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

Anxiety Clinical Trial

Official title:

The Effect of Web-based Mindfulness-Based Stress Reduction Program on Prenatal Comfort and Fetal Anxiety Levels in Pregnants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05441124
• Other study ID #: Amasya Uni
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: November 1, 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pregnancy Related

Intervention

Behavioral:
• Mindfullness Based Stress Reduction (MBSR) intervention
Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program

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	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.	At the end of the 2 months
Primary	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.	At the end of the 2 months