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

NCT05317065 | Completed

• 1 other identifier: Amasya Univesity
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress; Pregnancy, High Risk

Keywords

prenatal attachment; Anxiety

Outcome Measures

Primary Outcomes (2)

• Prenatal Distress Scale

  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.

  At the end of the 1 months

• Pregnancy-Related Anxiety Scale

  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.

  At the end of the 1 months

Secondary Outcomes (1)

• The Prenatal Attachment Inventory

  At the end of the 1 months

Study Arms (2)

Mindfullness Based Stress Reduction

EXPERIMENTAL

Mindfullness Based Stress Reduction (MBSR) therapy

Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention

Control

NO INTERVENTION

Control

Interventions

Mindfullness Based Stress Reduction (MBSR) intervention BEHAVIORAL

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

Mindfullness Based Stress Reduction

Eligibility Criteria

• Age: 15 Years - 40 Years
• Gender Eligibility Details: Pregnant
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• risky pregnant women

You may not qualify if:

• mental disabilities

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Amasya University

Amasya, 05000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher of the Amasya University Midwifery Department

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: June 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 31, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)