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Completed

NCT Number: NCT05317065

The Effect of Mindfulness-Based Stress Reduction Program (MBSR) in Risky Pregnants

Risky pregnant women need various physical and mental health needs, they need to be informed and supported by health personnel. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". 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

Stress Anxiety Disorders Mental Disorders Pregnancy, High Risk

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

Risky pregnancies are a situation that can negatively affect the health of the mother and the fetus, result in the loss of the baby, and bring about physical, social and mental changes. 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 was carried out to determine the effect of mindfulness-based stress reduction program (MBSR) on stress, anxiety and prenatal attachment in high-risk pregnant women, is aimed at creating appropriate intervention programs for high-risk pregnancies and contributing to the improvement of pregnancy outcomes. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

risky pregnant women

Exclusion criteria

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 Distress Scale

    Time frame: At the end of the 1 months

    The minimum score that can be obtained from the scale is "0", the maximum score is "34", and as the score obtained from the scale increases, prenatal distress levels also increase.

  2. Pregnancy-Related Anxiety Scale

    Time frame: At the end of the 1 months

    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 outcomes

  1. The Prenatal Attachment Inventory

    Time frame: At the end of the 1 months

    A minimum of 21 and a maximum of 84 points can be obtained from the scale. The increase in the score obtained by the pregnant indicates that the level of attachment also increases.

Sponsors and collaborators

Lead sponsor

Amasya University

Other

Registry information

Official study title

The Effect of Mindfulness-Based Stress Reduction Program (MBSR) on Stress, Anxiety and Prenatal Attachment in Risky Pregnants

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 7, 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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