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Completed

NCT Number: NCT05441124

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Pregnancy Related

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Amasya University

Amasya, 05000, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfullness Based Stress Reduction (MBSR) intervention

Behavioral

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

Primary outcomes

  1. Prenatal Comfort Scale

    Time frame: At the end of the 2 months

    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.

  2. Fetal Health Anxiety Inventory

    Time frame: At the end of the 2 months

    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.

Sponsors and collaborators

Lead sponsor

Amasya University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2022
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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