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Clinical Trials/NCT05447000
NCT05447000
Completed
Not Applicable

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

Amasya University1 site in 1 country95 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Amasya University
Enrollment
95
Locations
1
Primary Endpoint
Pregnancy-Related Anxiety Scale
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
November 24, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emine Akca

Assist. Prof. Dr. in the Amasya University Midwifery Department

Amasya University

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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