MidwivesNCT05495022
The Effect of MBSR (Mindfulness-Based Stress Reduction) Program on Anxiety, Work-Related Emotional Burnout and Job Satisfaction in Midwives
A study testing Mindfulness-based stress reduction (MBSR) program in people with Midwives and Mindfulness, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Midwives, Mindfulness, Anxiety
- What is being tested?
- Mindfulness-based stress reduction (MBSR) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not wanting to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Science
Gaziantep, Şahinbey/ Gaziantep, 27010
About this study
Official title: he Effect of MBSR (Conscious Awareness-Based Stress Reduction) Program on Anxiety, Work-Related Emotional Burnout and Job Satisfaction in Midwives
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.
Read more
Data will be collected from midwives working at Gaziantep Cengiz Gökçek Gynecology and Childhood Hospital between September 15 and December 15, 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.
Read the detailed description
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 15 and December 15, 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.
Data Collection Form and Tools Data will be collected with "Descriptive Information Form", "Beck Anxiety Scale (BAI)", "Work-Related Emotional Burnout Scale" and "Minnesota Job Satisfaction Scale (MSQ) Short Form".
Midwifery Initiative 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.Variables of the Study Dependent Variable: the scores of the midwives from the scales Independent Variable: Applied Mindfulness-Based Stress Reduction (MBSR) program Evaluation of Data Number, percentile distribution, arithmetic mean, chi-square test, standard deviation and Cronbach's α reliability coefficient will be used in the statistical evaluation of continuous and categorical data with SPSS 25.0 (Statistical Program in Social Sciences) program. Kolmogorov Smirnov test will be used to determine whether the data show a normal distribution. If the normal distribution is shown, the t-test will be used in dependent and independent groups; Mann Whitney-U test and Wilcoxon tests will be used in non-normally distributed groups. Significance will be accepted as p<0.05.
- Conditions
- Midwives, Mindfulness, Anxiety, Professional Burnout, Job Satisfaction
- Being tested
- Mindfulness-based stress reduction (MBSR) program
- Medical subject headings
- Anxiety Disorders, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction (MBSR) programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBSR group | Experimental | Mindfulness-based stress reduction (MBSR) program Receives: Behavioral: Mindfulness-based stress reduction (MBSR) program |
| Control group | No intervention | standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in anxiety at 4 weeks
Secondary outcomes (2)
Work-Related Emotional Burnout Scale
Turkish validity and reliability of the 6-statement and one-dimensional Work-Related Emotional Burnout Scale developed by Wharton (1993), Günay (2021). There is no reverse expression in the scale. It is designed on a 5-point Likert scale with 1 = I never feel this way, 5 = I feel this way every day. The higher the sum of statements, the higher the level of burnout.
Measured: Change in work-related emotional burnout at 4 weeks
Minnesota Job Satisfaction Scale (MSQ) Short Form
Minnesota Job Satisfaction Scale is one of the most common indices used to measure job satisfaction of employees. The scale developed by Weiss, Dawis, England, and Lofquist has two forms, the long form and short form. each item is arranged with Likert type scoring and ranging from 1 to 5; It consists of 20 items with the statements "I am not at all satisfied", "I am not satisfied", "I am undecided", "I am satisfied", "I am very satisfied". In the evaluation of the options, the highest score is 100 and the lowest score is 20. A score of 20-39 indicates very low, a score of 40-59 indicates low, a score of 60-79 indicates sufficient, and a score of 80-100 indicates high satisfaction.
Measured: Change in job satisfaction in 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start4 Jun 2022
- Primary completion1 Jul 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MidwivesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıdıka Özlem CENGİZHAN, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495022
- Sponsor's protocol ID
- 28-02-2022 / 26
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30662572Lin 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.
PubMed 30370837Kriakous 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.
PubMed 32989406
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- he Effect of MBSR (Conscious Awareness-Based Stress Reduction) Program on Anxiety, Work-Related Emotional Burnout and Job Satisfaction in Midwives
- ClinicalTrials.gov ID
- NCT05495022
- Acronym / sponsor ID
- 28-02-2022 / 26
- Conditions
- Midwives, Mindfulness, Anxiety, Professional Burnout, Job Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 15 and December 15, 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.
Detailed description
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 15 and December 15, 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.
Data Collection Form and Tools Data will be collected with "Descriptive Information Form", "Beck Anxiety Scale (BAI)", "Work-Related Emotional Burnout Scale" and "Minnesota Job Satisfaction Scale (MSQ) Short Form".
Midwifery Initiative 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.Variables of the Study Dependent Variable: the scores of the midwives from the scales Independent Variable: Applied Mindfulness-Based Stress Reduction (MBSR) program Evaluation of Data Number, percentile distribution, arithmetic mean, chi-square test, standard deviation and Cronbach's α reliability coefficient will be used in the statistical evaluation of continuous and categorical data with SPSS 25.0 (Statistical Program in Social Sciences) program. Kolmogorov Smirnov test will be used to determine whether the data show a normal distribution. If the normal distribution is shown, the t-test will be used in dependent and independent groups; Mann Whitney-U test and Wilcoxon tests will be used in non-normally distributed groups. Significance will be accepted as p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR group | Experimental | Behavioral: Mindfulness-based stress reduction (MBSR) programMindfulness-based stress reduction (MBSR) program |
| Control group | No intervention | –standard care group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not wanting to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reduction (MBSR) programMindfulness-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. | Behavioural | MBSR group |
Primary outcome
Beck Anxiety Scale
Time frame: Change in anxiety at 4 weeks
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.
2 secondary outcomes
Work-Related Emotional Burnout Scale
Time frame: Change in work-related emotional burnout at 4 weeks
Minnesota Job Satisfaction Scale (MSQ) Short Form
Time frame: Change in job satisfaction in 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 30662572Mayer 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.
- Background: PubMed 30370837Lin 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.
- Results publication: PubMed 32989406Kriakous 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction (MBSR) program in people with Midwives and Mindfulness, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Scale (time frame: Change in anxiety at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495022, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.