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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05447000
Enrollment
95
Registered
2022-07-07
Start date
2022-08-01
Completion date
2022-11-24
Last updated
2023-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pregnancy Related

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.

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

OTHERNo Intervention

No Intervention

Sponsors

Amasya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pregnancy-Related Anxiety ScaleAt the end of the 1 monthsFor 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026