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

Amasya University

Status: Completed

Conditions: Pregnancy Related; Anxiety

Treatments: Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention; Behavioral: Deep Relaxation Exercises intervention; Other: No Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05447000

Amasya University

Details and patient eligibility

About

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".

Full 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.

Enrollment: 95 patients

Sex: Female

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 3 patient groups

Mindfullness Based Stress Reduction

Experimental group

Description:

Mindfullness Based Stress Reduction (MBSR) therapy

Treatment:

Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention

Deep Relaxation Exercises

Experimental group

Description:

Deep Relaxation Exercises therapy

Treatment:

Behavioral: Deep Relaxation Exercises intervention

Control

Other group

Description:

Control

Treatment:

Other: No Intervention