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

Sponsor

Amasya University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05317065

Collaborator

(none)

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

25.9

Patients Per Site Per Month

Study Details

Study Description

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 92 pregnant women (46 experimental, 46 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Pregnancy, High Risk	Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention	N/A

Detailed Description

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 92 pregnant women (46 experimental, 46 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfullness Based Stress Reduction Mindfullness Based Stress Reduction (MBSR) therapy	Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program
No Intervention: Control Control

Arm

Intervention/Treatment

Experimental: Mindfullness Based Stress Reduction

Mindfullness Based Stress Reduction (MBSR) therapy

Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention

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

No Intervention: Control

Control

Outcome Measures

Primary Outcome Measures

Prenatal Distress Scale [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.
Pregnancy-Related Anxiety Scale [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 Outcome Measures

The Prenatal Attachment Inventory [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

risky pregnant women

Exclusion Criteria:

mental disabilities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amasya University	Amasya		Turkey	05000

Sponsors and Collaborators

Amasya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emine Akca, Clinical Researcher of the Amasya University Midwifery Department, Amasya University

ClinicalTrials.gov Identifier:

NCT05317065

Other Study ID Numbers:

Amasya Univesity

First Posted:

Apr 7, 2022

Last Update Posted:

Apr 19, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Emine Akca, Clinical Researcher of the Amasya University Midwifery Department, Amasya University

prenatal attachment

Anxiety

Study Results

No Results Posted as of Apr 19, 2022