MindfulnessNCT05507307
The Effect of Mindfulness-Based Pregnancy Education Program on Stress, Birth Fear and Birth Self-Efficacy in Pregnants
A study testing mindfulness-based pregnancy education program. in people with Mindfulness and Pregnancy, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The research will be carried out to determine the effect of mindfulness-based pregnancy education program on stress, fear of childbirth and birth self-efficacy in pregnant women. The study was designed as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Pregnancy, Stress
- What is being tested?
- mindfulness-based pregnancy education program.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2022to 30 Dec 2023
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not having any diagnosed psychiatric disease,
- Able to read and write,
- Using a smart phone,
- with internet access
- Having a headset accessory for phone calls,
- Pregnant women who voluntarily agreed to participate in the study
Who cannot join
- Pregnant women with communication barriers and mental disabilities
- Pregnant women under the age of 18
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Science
Gaziantep, Şahinbey/ Gaziantep, 27010
About this study
The research will be carried out to determine the effect of mindfulness-based pregnancy education program on stress, fear of childbirth and birth self-efficacy in pregnant women. The study was designed as a randomized controlled trial. The universe of the research will consist of pregnant women who applied to Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital Pregnancy training class. The sample of the research, on the other hand, was determined by power analysis, at least the number of individuals to be included in the sample of the research. 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 (30.53±6.49) by 4 points, a total of 84 pregnant women (42 experimental, 42 control) were calculated. Introductory Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Birth Attitude Scale" and "Birth Self-Efficacy Scale short form" will be used.
It is predicted that the research will contribute to the literature in line with its originality and results.
Read the detailed description
The research will be carried out to determine the effect of mindfulness-based pregnancy education program on stress, fear of childbirth and birth self-efficacy in pregnant women. The study was designed as a randomized controlled trial. The universe of the research will consist of pregnant women who applied to Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital Pregnancy training class. The sample of the research, on the other hand, was determined by power analysis, at least the number of individuals to be included in the sample of the research. 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 (30.53±6.49) by 4 points, a total of 84 pregnant women (42 experimental, 42 control) were calculated. Introductory Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Birth Attitude Scale" and "Birth Self-Efficacy Scale short form" will be used.
Pregnant Information Form: It is a form consisting of 21 questions developed by the researchers in line with the literature in order to determine the socio-demographic, obstetric and health characteristics of women.
Prenatal Distress Scale (PBL)- Revised Version The "Prenatal Distress Scale" was developed by Yali and Lobel in 1999 to assess women's social relations, physical and emotional symptoms, and concerns about themselves and their baby during pregnancy (14). The first 12-item scale was developed by Lobel in 2008 and a 17-item Prenatal Distress - Revised version was created (15). The Turkish validity and reliability study was performed by Yüksel et al. in 2011 (16). In the internal consistency analysis of the scale (n=522), the Cronbach's alpha internal consistency coefficient was 0.85, and the item 36 total score correlation coefficients (r) ranged from 0.20 to 0.78 (p<0.001). The scale is in 3-point Likert type. The participants are asked to read the statement in the scale and choose the one that suits them from the sequential statements "Not at all" (0), "A little" (1) and "Too much" (2). The minimum score that can be obtained from the scale is "0" and the maximum score is "34", and as the score obtained from the scale increases, prenatal distress levels also increase. The scale has no breakpoints.
Birth Attitude Scale Birth attitude scale is a scale developed by Lowe to measure fear of birth. This scale is a four-point Likert scale consisting of 16 items, with a high score indicating high anxiety. 1= No worries; no fear, 2= Low anxiety; not enough to be called fear, 3= moderate anxiety; distressing but enough to affect feelings of well-being 4 = high anxiety; It is evaluated as very worrying and affecting the sense of well-being. The Cronbach alpha coefficient of the scale, which was performed by Dönmez et al. in 2012, was found to be 0.82.
Birth Self-Efficacy Scale Short form The Birth Self-Efficacy Scale, consisting of 28 items, has two sub-dimensions as result expectation and self-efficacy expectation, scored from 1 to 10, 1 = 'I'm NOT SURE' 10 = 'TOTALLY SURE'. The lowest score that can be obtained from the scale is 28, the lowest The high score is 280, and it is accepted that as the score increases, birth self-efficacy increases, and as the score decreases, it decreases. Its Turkish validity and reliability were evaluated in 2021 by Aydın et al. The Cronbach alpha coefficient of the scale was found to be 0.82.
Data Collection: The data will be interviewed and invited by the researchers to the pregnant women who applied to the pregnant training class at Gaziantep Cengiz Gökçek Gynecology and Childhood Hospital between July 2022 and December 2022. Pregnant women who accept to participate in the study and meet the criteria will be filled by the researchers by face-to-face interview method. As a pre-test, "Descriptive Information Form", "Prenatal Distress Scale (PBL) - Revised Version", "Birth attitude scale" and "birth self-efficacy scale - short form" will be applied to the pregnants in the experimental and control groups. After the conscious awareness-based pregnancy education program was applied to the experimental group, 2 sessions a week for 4 weeks (1 month), a total of 8 sessions, the "Prenatal Distress Scale (PBL) - Revised Version", "Birth Attitude Scale" was applied to the experimental group and simultaneously to the control group. and 'birth self-efficacy scale-short form' will be applied. They will receive the pregnant training given in the routine pregnant class.
It is predicted that the research will contribute to the literature in line with its originality and results.
- Conditions
- Mindfulness, Pregnancy, Stress, Childbirth, Midwife
- Being tested
- mindfulness-based pregnancy education program.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based pregnancy education program.Behavioural
Pregnant education program based on mindfulness is planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session is planned to last 40-60 minutes on average. Sessions will continue as individu
| Study group | Role | What they receive |
|---|---|---|
| MBSR group | Experimental | mindfulness-based pregnancy education program group Receives: Behavioral: mindfulness-based pregnancy education program. |
| Control group | No intervention | control group standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Distress Scale (PBL)- Revised Version
The "Prenatal Distress Scale" was developed by Yali and Lobel in 1999 to assess women's social relations, physical and emotional symptoms, and concerns about themselves and their baby during pregnancy (14). The first 12-item scale was developed by Lobel in 2008 and a 17-item Prenatal Distress - Revised version was created (15). The Turkish validity and reliability study was performed by Yüksel et al. in 2011 (16). In the internal consistency analysis of the scale (n=522), Cronbach's alpha internal consistency coefficient was 0.85, and item 36 total score correlation coefficients (r) ranged from 0.20 to 0.78 (p<0.001). The scale is 3-point Likert type.
Measured: Change in stress at 4 weeks
Secondary outcomes (1)
Birth Attitude Scale
The birth attitude scale is a scale developed by Lowe to measure the fear of birth. This scale is a four-point Likert scale consisting of 16 items, with a high score indicating high anxiety. 1= No worries; no fear, 2= Low anxiety; not enough to be called fear, 3= moderate anxiety; distressing but enough to affect feelings of well-being 4 = high anxiety; It is evaluated as very worrying and affecting the sense of well-being. The Cronbach alpha coefficient of the scale, which was performed by Dönmez et al. in 2012, was found to be 0.82.
Measured: Change in Birth Attitude within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start17 Aug 2022
- Primary completion1 Oct 2023
- Study completion30 Dec 2023
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 MindfulnessStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıdıka Özlem CENGİZHAN, Inonu University
- Investigators
- Sıdıka Özlem CENGİZHAN, Assistant Professor, Principal investigator, Gaziantep Islamic Science and Technology University faculty of health sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507307
- Sponsor's protocol ID
- 117.17.06
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth. J Midwifery Womens Health. 2014 Mar-Apr;59(2):192-7. doi: 10.1111/jmwh.12075. Epub 2013 Dec 10.
PubMed 24325752Zemestani M, Fazeli Nikoo Z. Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. Arch Womens Ment Health. 2020 Apr;23(2):207-214. doi: 10.1007/s00737-019-00962-8. Epub 2019 Apr 13.
PubMed 30982086Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y.
PubMed 26518597
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Pregnancy Education Program on Stress, Birth Fear and Birth Self-Efficacy in Pregnants
- ClinicalTrials.gov ID
- NCT05507307
- Acronym / sponsor ID
- 117.17.06
- Conditions
- Mindfulness, Pregnancy, Stress, Childbirth, Midwife
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 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.
The research will be carried out to determine the effect of mindfulness-based pregnancy education program on stress, fear of childbirth and birth self-efficacy in pregnant women. The study was designed as a randomized controlled trial. The universe of the research will consist of pregnant women who applied to Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital Pregnancy training class. The sample of the research, on the other hand, was determined by power analysis, at least the number of individuals to be included in the sample of the research. 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 (30.53±6.49) by 4 points, a total of 84 pregnant women (42 experimental, 42 control) were calculated. Introductory Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Birth Attitude Scale" and "Birth Self-Efficacy Scale short form" will be used.
It is predicted that the research will contribute to the literature in line with its originality and results.
Detailed description
The research will be carried out to determine the effect of mindfulness-based pregnancy education program on stress, fear of childbirth and birth self-efficacy in pregnant women. The study was designed as a randomized controlled trial. The universe of the research will consist of pregnant women who applied to Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital Pregnancy training class. The sample of the research, on the other hand, was determined by power analysis, at least the number of individuals to be included in the sample of the research. 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 (30.53±6.49) by 4 points, a total of 84 pregnant women (42 experimental, 42 control) were calculated. Introductory Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Birth Attitude Scale" and "Birth Self-Efficacy Scale short form" will be used.
Pregnant Information Form: It is a form consisting of 21 questions developed by the researchers in line with the literature in order to determine the socio-demographic, obstetric and health characteristics of women.
Prenatal Distress Scale (PBL)- Revised Version The "Prenatal Distress Scale" was developed by Yali and Lobel in 1999 to assess women's social relations, physical and emotional symptoms, and concerns about themselves and their baby during pregnancy (14). The first 12-item scale was developed by Lobel in 2008 and a 17-item Prenatal Distress - Revised version was created (15). The Turkish validity and reliability study was performed by Yüksel et al. in 2011 (16). In the internal consistency analysis of the scale (n=522), the Cronbach's alpha internal consistency coefficient was 0.85, and the item 36 total score correlation coefficients (r) ranged from 0.20 to 0.78 (p<0.001). The scale is in 3-point Likert type. The participants are asked to read the statement in the scale and choose the one that suits them from the sequential statements "Not at all" (0), "A little" (1) and "Too much" (2). The minimum score that can be obtained from the scale is "0" and the maximum score is "34", and as the score obtained from the scale increases, prenatal distress levels also increase. The scale has no breakpoints.
Birth Attitude Scale Birth attitude scale is a scale developed by Lowe to measure fear of birth. This scale is a four-point Likert scale consisting of 16 items, with a high score indicating high anxiety. 1= No worries; no fear, 2= Low anxiety; not enough to be called fear, 3= moderate anxiety; distressing but enough to affect feelings of well-being 4 = high anxiety; It is evaluated as very worrying and affecting the sense of well-being. The Cronbach alpha coefficient of the scale, which was performed by Dönmez et al. in 2012, was found to be 0.82.
Birth Self-Efficacy Scale Short form The Birth Self-Efficacy Scale, consisting of 28 items, has two sub-dimensions as result expectation and self-efficacy expectation, scored from 1 to 10, 1 = 'I'm NOT SURE' 10 = 'TOTALLY SURE'. The lowest score that can be obtained from the scale is 28, the lowest The high score is 280, and it is accepted that as the score increases, birth self-efficacy increases, and as the score decreases, it decreases. Its Turkish validity and reliability were evaluated in 2021 by Aydın et al. The Cronbach alpha coefficient of the scale was found to be 0.82.
Data Collection: The data will be interviewed and invited by the researchers to the pregnant women who applied to the pregnant training class at Gaziantep Cengiz Gökçek Gynecology and Childhood Hospital between July 2022 and December 2022. Pregnant women who accept to participate in the study and meet the criteria will be filled by the researchers by face-to-face interview method. As a pre-test, "Descriptive Information Form", "Prenatal Distress Scale (PBL) - Revised Version", "Birth attitude scale" and "birth self-efficacy scale - short form" will be applied to the pregnants in the experimental and control groups. After the conscious awareness-based pregnancy education program was applied to the experimental group, 2 sessions a week for 4 weeks (1 month), a total of 8 sessions, the "Prenatal Distress Scale (PBL) - Revised Version", "Birth Attitude Scale" was applied to the experimental group and simultaneously to the control group. and 'birth self-efficacy scale-short form' will be applied. They will receive the pregnant training given in the routine pregnant class.
It is predicted that the research will contribute to the literature in line with its originality and results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| MBSR group | Experimental | Behavioral: mindfulness-based pregnancy education program.mindfulness-based pregnancy education program group |
| Control group | No intervention | –control group standard care group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Not having any diagnosed psychiatric disease,
Key exclusion criteria (2 listed)
- Pregnant women with communication barriers and mental disabilities
- Pregnant women under the age of 18
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 pregnancy education program.Pregnant education program based on mindfulness is planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session is planned to last 40-60 minutes on average. Sessions will continue as individu | Behavioural | MBSR group |
Primary outcome
Prenatal Distress Scale (PBL)- Revised Version
Time frame: Change in stress at 4 weeks
The "Prenatal Distress Scale" was developed by Yali and Lobel in 1999 to assess women's social relations, physical and emotional symptoms, and concerns about themselves and their baby during pregnancy (14). The first 12-item scale was developed by Lobel in 2008 and a 17-item Prenatal Distress - Revised version was created (15). The Turkish validity and reliability study was performed by Yüksel et al. in 2011 (16). In the internal consistency analysis of the scale (n=522), Cronbach's alpha internal consistency coefficient was 0.85, and item 36 total score correlation coefficients (r) ranged from 0.20 to 0.78 (p<0.001). The scale is 3-point Likert type.
1 secondary outcome
Birth Attitude Scale
Time frame: Change in Birth Attitude within 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 13 Feb 2024.
- Background: PubMed 24325752Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth. J Midwifery Womens Health. 2014 Mar-Apr;59(2):192-7. doi: 10.1111/jmwh.12075. Epub 2013 Dec 10.
- Background: PubMed 30982086Zemestani M, Fazeli Nikoo Z. Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. Arch Womens Ment Health. 2020 Apr;23(2):207-214. doi: 10.1007/s00737-019-00962-8. Epub 2019 Apr 13.
- Background: PubMed 26518597Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y.
- Individual participant dataSharing planned: No
Related trials for Mindfulness
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruiting
Physiology of Liberation
Psychophysiological Reactivity and Recovery
RecruitingPhase 2
Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement
Opioid Use Disorder
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.
Sıdıka Özlem CENGİZHAN, Assistant Professor principal investigator
Gaziantep Islamic Science and Technology University faculty of health sciences
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 pregnancy education program. in people with Mindfulness and Pregnancy, 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 6 inclusion and 2 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 13 Feb 2024. 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?
Prenatal Distress Scale (PBL)- Revised Version (time frame: Change in stress 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 NCT05507307, 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 13 Feb 2024.