregnancy outcomes. First of all, a total of 111 pregnant women (37 mindfulness based stress reduction program, 37 deep relaxation exercises and 37 control) are planned to be included in the study. However, we recalculated the power analysis with a reference study after obtaining approval and before starting the study. With the calculation we made with the reference study, we determined our final sample number as 102 pregnant women (34 individuals for the mindfulness meditation group, 34 individuals for the deep relaxation exercises group, and 34 individuals for the control group). Data collected with the Personal Description Form, and The Pregnancy-related Anxiety Questionnaire-Revised 2. Mindfulness and deep relaxation practices was applied by midwives who are experts in their fields who are certified in these fields.

Official Title
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The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises on Pregnancy-Related Anxiety Level

Conditions
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Anxiety, Pregnancy Related

Intervention / Treatment
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* Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention
* Behavioral: Deep Relaxation Exercises intervention
* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -Mental disabilities

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfullness Based Stress Reduction<br>Mindfullness Based Stress Reduction (MBSR) therapy | Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention<br>* Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring anxiety levels with mindfulness program<br>|
| Experimental: Deep Relaxation Exercises<br>Deep Relaxation Exercises therapy | Behavioral: Deep Relaxation Exercises intervention<br>* Deep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention<br>|
| Other: Control<br>Control | Other: No Intervention<br>* No Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |