Clinical trial NCT05447000: The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises in Pregnant Women
Official title: The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises on Pregnancy-Related Anxiety Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pregnancy Related
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 95
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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".

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy-Related Anxiety Scale
timeFrame: At the end of the 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University
Study officials:
References: