NCT05495022

Brief Summary

Mindfulness; It is the state of paying attention and being aware of what is happening right now. Mindfulness, includes noticing what is happening in the present moment and the way of meeting all that is noticed. The research will be conducted in a randomized controlled manner in order to determine the Effect of MBSR (Conscious Awareness Based Stress Reduction) Program on Anxiety, Work Related Emotional Burnout and Job Satisfaction in midwives. Data will be collected from midwives working at Gaziantep Cengiz Gökçek Gynecology and Childhood Hospital between September 1 and December 30, 2022. Midwives who agree to participate in the study and meet the criteria will be sent and asked to fill in web-based online questionnaires (Whatsapp) prepared by the researchers through Google Forms. As a pre-test, "Descriptive Information Form", "Beck Anxiety Scale (BAI)", "Work-Related Emotional Burnout Scale" and "Minnesota Job Satisfaction Scale (MSQ) Short Form" will be administered to midwives in the experimental and control groups. After the stress reduction program based on mindfulness was applied online by the researcher to the experimental group, 2 sessions a week for 4 weeks (1 month), a total of 8 sessions; Post-test data will be obtained by re-applying the "Beck Anxiety Scale (BAS)", "Work-Related Emotional Burnout Scale" and "Minnesota Job Satisfaction Scale (MSQ) Short Form" scale to the experimental group and simultaneously to the control group. The universe of the research will be composed of midwives working at Gaziantep Cengiz Gökçek Gynecology and Childhood Hospital on the relevant dates. The minimum number of individuals to be included in the sample of the study was determined by power analysis. Sample size when power analysis is done; Assuming that the method applied with 5% error level, bidirectional significance level, 95% confidence interval and 80% ability to represent the universe, would reduce the anxiety score averages (8.20±8.64) by 6 points, a total of 66 midwives (33 experimental, 33 control) calculated. A total of 80 midwives (40 experimental, 40 control) are planned to be included in the study, taking into account possible case losses (approximately 20%).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2022

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

27 days

First QC Date

August 8, 2022

Last Update Submit

August 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Beck Anxiety Scale

    It is a 4-point Likert type scale, developed by Beck et al.(1988) and validated in Turkish by Ulusoy et al.(1998), and consists of 21 questions aiming to measure the severity of anxiety. The items of the scale are scored between 0-3 and a high total score indicates an increased level of anxiety and a low score between 8-15 points; A score of 16-25 indicates moderate anxiety, and a score of 26-63 indicates a high level of anxiety.

    Change in anxiety at 4 weeks

Secondary Outcomes (2)

  • Work-Related Emotional Burnout Scale

    Change in work-related emotional burnout at 4 weeks

  • Minnesota Job Satisfaction Scale (MSQ) Short Form

    Change in job satisfaction in 4 weeks

Study Arms (2)

MBSR group

EXPERIMENTAL

Mindfulness-based stress reduction (MBSR) program

Behavioral: Mindfulness-based stress reduction (MBSR) program

Control group

NO INTERVENTION

standard care group

Interventions

Mindfulness-based stress reduction (MBSR) program will be applied by the researcher to the midwives in the experimental group. Conscious Awareness-Based Stress Reduction will be applied by the researcher (S.Ö.C.) who has received training (16 hours) and has a certificate in this field. Stress reduction program based on mindfulness is planned as 2 sessions per week for 4 weeks, a total of 8 sessions. Each session is planned to last 40-60 minutes on average. Sessions will continue as individual and group sessions by determining the days when midwives are available online.

MBSR group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a midwifery graduate (High school, undergraduate) Working actively at Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital Volunteering to participate in the study be over 18 years old

You may not qualify if:

  • Not wanting to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Science

Gaziantep, Şahinbey/ Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (3)

  • Mayer B, Polak MG, Remmerswaal D. Mindfulness, Interpretation Bias, and Levels of Anxiety and Depression: Two Mediation Studies. Mindfulness (N Y). 2019;10(1):55-65. doi: 10.1007/s12671-018-0946-8. Epub 2018 Apr 12.

    PMID: 30662572BACKGROUND
  • Lin L, He G, Yan J, Gu C, Xie J. The Effects of a Modified Mindfulness-Based Stress Reduction Program for Nurses: A Randomized Controlled Trial. Workplace Health Saf. 2019 Mar;67(3):111-122. doi: 10.1177/2165079918801633. Epub 2018 Oct 29.

    PMID: 30370837BACKGROUND
  • Kriakous SA, Elliott KA, Lamers C, Owen R. The Effectiveness of Mindfulness-Based Stress Reduction on the Psychological Functioning of Healthcare Professionals: a Systematic Review. Mindfulness (N Y). 2021;12(1):1-28. doi: 10.1007/s12671-020-01500-9. Epub 2020 Sep 24.

MeSH Terms

Conditions

Anxiety DisordersBurnout, Professional

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental DisordersOccupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
: Principal Investigator

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

June 4, 2022

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations