Fear of ChildbirthNCT04660981
The Effect of the Training Program Provided to Primipara Pregnant Women Through the Motivational Interview Method on Their Fear of Childbirth, Childbirth Self-Efficacy and Delivery Mode
A study testing Antenatal education in people with Fear of Childbirth and Childbirth Self-efficacy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This two-group, parallel randomized controlled study was conducted to evaluate the effect of the training program provided to primipara pregnant women through the motivational interview method on their fear of childbirth, childbirth self-efficacy and delivery mode. 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, Childbirth Self-efficacy, Mode of Delivery
- What is being tested?
- Antenatal education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2019to 15 May 2020
- 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
- Ability to read and write in Turkish
- Not contraindicated for vaginal delivery
- Absence of any pregnancy-related complications
- Absence of chronic systemic disease
- Absence of communication problems
- Absence of psychiatric problems
- No abnormalities in the fetus
- 24th and 28th weeks of pregnancy
Who cannot join
- Premature birth (before 37th weeks of gestation)
- Pregnancy complication developed at any stage of the study (such as preeclampsia, placenta previa, oligohydramnios, gestational diabetes)
- A cesarean section is planned at any stage of the study due to a medical indication,
- Did not complete the training program
- Giving birth outside the province
- Not seen within 24 hours after birth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Nursing
Ankara
About this study
Official title: The Effect of the Training Program Provided to Primipara Pregnant Women Through the Motivational Interview Method on Their Fear of Childbirth, Childbirth Self-Efficacy and Delivery Mode: A Randomized Controlled Study
This two-group, parallel randomized controlled study was conducted to evaluate the effect of the training program provided to primipara pregnant women through the motivational interview method on their fear of childbirth, childbirth self-efficacy and delivery mode. The primipara pregnant women included in the study sample were assigned to the intervention (n=37) and control (n=36) groups using the block randomization method. The women in the intervention group were individually provided with "Training Program on Fear of Childbirth Based on Motivational Interview Method" once a week, four sessions in total, while no interventions were made for those in the control group other than routine hospital practices. Study data were collected using a descriptive information form, the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) versions A-B, the Childbirth Self-Efficacy Inventory-Short Form (CBSEI-SF) and the Delivery Evaluation Form. The value of p<0.05 was accepted statistically significant in the data analyses.
- Being tested
- Antenatal education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal educationBehavioural
Training Program on Fear of Childbirth Based on Motivational Interview Method
| Study group | Role | What they receive |
|---|---|---|
| İntervention Group | Experimental | The women in the intervention group were individually provided with "Training Program on Fear of Childbirth Based on Motivational Interview Method" once a week, four sessions in total. Receives: Behavioral: Antenatal education |
| Control Group | No intervention | No interventions were made for those in the control group other than routine hospital practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) A version
W-DEQ Version A, which was developed in Sweden in 1998 by Wijma and Klaas, was adapted into Turkish by Körükçü et al. in 2009. It is a 6-point Likert type scale and consists of 33 items. The answers in the scale are scored from 0 to 5, with 0 indicating "completely" and 5 indicating "none." The minimum score on the scale is 0, whereas the maximum score is 165. A high total score indicates a high level of fear; 85 points are considered as the cut-off value. A score of ≥85 indicates clinical level fear.
Measured: Change from the WDEQ A scores at pre-training (24th and 28th gestational week), post-training (4 weeks later) and 37th and 40th gestational week
Childbirth Self-Efficacy Inventory-Short Form (CBSEI-SF)
The short form of the Childbirth Self-efficacy Inventory has two subscales: outcome expectancy and efficacy expectancy (Ip, et al., 2008). Efficacy expectancy (EE) is a personal conviction about one's ability to successfully perform the required behaviors in a given situation, and outcome expectancy (OE) is the belief that a given behavior will lead to a given outcome. Each subscale consists of 16 items and yields a score between 16 and 160. Higher scores indicate higher levels of efficacy or outcome efficacy for birth.
Measured: Change from the CBSEI-SF scores at pre-training (24th and 28th gestational week), post-training (4 weeks later) and 37th and 40th gestational week
The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) B version
The W-DEQ-B was created by Wijma and et al. to evaluate intrapartum childbirth fear in the postpartum period. The validity and reliability study of the scale was conducted by Körükçü et al. It is composed of 32 items. It uses a 6-point Likert scale: 0 corresponds to completely, and 5 corresponds to never. The lowest and the highest scores for the scale are 0 and 160, respectively.
Measured: W-DEQ-B scores at postpartum first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start2 Aug 2019
- Primary completion25 Feb 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Calpbinici, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660981
- Sponsor's protocol ID
- 2018.05.48
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Training Program Provided to Primipara Pregnant Women Through the Motivational Interview Method on Their Fear of Childbirth, Childbirth Self-Efficacy and Delivery Mode: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04660981
- Acronym / sponsor ID
- 2018.05.48
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 9 Dec 2020 (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.
This two-group, parallel randomized controlled study was conducted to evaluate the effect of the training program provided to primipara pregnant women through the motivational interview method on their fear of childbirth, childbirth self-efficacy and delivery mode. The primipara pregnant women included in the study sample were assigned to the intervention (n=37) and control (n=36) groups using the block randomization method. The women in the intervention group were individually provided with "Training Program on Fear of Childbirth Based on Motivational Interview Method" once a week, four sessions in total, while no interventions were made for those in the control group other than routine hospital practices. Study data were collected using a descriptive information form, the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) versions A-B, the Childbirth Self-Efficacy Inventory-Short Form (CBSEI-SF) and the Delivery Evaluation Form. The value of p<0.05 was accepted statistically significant in the data analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention Group | Experimental | Behavioral: Antenatal educationThe women in the intervention group were individually provided with "Training Program on Fear of Childbirth Based on Motivational Interview Method" once a week, four sessions in total. |
| Control Group | No intervention | –No interventions were made for those in the control group other than routine hospital practices. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ability to read and write in Turkish
- Not contraindicated for vaginal delivery
- Absence of any pregnancy-related complications
- Absence of chronic systemic disease
- Absence of communication problems
Key exclusion criteria (6 listed)
- Premature birth (before 37th weeks of gestation)
- Pregnancy complication developed at any stage of the study (such as preeclampsia, placenta previa, oligohydramnios, gestational diabetes)
- A cesarean section is planned at any stage of the study due to a medical indication,
- Did not complete the training program
- Giving birth outside the province
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 |
|---|---|---|
| Antenatal educationTraining Program on Fear of Childbirth Based on Motivational Interview Method | Behavioural | İntervention Group |
Primary outcome
Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) A version
Time frame: Change from the WDEQ A scores at pre-training (24th and 28th gestational week), post-training (4 weeks later) and 37th and 40th gestational week
W-DEQ Version A, which was developed in Sweden in 1998 by Wijma and Klaas, was adapted into Turkish by Körükçü et al. in 2009. It is a 6-point Likert type scale and consists of 33 items. The answers in the scale are scored from 0 to 5, with 0 indicating "completely" and 5 indicating "none." The minimum score on the scale is 0, whereas the maximum score is 165. A high total score indicates a high level of fear; 85 points are considered as the cut-off value. A score of ≥85 indicates clinical level fear.
Childbirth Self-Efficacy Inventory-Short Form (CBSEI-SF)
Time frame: Change from the CBSEI-SF scores at pre-training (24th and 28th gestational week), post-training (4 weeks later) and 37th and 40th gestational week
The short form of the Childbirth Self-efficacy Inventory has two subscales: outcome expectancy and efficacy expectancy (Ip, et al., 2008). Efficacy expectancy (EE) is a personal conviction about one's ability to successfully perform the required behaviors in a given situation, and outcome expectancy (OE) is the belief that a given behavior will lead to a given outcome. Each subscale consists of 16 items and yields a score between 16 and 160. Higher scores indicate higher levels of efficacy or outcome efficacy for birth.
The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) B version
Time frame: W-DEQ-B scores at postpartum first day
The W-DEQ-B was created by Wijma and et al. to evaluate intrapartum childbirth fear in the postpartum period. The validity and reliability study of the scale was conducted by Körükçü et al. It is composed of 32 items. It uses a 6-point Likert scale: 0 corresponds to completely, and 5 corresponds to never. The lowest and the highest scores for the scale are 0 and 160, respectively.
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 9 Dec 2020.
- Individual participant dataSharing planned: No. There are no plans.
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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 Antenatal education in people with Fear of Childbirth and Childbirth Self-efficacy, run by Hacettepe 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 8 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 9 Dec 2020. 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?
Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) A version (time frame: Change from the WDEQ A scores at pre-training (24th and 28th gestational week), post-training (4 weeks later) and 37th and 40th gestational week). 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?
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 9 Dec 2020.