Fear of ChildbirthNCT04833842
Childbirth Preparation Program Developed Based on Health Belief Model
A study testing Web-based childbirth preparation program developed based on health belief model and supported by motivational interview and Web-based childbirth preparation program based on health belief model in people with Fear of Childbirth and Self-efficacy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Pregnants who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, had a higher perception of birth self-efficacy than those who did not pass. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Self-efficacy
- What is being tested?
- Web-based childbirth preparation program developed based on health belief model and supported by motivational interview and Web-based childbirth preparation program based on health belief model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 30 Jul 2021
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35,
- At least a primary school graduate,
- According to the last menstrual period or the results of ultrasonography of pregnant women who do not know the last menstrual period, who are in the 28-30 weeks of pregnancy,
- Primigravida,
- Live single pregnancy,
- Without any obstacle to give birth through normal vaginal way,
Show all 14Show fewer
- No specified cesarean indication or risk factors that would adversely affect normal delivery (Heart disease, placenta previa, oligohydramnios, preeclampsia, anhydramnios, diabetes, epilepsy),
- Not pregnant as a result of infertility treatment,
- The state anxiety scale average score is below 60,
- Edinburgh Postpartum Depression Scale average score of 12 or below,
- Residing within the provincial borders of Sivas,
- Internet at home,
- Able to use a computer or mobile phone,
- They are pregnant women who agree to participate in the research.
Who cannot join
- Participants in the birth preparation class
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-Birth Program Developed Based on Health Belief Model on Fear of Birth, Birth Self-Efficacy, Birth Process and Perception in Primigravida Pregnant Women
Pregnants who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, had a higher perception of birth self-efficacy than those who did not pass.
Pregnant women who underwent a web-based preparation for labor program, which was developed based on a health belief model and supported by motivational interviews, had a more positive perception of birth than those who did not pass.
Read more
The level of fear experienced at birth is lower in pregnant women who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews.
The frequency of voluntary cesarean delivery is lower in pregnant women who undergo a web-based preparation for labor program, which is developed based on the health belief model and supported by motivational interviews.
The frequency of episiotomy is lower in pregnant women who undergo a web-based preparation for labor program, which is developed based on a health belief model and supported by motivational interviews.
Induction frequency is lower in pregnant women who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, than those who did not pass.
Pregnants who underwent a web-based preparation program for labor, which was developed based on the health belief model and supported by motivational interviews, had a shorter delivery period than those who did not pass.
Read the detailed description
In the three-month study, a web-based childbirth preparation program will be applied to primigravida women in the initiative group, based on the Health Belief Model and supported by motivational interviews. Training will take five weeks. Beginning from the 30th week of pregnancy, pregnant women will be asked to read the first part of the website and a suitable time will be determined for a motivational interview by calling the phone within that week. All applications of pregnant women related to the website will be evaluated. At the specified time, pregnant women will be taken to motivational interview training based on the Health Belief Model and the trainings will be carried out individually and online. A web-based birth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Training will take five weeks. Beginning from the 30th week of pregnancy, pregnant women will be asked to read the first part of the website. All applications of pregnant women related to the website will be evaluated.
- Conditions
- Fear of Childbirth, Self-efficacy
- Being tested
- Web-based childbirth preparation program developed based on health belief model and supported by motivational interview, Web-based childbirth preparation program based on health belief model
- Keywords
- motivational interviewing, childbirth training, fear of childbirth,, self-efficacy, primigravida women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based childbirth preparation program developed based on health belief model and supported by motivational interviewOther
In the three-month study, primigravida women in the initiative group will be given a web-based childbirth preparation program, which is prepared based on the Health Belief Model and supported by motivational interviews. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth.
Web-based childbirth preparation program based on health belief modelOther
In the three-month study, a web-based childbirth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth.
| Study group | Role | What they receive |
|---|---|---|
| Web-based birth preparation program supported by motivational interview | Experimental | A web-based childbirth preparation program prepared based on the Health Belief Model and supported by motivational interviews will be applied to primigravida women in the initiative group. Receives: Other: Web-based childbirth preparation program developed based on health belief model and supported by motivational interview |
| web-based birth preparation program | Experimental | A web-based birth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Receives: Other: Web-based childbirth preparation program based on health belief model |
What is being measured
The primary outcome is the main question the study is designed to answer.
has an effect on the fear of childbirth fear of birth birth self-efficacy
Wijma Birth Expectation / Experience Scale Version A: It is a scale consisting of 33 items. The answers in the scale are numbered from 0 to 5, and are in six-point Likert type. Zero is expressed as "completely" and 5 as "nothing". While the minimum score on the scale is 0, the maximum score is 165. A high item total score indicates a high level of fear. Eighty-five and above points indicate clinical level fear.
Measured: 3 months
has an impact on birth self-efficacy
Short Version of the Self-Efficacy Scale in Labor: Each sub-dimension of the scale consists of two sub-dimensions, and consists of 16 questions. The lowest score to be obtained from the scale sub-dimensions is 16 and the highest score is 160. The lowest total score that can be obtained from the scale is 32, and the total highest score is 320. High scores to be obtained from the scale indicate that pregnant women have high levels of self-efficacy in labor.
Measured: 3 months
has an effect on birth health belief
Birth Health Belief Scale: The scale consists of 34 items and has five sub-dimensions. According to the subscales of the scale, the average "self-efficacy and motivation perception" is high 3.810 ± 1.409 (Min = 1; Max = 5), the average "benefit and motivation perception" is very high 4.368 ± 0.909 (Min = 1.75; Max = 5), "sensitivity perception of perception high 3,500 ± 1,502 (Min = 1; Max = 5), "caring / seriousness perception" average high 3,441 ± 1,600 (Min = 1; Max = 5), average "obstacle perception" 3,071 ± 1,508 (Min = 1; Max = 5).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start15 Apr 2021 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bi̇rnur Yeşi̇ldağ Çeli̇k, Cumhuriyet University
- Investigators
- BİRNUR YEŞİLDAĞ ÇELİK, Lecturer, Principal investigator, SİVAS CUMHURİYET UNIVERSITYZEHRA GÖLBAŞI, Prof. Dr, Study director, LOKMAN HEKİM UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833842
- Sponsor's protocol ID
- SİVAS CUMHURİYET ÜNİVERSİTESİ
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected will share
Publications
Artieta-Pinedo I, Paz-Pascual C, Grandes G, Remiro-Fernandezdegamboa G, Odriozola-Hermosilla I, Bacigalupe A, Payo J. The benefits of antenatal education for the childbirth process in Spain. Nurs Res. 2010 May-Jun;59(3):194-202. doi: 10.1097/NNR.0b013e3181dbbb4e.
PubMed 20421842Munkhondya BMJ, Munkhondya TE, Chirwa E, Wang H. Efficacy of companion-integrated childbirth preparation for childbirth fear, self-efficacy, and maternal support in primigravid women in Malawi. BMC Pregnancy Childbirth. 2020 Jan 21;20(1):48. doi: 10.1186/s12884-019-2717-5.
PubMed 31964346Byrne 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 24325752Toohill J, Fenwick J, Gamble J, Creedy DK, Buist A, Turkstra E, Ryding EL. A randomized controlled trial of a psycho-education intervention by midwives in reducing childbirth fear in pregnant women. Birth. 2014 Dec;41(4):384-94. doi: 10.1111/birt.12136. Epub 2014 Oct 9.
PubMed 25303111
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-Birth Program Developed Based on Health Belief Model on Fear of Birth, Birth Self-Efficacy, Birth Process and Perception in Primigravida Pregnant Women
- ClinicalTrials.gov ID
- NCT04833842
- Acronym / sponsor ID
- SİVAS CUMHURİYET ÜNİVERSİTESİ
- Conditions
- Fear of Childbirth, Self-efficacy
- Keywords
- motivational interviewing, childbirth training, fear of childbirth,, self-efficacy, primigravida women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 6 Apr 2021 (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.
Pregnants who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, had a higher perception of birth self-efficacy than those who did not pass.
Pregnant women who underwent a web-based preparation for labor program, which was developed based on a health belief model and supported by motivational interviews, had a more positive perception of birth than those who did not pass.
The level of fear experienced at birth is lower in pregnant women who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews.
The frequency of voluntary cesarean delivery is lower in pregnant women who undergo a web-based preparation for labor program, which is developed based on the health belief model and supported by motivational interviews.
The frequency of episiotomy is lower in pregnant women who undergo a web-based preparation for labor program, which is developed based on a health belief model and supported by motivational interviews.
Induction frequency is lower in pregnant women who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, than those who did not pass.
Pregnants who underwent a web-based preparation program for labor, which was developed based on the health belief model and supported by motivational interviews, had a shorter delivery period than those who did not pass.
Detailed description
In the three-month study, a web-based childbirth preparation program will be applied to primigravida women in the initiative group, based on the Health Belief Model and supported by motivational interviews. Training will take five weeks. Beginning from the 30th week of pregnancy, pregnant women will be asked to read the first part of the website and a suitable time will be determined for a motivational interview by calling the phone within that week. All applications of pregnant women related to the website will be evaluated. At the specified time, pregnant women will be taken to motivational interview training based on the Health Belief Model and the trainings will be carried out individually and online. A web-based birth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Training will take five weeks. Beginning from the 30th week of pregnancy, pregnant women will be asked to read the first part of the website. All applications of pregnant women related to the website will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Web-based birth preparation program supported by motivational interview | Experimental | Other: Web-based childbirth preparation program developed based on health belief model and supported by motivational interviewA web-based childbirth preparation program prepared based on the Health Belief Model and supported by motivational interviews will be applied to primigravida women in the initiative group. |
| web-based birth preparation program | Experimental | Other: Web-based childbirth preparation program based on health belief modelA web-based birth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Between the ages of 18-35,
- At least a primary school graduate,
- According to the last menstrual period or the results of ultrasonography of pregnant women who do not know the last menstrual period, who are in the 28-30 weeks of pregnancy,
- Primigravida,
- Live single pregnancy,
Key exclusion criteria (1 listed)
- Participants in the birth preparation class
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 |
|---|---|---|
| Web-based childbirth preparation program developed based on health belief model and supported by motivational interviewIn the three-month study, primigravida women in the initiative group will be given a web-based childbirth preparation program, which is prepared based on the Health Belief Model and supported by motivational interviews. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth. | Other | Web-based birth preparation program supported by motivational interview |
| Web-based childbirth preparation program based on health belief modelIn the three-month study, a web-based childbirth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth. | Other | web-based birth preparation program |
Primary outcome
has an effect on the fear of childbirth fear of birth birth self-efficacy
Time frame: 3 months
Wijma Birth Expectation / Experience Scale Version A: It is a scale consisting of 33 items. The answers in the scale are numbered from 0 to 5, and are in six-point Likert type. Zero is expressed as "completely" and 5 as "nothing". While the minimum score on the scale is 0, the maximum score is 165. A high item total score indicates a high level of fear. Eighty-five and above points indicate clinical level fear.
has an impact on birth self-efficacy
Time frame: 3 months
Short Version of the Self-Efficacy Scale in Labor: Each sub-dimension of the scale consists of two sub-dimensions, and consists of 16 questions. The lowest score to be obtained from the scale sub-dimensions is 16 and the highest score is 160. The lowest total score that can be obtained from the scale is 32, and the total highest score is 320. High scores to be obtained from the scale indicate that pregnant women have high levels of self-efficacy in labor.
has an effect on birth health belief
Time frame: 3 months
Birth Health Belief Scale: The scale consists of 34 items and has five sub-dimensions. According to the subscales of the scale, the average "self-efficacy and motivation perception" is high 3.810 ± 1.409 (Min = 1; Max = 5), the average "benefit and motivation perception" is very high 4.368 ± 0.909 (Min = 1.75; Max = 5), "sensitivity perception of perception high 3,500 ± 1,502 (Min = 1; Max = 5), "caring / seriousness perception" average high 3,441 ± 1,600 (Min = 1; Max = 5), average "obstacle perception" 3,071 ± 1,508 (Min = 1; Max = 5).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Background: PubMed 20421842Artieta-Pinedo I, Paz-Pascual C, Grandes G, Remiro-Fernandezdegamboa G, Odriozola-Hermosilla I, Bacigalupe A, Payo J. The benefits of antenatal education for the childbirth process in Spain. Nurs Res. 2010 May-Jun;59(3):194-202. doi: 10.1097/NNR.0b013e3181dbbb4e.
- Background: PubMed 31964346Munkhondya BMJ, Munkhondya TE, Chirwa E, Wang H. Efficacy of companion-integrated childbirth preparation for childbirth fear, self-efficacy, and maternal support in primigravid women in Malawi. BMC Pregnancy Childbirth. 2020 Jan 21;20(1):48. doi: 10.1186/s12884-019-2717-5.
- 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 25303111Toohill J, Fenwick J, Gamble J, Creedy DK, Buist A, Turkstra E, Ryding EL. A randomized controlled trial of a psycho-education intervention by midwives in reducing childbirth fear in pregnant women. Birth. 2014 Dec;41(4):384-94. doi: 10.1111/birt.12136. Epub 2014 Oct 9.
- Individual participant dataSharing planned: Yes. All IPD collected will share
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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.
BİRNUR YEŞİLDAĞ ÇELİK, Lecturer principal investigator
SİVAS CUMHURİYET UNIVERSITY
ZEHRA GÖLBAŞI, Prof. Dr study director
LOKMAN HEKİM UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based childbirth preparation program developed based on health belief model and supported by motivational interview and Web-based childbirth preparation program based on health belief model in people with Fear of Childbirth and Self-efficacy, run by Cumhuriyet 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 14 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BİRNUR YEŞİLDAĞ ÇELİK, Lecturer (05336815923, nurumbirnur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
has an effect on the fear of childbirth fear of birth birth self-efficacy (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT04833842, which also lists 4 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 6 Apr 2021.