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

NCT ID: NCT05441124

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-11-01

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

Conditions

Anxiety; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfullness Based Stress Reduction

Mindfullness Based Stress Reduction (MBSR) therapy

Group Type: EXPERIMENTAL

Mindfullness Based Stress Reduction (MBSR) intervention

Intervention Type: BEHAVIORAL

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

Control

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfullness Based Stress Reduction (MBSR) intervention

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Amasya University

OTHER

Sponsor Role: lead

Responsible Party

Emine Akca

Assist. Prof. Dr. in the Amasya University Midwifery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amasya University

Amasya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Amasya Uni

Identifier Type: -

Identifier Source: org_study_id