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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447000
• Other study ID #: Amasya University
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: November 24, 2022

Study information

• Verified date: February 2023
• Source: Amasya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: November 24, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pregnancy Related

Intervention

Behavioral:
• Mindfullness Based Stress Reduction (MBSR) intervention
Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring anxiety levels with mindfulness program
• Deep Relaxation Exercises intervention
Deep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Turkey	Amasya University	Amasya

Sponsors (1)

Lead Sponsor	Collaborator
Amasya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy-Related Anxiety Scale	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.	At the end of the 1 months