Fear of ChildbirthNCT06453811
The Effect of Spouse Participation Childbirth Preparation Program on Birth Outcomes
A study testing Self-efficacy Theory-based Childbirth Preparation Program in people with Fear of Childbirth and Childbirth Self-Efficacy, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
The research is designed as a pre-test, post-test, parallel-group, randomized controlled study to examine the effect of a spouse-participated childbirth preparation program based on self-efficacy theory on fear of childbirth, self-efficacy, mode of delivery and outcomes. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Childbirth Self-Efficacy, Mode of Delivery
- What is being tested?
- Self-efficacy Theory-based Childbirth Preparation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2025to 1 Jun 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Couples must be 18 years of age or older,
- Couples should be able to read and write Turkish,
- The pregnant woman has never given birth before,
- The pregnant woman is at 28-30 weeks of gestation,
- The pregnancy is viable and singular,
- The pregnant woman does not have an established indication for caesarean section,
- Routine controls during pregnancy are carried out in the hospital where the study is conducted.
Who cannot join
- Pregnancy achieved by assisted reproductive techniques,
- Participating in a birth preparation programme other than the routine pregnancy check-ups at the hospital,
- Failure to attend any of the sessions in the childbirth preparation programme,
- Failure to communicate in the postnatal period (no response to at least 3 telephone calls)
- Development of any indication for caesarean section during pregnancy,
- The birth takes place in a health institution different from the hospital where the research will be conducted.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim University
Ankara, Söğütözü Mahallesi, 06510
About this study
Official title: The Effect of a Self-Efficacy Theory-Based Spouse Participation Childbirth Preparation Program on Fear of Childbirth, Self-Efficacy, Mode of Delivery and Birth Outcomes: A Randomized Controlled Trial
The research is designed as a pre-test, post-test, parallel-group, randomized controlled study to examine the effect of a spouse-participated childbirth preparation program based on self-efficacy theory on fear of childbirth, self-efficacy, mode of delivery and outcomes. Participants will be allocated to experimental and control groups through block randomization. Participants in the experimental group will be enrolled in a two-session spouse-participated childbirth preparation program based on self-efficacy theory once a week, in addition to receiving routine care at the hospital. Participants in the control group will not receive any intervention, only routine care provided at the hospital.
Read the detailed description
Nulliparous pregnant women and their spouses who apply to the obstetrics and gynecology clinic and outpatient clinic of the hospital where the research will be conducted will be assessed for eligibility according to the inclusion criteria, and informed consent will be obtained. Subsequently, prospective fathers will be given a Personal Information Form and the Fathers' Fear of Childbirth Scale; prospective mothers will be given a Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A, the Childbirth Self-Efficacy Inventory Short Form, and the Perception of Spousal Support in Pregnancy Scale as pre-tests. Couples will be allocated to the experimental or control group according to a block randomization list. Couples assigned to the experimental group will be included in a three-week program, attending a self-efficacy theory-based childbirth preparation program in groups of 3-4 couples, scheduled according to their availability. At the end of the sessions, the training guide reflecting the content of the training will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue routine pregnancy controls in the hospital. Routine pregnancy check-ups at the hospital include standard antenatal follow-ups, and pregnant women and their partners receive information about the pregnancy and labour process only during the medical examination. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message contents related to the training content will be used in the reminder. After completing the training, the Fathers' Fear of Childbirth Scale, the Childbirth Self-Efficacy Inventory Short Form, and the Perception of Spousal Support in Pregnancy Scale will be administered again. Following childbirth, the Wijma Delivery Expectancy/Experience Questionnaire Version B will be completed by the mothers, and the birth process information form will be filled out by the researcher. Couples in the control group will undergo the same pre-test and post-test assessments as the experimental group. However, no additional intervention will be provided to these couples, and they will receive the same routine care as the experimental group.
- Conditions
- Fear of Childbirth, Childbirth Self-Efficacy, Mode of Delivery, Childbirth Preparation Program
- Being tested
- Self-efficacy Theory-based Childbirth Preparation Program
- Keywords
- Self-Efficacy, Childbirth Preparation, Fear of Childbirth, Mode of Delivery, Spousal Support, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-efficacy Theory-based Childbirth Preparation ProgramOther
According to the block randomisation method, the couples who are included in the experimental group by applying the pre-test will be included in the programme in groups of 3-4 couples by planning the day and time they can participate in the programme. At the end of the sessions, the training guide reflecting the training content will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue their routine pregnancy controls in the hospital. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message content related to the training content will be used in the reminder.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | According to the block randomisation method, the couples who are included in the experimental group by applying the pre-test will be included in the programme in groups of 3-4 couples by planning the day and time they can participate in the programme. At the end of the sessions, the training guide reflecting the training content will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue their routine pregnancy controls in the hospital. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message content related to the training content will be used in the reminder. Receives: Other: Self-efficacy Theory-based Childbirth Preparation Program |
| Control Group | No intervention | No additional intervention will be provided to couples in the control group, and they will receive the routine care provided at the hospital. This routine care includes standard antenatal follow-ups, during which pregnant women and their spouses receive information about pregnancy and childbirth only during physician examinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Childbirth Self-Efficacy Inventory Short Form
Measures the level of self-efficacy of expectant mothers in childbirth. The lowest score that can be obtained from the overall scale is 32 and the highest score is 320. The highest score obtained from the overall scale means that women's self-efficacy levels in childbirth are high (Ersoy \& Kukulu, 2011).
Measured: The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).
Birth Process Information Form
This form inquires about the mode of delivery and intervention at birth. One of the primary outcomes of the research is mode of delivery.
Measured: It will be applied two hours after the expectant mother gives birth.
Secondary outcomes (3)
The Fathers' Fear of Childbirth Scale
Measures the level of fear of childbirth in expectant fathers. The minimum score that can be obtained from the scale is 17 and the maximum score is 85. As the score increases, the level of fear of birth experienced by fathers also increases (Calpbinici vd., 2023).
Measured: The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).
The Wijma Delivery Expectancy/Experience Questionnaire Version A-B
Measures the level of fear of childbirth in expectant mothers. The minimum score that can be obtained from the scale is 0 and the maximum score is 165. As the score obtained from the scale increases, women's fear of childbirth also increases (Korukcu vd., 2012; Korukcu vd., 2016).
Measured: The pre-test will be administered before randomisation and the post-test 2 hours after the delivery.
The Perception of Spousal Support in Pregnancy Scale
Measures pregnant women's perceived partner support. A minimum of 16 and a maximum of 80 points can be obtained from the scale. A higher score means higher perceived spousal support (Yurdakul vd., 2020).
Measured: The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start9 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- After meeting the couples, their eligibility for inclusion in the study will be assessed. Subsequently, couples who meet the inclusion criteria will be asked to read the informed consent form and provide verbal and written consent. Pre-tests will be administered to eligible couples, who will then be assigned to either the experimental group (Self-Efficacy Theory-Based Spouse Participation Childbirth Preparation Program) or the control group according to the block randomization list.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Nur Duman, Lokman Hekim University
- Investigators
- Zehra Gölbaşı, Ph.D., Study director, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453811
- Sponsor's protocol ID
- LHU_FND1
- Status last verified
- Sep 2025
- First submitted
- 1 Jun 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calpbinici P, Uzunkaya Oztoprak P, Terzioglu F, Ustun Y. The Fathers' Fear of Childbirth Scale: a Turkish validity and reliability study. J Reprod Infant Psychol. 2024 Jun;42(3):424-438. doi: 10.1080/02646838.2023.2225084. Epub 2023 Jun 13.
PubMed 37309993Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.
PubMed 22260727Korukcu O, Bulut O, Kukulu K. Psychometric Evaluation of the Wijma Delivery Expectancy/Experience Questionnaire Version B. Health Care Women Int. 2016;37(5):550-67. doi: 10.1080/07399332.2014.943838. Epub 2014 Oct 8.
PubMed 25119342Yurdakul M, Beşen MA, Alıcı, D. Development of the Perception of Spousal Support in Pregnancy Scale (PSSPS): Reliability and Validity Studies. Journal of Education and Research in Nursing. 2020; 17(1): 258-266.
Ersoy Y, Kukulu K. Validity and Reliability Study of Self-Efficacy in Labour and Delivery Scale [Master's Thesis]. Akdeniz University. 2011.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Self-Efficacy Theory-Based Spouse Participation Childbirth Preparation Program on Fear of Childbirth, Self-Efficacy, Mode of Delivery and Birth Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06453811
- Acronym / sponsor ID
- LHU_FND1
- Conditions
- Fear of Childbirth, Childbirth Self-Efficacy, Mode of Delivery, Childbirth Preparation Program
- Keywords
- Self-Efficacy, Childbirth Preparation, Fear of Childbirth, Mode of Delivery, Spousal Support, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 12 Jun 2024 (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 is designed as a pre-test, post-test, parallel-group, randomized controlled study to examine the effect of a spouse-participated childbirth preparation program based on self-efficacy theory on fear of childbirth, self-efficacy, mode of delivery and outcomes. Participants will be allocated to experimental and control groups through block randomization. Participants in the experimental group will be enrolled in a two-session spouse-participated childbirth preparation program based on self-efficacy theory once a week, in addition to receiving routine care at the hospital. Participants in the control group will not receive any intervention, only routine care provided at the hospital.
Detailed description
Nulliparous pregnant women and their spouses who apply to the obstetrics and gynecology clinic and outpatient clinic of the hospital where the research will be conducted will be assessed for eligibility according to the inclusion criteria, and informed consent will be obtained. Subsequently, prospective fathers will be given a Personal Information Form and the Fathers' Fear of Childbirth Scale; prospective mothers will be given a Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A, the Childbirth Self-Efficacy Inventory Short Form, and the Perception of Spousal Support in Pregnancy Scale as pre-tests. Couples will be allocated to the experimental or control group according to a block randomization list. Couples assigned to the experimental group will be included in a three-week program, attending a self-efficacy theory-based childbirth preparation program in groups of 3-4 couples, scheduled according to their availability. At the end of the sessions, the training guide reflecting the content of the training will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue routine pregnancy controls in the hospital. Routine pregnancy check-ups at the hospital include standard antenatal follow-ups, and pregnant women and their partners receive information about the pregnancy and labour process only during the medical examination. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message contents related to the training content will be used in the reminder. After completing the training, the Fathers' Fear of Childbirth Scale, the Childbirth Self-Efficacy Inventory Short Form, and the Perception of Spousal Support in Pregnancy Scale will be administered again. Following childbirth, the Wijma Delivery Expectancy/Experience Questionnaire Version B will be completed by the mothers, and the birth process information form will be filled out by the researcher. Couples in the control group will undergo the same pre-test and post-test assessments as the experimental group. However, no additional intervention will be provided to these couples, and they will receive the same routine care as the experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After meeting the couples, their eligibility for inclusion in the study will be assessed. Subsequently, couples who meet the inclusion criteria will be asked to read the informed consent form and provide verbal and written consent. Pre-tests will be administered to eligible couples, who will then be assigned to either the experimental group (Self-Efficacy Theory-Based Spouse Participation Childbirth Preparation Program) or the control group according to the block randomization list.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Self-efficacy Theory-based Childbirth Preparation ProgramAccording to the block randomisation method, the couples who are included in the experimental group by applying the pre-test will be included in the programme in groups of 3-4 couples by planning the day and time they can participate in the programme. At the end of the sessions, the training guide reflecting the training content will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue their routine pregnancy controls in the hospital. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message content related to the training content will be used in the reminder. |
| Control Group | No intervention | –No additional intervention will be provided to couples in the control group, and they will receive the routine care provided at the hospital. This routine care includes standard antenatal follow-ups, during which pregnant women and their spouses receive information about pregnancy and childbirth only during physician examinations. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Couples must be 18 years of age or older,
- Couples should be able to read and write Turkish,
- The pregnant woman has never given birth before,
- The pregnant woman is at 28-30 weeks of gestation,
- The pregnancy is viable and singular,
Key exclusion criteria (6 listed)
- Pregnancy achieved by assisted reproductive techniques,
- Participating in a birth preparation programme other than the routine pregnancy check-ups at the hospital,
- Failure to attend any of the sessions in the childbirth preparation programme,
- Failure to communicate in the postnatal period (no response to at least 3 telephone calls)
- Development of any indication for caesarean section during pregnancy,
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 |
|---|---|---|
| Self-efficacy Theory-based Childbirth Preparation ProgramAccording to the block randomisation method, the couples who are included in the experimental group by applying the pre-test will be included in the programme in groups of 3-4 couples by planning the day and time they can participate in the programme. At the end of the sessions, the training guide reflecting the training content will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue their routine pregnancy controls in the hospital. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message content related to the training content will be used in the reminder. | Other | Experimental Group |
Primary outcome
The Childbirth Self-Efficacy Inventory Short Form
Time frame: The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).
Measures the level of self-efficacy of expectant mothers in childbirth. The lowest score that can be obtained from the overall scale is 32 and the highest score is 320. The highest score obtained from the overall scale means that women's self-efficacy levels in childbirth are high (Ersoy \& Kukulu, 2011).
Birth Process Information Form
Time frame: It will be applied two hours after the expectant mother gives birth.
This form inquires about the mode of delivery and intervention at birth. One of the primary outcomes of the research is mode of delivery.
3 secondary outcomes
The Fathers' Fear of Childbirth Scale
Time frame: The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).
The Wijma Delivery Expectancy/Experience Questionnaire Version A-B
Time frame: The pre-test will be administered before randomisation and the post-test 2 hours after the delivery.
The Perception of Spousal Support in Pregnancy Scale
Time frame: The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).
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 4 Sep 2025.
- Background: PubMed 37309993Calpbinici P, Uzunkaya Oztoprak P, Terzioglu F, Ustun Y. The Fathers' Fear of Childbirth Scale: a Turkish validity and reliability study. J Reprod Infant Psychol. 2024 Jun;42(3):424-438. doi: 10.1080/02646838.2023.2225084. Epub 2023 Jun 13.
- Background: PubMed 22260727Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.
- Background: PubMed 25119342Korukcu O, Bulut O, Kukulu K. Psychometric Evaluation of the Wijma Delivery Expectancy/Experience Questionnaire Version B. Health Care Women Int. 2016;37(5):550-67. doi: 10.1080/07399332.2014.943838. Epub 2014 Oct 8.
- BackgroundYurdakul M, Beşen MA, Alıcı, D. Development of the Perception of Spousal Support in Pregnancy Scale (PSSPS): Reliability and Validity Studies. Journal of Education and Research in Nursing. 2020; 17(1): 258-266.
- BackgroundErsoy Y, Kukulu K. Validity and Reliability Study of Self-Efficacy in Labour and Delivery Scale [Master's Thesis]. Akdeniz University. 2011.
- 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.
Zehra Gölbaşı, Ph.D. study director
Lokman Hekim 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 Self-efficacy Theory-based Childbirth Preparation Program in people with Fear of Childbirth and Childbirth Self-Efficacy, run by Lokman Hekim 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 7 inclusion and 6 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 4 Sep 2025. 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?
The Childbirth Self-Efficacy Inventory Short Form (time frame: The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).). The study lists 2 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 NCT06453811, which also lists 5 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 4 Sep 2025.