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The Effect of Web-based Mindfulness-based Stress Reduction Program on Pregnant Women

Primary Purpose

Anxiety, Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mindfullness Based Stress Reduction (MBSR) intervention
Sponsored by
Amasya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Prenatal Comfort, MBSR

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Not having any diagnosed psychiatric disease,
  • Literate,
  • Using a smart phone,
  • With internet access
  • Having a headset accessory for phone calls,
  • Pregnant women who voluntarily agreed to participate in the study

Exclusion Criteria:

  • Filling in the questionnaire form incompletely,
  • Pregnant women with communication barriers and mental disabilities

Sites / Locations

  • Amasya University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfullness Based Stress Reduction

Control

Arm Description

Mindfullness Based Stress Reduction (MBSR) therapy

Control

Outcomes

Primary Outcome Measures

Prenatal Comfort Scale
The minimum score that can be obtained from the scale is "0", the maximum score is "75", and as the score obtained from the scale increases, prenatal comfort levels also increase.
Fetal Health Anxiety Inventory
The minimum score that can be obtained from the scale is "0", the maximum score is "42", and as the score obtained from the scale increases, fetal health anxiety levels also increase.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2022
Last Updated
February 23, 2023
Sponsor
Amasya University
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1. Study Identification

Unique Protocol Identification Number
NCT05441124
Brief Title
The Effect of Web-based Mindfulness-based Stress Reduction Program on Pregnant Women
Official Title
The Effect of Web-based Mindfulness-Based Stress Reduction Program on Prenatal Comfort and Fetal Anxiety Levels in Pregnants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
November 1, 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 period in which physiological and psychological changes are experienced and discomforts related to these changes are observed, and comfort is affected for the pregnant. However, fetal health concern refers to the concern of the expectant mother about the health of her developing fetus. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.
Detailed Description
Women experience intense physiological, psychological and social changes during pregnancy and postpartum period. Pregnancy and postpartum period can be a difficult process for some women due to biological and environmental factors. Mindfulness-based approaches have been used in solving both physical and mental problems in pregnant women and very positive results have been obtained. The aim of this study, which is carried out to determine the effect of mindfulness on prenatal comfort and fetal anxiety levels in pregnant women, is aimed at creating intervention programs compatible with the antenatal period and contributing to the improvement of pregnancy outcomes. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (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
Control
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Mindfullness Based Stress Reduction (MBSR) intervention
Intervention Description
Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program
Primary Outcome Measure Information:
Title
Prenatal Comfort Scale
Description
The minimum score that can be obtained from the scale is "0", the maximum score is "75", and as the score obtained from the scale increases, prenatal comfort levels also increase.
Time Frame
At the end of the 2 months
Title
Fetal Health Anxiety Inventory
Description
The minimum score that can be obtained from the scale is "0", the maximum score is "42", and as the score obtained from the scale increases, fetal health anxiety levels also increase.
Time Frame
At the end of the 2 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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Not having any diagnosed psychiatric disease, Literate, Using a smart phone, With internet access Having a headset accessory for phone calls, Pregnant women who voluntarily agreed to participate in the study Exclusion Criteria: Filling in the questionnaire form incompletely, Pregnant women with communication barriers and 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 Web-based Mindfulness-based Stress Reduction Program on Pregnant Women

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