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

Primary Purpose

Anxiety, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mindfullness Based Stress Reduction (MBSR) intervention
Deep Relaxation Exercises intervention
No Intervention
Sponsored by
Amasya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Having internet access,
  • Without any diagnosed psychiatric health problem,
  • At 10-28 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

Sites / Locations

  • Amasya University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Mindfullness Based Stress Reduction

Deep Relaxation Exercises

Control

Arm Description

Mindfullness Based Stress Reduction (MBSR) therapy

Deep Relaxation Exercises therapy

Control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
February 28, 2023
Sponsor
Amasya University
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1. Study Identification

Unique Protocol Identification Number
NCT05447000
Brief Title
The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises in Pregnant Women
Official Title
The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises on Pregnancy-Related Anxiety Level
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
November 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amasya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pregnancy Related

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfullness Based Stress Reduction
Arm Type
Experimental
Arm Description
Mindfullness Based Stress Reduction (MBSR) therapy
Arm Title
Deep Relaxation Exercises
Arm Type
Experimental
Arm Description
Deep Relaxation Exercises therapy
Arm Title
Control
Arm Type
Other
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Mindfullness Based Stress Reduction (MBSR) intervention
Intervention Description
Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring anxiety levels with mindfulness program
Intervention Type
Behavioral
Intervention Name(s)
Deep Relaxation Exercises intervention
Intervention Description
Deep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
No Intervention
Primary Outcome Measure Information:
Title
Pregnancy-Related Anxiety Scale
Description
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.
Time Frame
At the end of the 1 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Amasya University
City
Amasya
ZIP/Postal Code
05000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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