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

NCT ID: NCT05447000

Last Updated: 2023-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-11-24

Brief Summary

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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

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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.

Conditions

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Anxiety Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mindfullness Based Stress Reduction

Mindfullness Based Stress Reduction (MBSR) therapy

Group Type EXPERIMENTAL

Mindfullness Based Stress Reduction (MBSR) intervention

Intervention Type BEHAVIORAL

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

Deep Relaxation Exercises

Deep Relaxation Exercises therapy

Group Type EXPERIMENTAL

Deep Relaxation Exercises intervention

Intervention Type BEHAVIORAL

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

Control

Control

Group Type OTHER

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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Mindfullness Based Stress Reduction (MBSR) intervention

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

Intervention Type BEHAVIORAL

Deep Relaxation Exercises intervention

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

Intervention Type BEHAVIORAL

No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Amasya University

OTHER

Sponsor Role lead

Responsible Party

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Emine Akca

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amasya University

Amasya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Gokbulut N, Cengizhan SO, Akca EI, Ceran E. The effects of a mindfulness-based stress reduction program and deep relaxation exercises on pregnancy-related anxiety levels: A randomized controlled trial. Int J Nurs Pract. 2024 Oct;30(5):e13238. doi: 10.1111/ijn.13238. Epub 2024 Jan 26.

Reference Type DERIVED
PMID: 38279199 (View on PubMed)

Other Identifiers

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Amasya University

Identifier Type: -

Identifier Source: org_study_id

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