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Completed

NCT Number: NCT05447000

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

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".

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Key information

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Amasya University

Amasya, 05000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfullness Based Stress Reduction (MBSR) intervention

Behavioral

Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring anxiety levels with mindfulness program

Deep relaxation exercises intervention

Behavioral

Deep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention

No intervention

Other

No Intervention

Primary outcomes

  1. Pregnancy-Related Anxiety Scale

    Time frame: At the end of the 1 months

    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.

Sponsors and collaborators

Lead sponsor

Amasya University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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