Fear of ChildbirthNCT04740762
The Effect of Individual Counselling Program on Fear of Childbirth
A study testing Intervention group in people with Fear of Childbirth and Pregnancy Related, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
A randomized control trial was made to developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness. 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, Pregnancy Related
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 7 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
- Primiparas
- Ages between 18-35
- Lived in Aydın
- In gestational week 28-30,
- Pregnant with a single child
- Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)
- In a low-risk pregnancy (on the basis of the criteria of the Ministry of Health),
- Willing to divulge their own or their husband's telephone numbers,
Who cannot join
- High-risk pregnancy who had psychological and mental health problems
- History of infertility
- Speech and hearing disabilities
- Substance or narcotics users
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Individual Counselling Program in Coping With Fear of Childbirth: A Randomized Controlled Study
A randomized control trial was made to developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.
Read the detailed description
Fear of childbirth is a common problem among women and one that affects their health and welfare before and during pregnancy and in the postpartum period. The problem can lead to adverse pregnancy outcomes and also cause a woman to experience psychological issues. Fear of childbirth can also influence the determination of the mode of delivery and can amount to a rise in cesarean rates.
The healthcare provided by midwives and other healthcare professionals during pregnancy and childbirth have the power to reduce or exacerbate childbirth fears. The most significant midwifery intervention that can be used to diminish the fear of childbirth is counseling. There is a need to develop and test individual counseling models that require the basic training skills that midwives can use as part of their routine care to address women's fears and expectations about childbirth. The individual counseling program developed in this context may be an easy-to-implement and cost-effective method to use.
This study was conducted for the purposes of developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.
It was tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of fear of childbirth, childbirth self-efficacy and state anxiety scores and childbirth outcomes (duration of labor, mode of delivery, elective and emergency cesarean rates, postpartum hypertension and need for a blood transfusion, the admittance of the newborn into the intensive care unit, preferences for future births and duration of stay in hospital).
- Conditions
- Fear of Childbirth, Pregnancy Related
- Being tested
- Intervention group
- Keywords
- Prenatal care, Fear, Childbirth, Counseling, Midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
The women in the intervention groups were administered a three-session intervention program in addition to the routine care they received.The program encompassed providing the women with an educational booklet, childbirth stories and childbirth videos that were created to reduce their fears of childbirth.The interviews were held a total of three times, in gestational weeks 28-30, 31-33 and 34-36. The duration of the intervention at each visit was 60-80 minutes. Depending on the woman's own preference, she was invited to visit the delivery room at the second or last session and meet the midwives there. The women who did not wish to go to the delivery room were alternatively provided with photographs of the delivery room so they could take a look. Again as part of the education program, the women were given the links to the selected childbirth videos and given the opportunity to watch them.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The study group were provided with individual counseling program and followed in this study, in addition to the usual care provided by healthcare professionals. Receives: Behavioral: Intervention group |
| Control group | No intervention | The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of childbirth before intervention
assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.
Measured: 28-30 gestational weeks
Fear of childbirth after intervention
assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.
Measured: 36-38 gestational weeks
Fear of childbirth after birth
assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version B. This instrument contains questions on women's postpartum experiences to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel after their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version-B is based on a 6-point Likert scale where the responses are numbered from 1-6 and one corresponds to the response, "Totally" and six means "none." The total possible score on the scale varies between 33-198. Higher scores indicate greater levels of Fear of Childbirth.
Measured: 12th-24th hour after the birth
Childbirth Self-Efficacy before intervention
assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.
Measured: 28-30 gestational weeks
Childbirth Self-Efficacy after intervention
assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.
Measured: 36-38 gestational weeks
State Anxiety before intervention
assessed using the State Anxiety Inventory. The instrument is composed of 20 items. The total possible score on the instrument varies between 20-80. The measurements according to the State Anxiety Inventory scores indicate no anxiety at a score of 0-19, moderate anxiety at 20-39, a high level of anxiety at 40-59, severe anxiety at 60-79 and panic-evoking anxiety at 80 and above.
Measured: 28-30 gestational weeks
State Anxiety after intervention
assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.
Measured: 36-38 gestational weeks
Duration of labor
used to determine the duration of labor. Duration of labor was recorded by the researcher to postpartum questionnaire as hours from hospital record.
Measured: 12th-24th hour after the birth
Mode of Delivery
used to determine the mode of delivery. Mode of delivery was recorded by the researcher to the postpartum questionnaire as vaginal or cesarean section.
Measured: 12th-24th hour after the birth
Elective and Emergency Cesarean Rates
used to determine the elective and emergency cesarean rates. Elective and emergency cesarean rates were recorded by the researcher to postpartum questionnaires as yes or no from hospital record.
Measured: 12th-24th hour after the birth
Secondary outcomes (4)
Postpartum hypertension
used to determine postpartum hypertension. Postpartum hypertension was recorded by the researcher to postpartum questionnaires as yes or no from hospital record.
Measured: 12th-24th hour after the birth
Need for a blood transfusion
used to determine needing for a blood transfusion. Needing for a blood transfusion was recorded by the researcher from hospital record to postpartum questionnaires as yes or no depending on whether there was a blood transfusion.
Measured: 12th-24th hour after the birth
Admittance of the Newborn into the Intensive Care Unit
used to determine the admittance of the newborn into the intensive care unit. Admittance of the Newborn into the Intensive Care Unit was recorded by the researcher from hospital records to postpartum questionnaires as yes or no depending on whether the baby was in intensive care.
Measured: 12th-24th hour after the birth
Preferences for Future Births
used to determine the preferences for future births. Preferences for future births was measured and recorded by the researcher to postpartum questionnaires as vaginal or cesarean section.
Measured: 12th-24th hour after the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Sep 2018
- Primary completion7 May 2020
- Study completion7 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 Aydin Adnan Menderes 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
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Öztürk, Aydin Adnan Menderes University
- Investigators
- Gizem Öztürk, PhD, Study chair, Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740762
- Sponsor's protocol ID
- Interventional study
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Individual Counselling Program in Coping With Fear of Childbirth: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04740762
- Acronym / sponsor ID
- Interventional study
- Conditions
- Fear of Childbirth, Pregnancy Related
- Keywords
- Prenatal care, Fear, Childbirth, Counseling, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 5 Feb 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.
A randomized control trial was made to developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.
Detailed description
Fear of childbirth is a common problem among women and one that affects their health and welfare before and during pregnancy and in the postpartum period. The problem can lead to adverse pregnancy outcomes and also cause a woman to experience psychological issues. Fear of childbirth can also influence the determination of the mode of delivery and can amount to a rise in cesarean rates.
The healthcare provided by midwives and other healthcare professionals during pregnancy and childbirth have the power to reduce or exacerbate childbirth fears. The most significant midwifery intervention that can be used to diminish the fear of childbirth is counseling. There is a need to develop and test individual counseling models that require the basic training skills that midwives can use as part of their routine care to address women's fears and expectations about childbirth. The individual counseling program developed in this context may be an easy-to-implement and cost-effective method to use.
This study was conducted for the purposes of developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.
It was tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of fear of childbirth, childbirth self-efficacy and state anxiety scores and childbirth outcomes (duration of labor, mode of delivery, elective and emergency cesarean rates, postpartum hypertension and need for a blood transfusion, the admittance of the newborn into the intensive care unit, preferences for future births and duration of stay in hospital).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupThe study group were provided with individual counseling program and followed in this study, in addition to the usual care provided by healthcare professionals. |
| Control group | No intervention | –The control group continued to receive the routine care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Primiparas
- Ages between 18-35
- Lived in Aydın
- In gestational week 28-30,
- Pregnant with a single child
Key exclusion criteria (4 listed)
- High-risk pregnancy who had psychological and mental health problems
- History of infertility
- Speech and hearing disabilities
- Substance or narcotics users
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 |
|---|---|---|
| Intervention groupThe women in the intervention groups were administered a three-session intervention program in addition to the routine care they received.The program encompassed providing the women with an educational booklet, childbirth stories and childbirth videos that were created to reduce their fears of childbirth.The interviews were held a total of three times, in gestational weeks 28-30, 31-33 and 34-36. The duration of the intervention at each visit was 60-80 minutes. Depending on the woman's own preference, she was invited to visit the delivery room at the second or last session and meet the midwives there. The women who did not wish to go to the delivery room were alternatively provided with photographs of the delivery room so they could take a look. Again as part of the education program, the women were given the links to the selected childbirth videos and given the opportunity to watch them. | Behavioural | Intervention group |
Primary outcome
Fear of childbirth before intervention
Time frame: 28-30 gestational weeks
assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.
Fear of childbirth after intervention
Time frame: 36-38 gestational weeks
assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.
Fear of childbirth after birth
Time frame: 12th-24th hour after the birth
assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version B. This instrument contains questions on women's postpartum experiences to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel after their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version-B is based on a 6-point Likert scale where the responses are numbered from 1-6 and one corresponds to the response, "Totally" and six means "none." The total possible score on the scale varies between 33-198. Higher scores indicate greater levels of Fear of Childbirth.
Childbirth Self-Efficacy before intervention
Time frame: 28-30 gestational weeks
assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.
Childbirth Self-Efficacy after intervention
Time frame: 36-38 gestational weeks
assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.
State Anxiety before intervention
Time frame: 28-30 gestational weeks
assessed using the State Anxiety Inventory. The instrument is composed of 20 items. The total possible score on the instrument varies between 20-80. The measurements according to the State Anxiety Inventory scores indicate no anxiety at a score of 0-19, moderate anxiety at 20-39, a high level of anxiety at 40-59, severe anxiety at 60-79 and panic-evoking anxiety at 80 and above.
State Anxiety after intervention
Time frame: 36-38 gestational weeks
assessed using the Childbirth Self-efficacy Inventory-Short Form. The instrument measure levels of self-efficacy during labor. The scale is comprised of two subscales-outcome expectancies and self-efficacy expectancies. In the outcome expectancies subscale, responses range from 1: "not at all helpful" to 10: "very helpful," while in the self-efficacy expectancies subscale, the first 13 items are marked as 1: "Completely sure," to 10: "Not at all sure" and items 14-16 receive a score of 1: "Not at all sure" to 10: "Completely sure." All the responses to the inventory are based on a 10-point Likert-type scale. The lowest possible score on the Childbirth Self-efficacy Inventory is 32; the highest is 320. The higher the score, the more self-efficacy and confidence the pregnant woman has.
Duration of labor
Time frame: 12th-24th hour after the birth
used to determine the duration of labor. Duration of labor was recorded by the researcher to postpartum questionnaire as hours from hospital record.
Mode of Delivery
Time frame: 12th-24th hour after the birth
used to determine the mode of delivery. Mode of delivery was recorded by the researcher to the postpartum questionnaire as vaginal or cesarean section.
Elective and Emergency Cesarean Rates
Time frame: 12th-24th hour after the birth
used to determine the elective and emergency cesarean rates. Elective and emergency cesarean rates were recorded by the researcher to postpartum questionnaires as yes or no from hospital record.
4 secondary outcomes
Postpartum hypertension
Time frame: 12th-24th hour after the birth
Need for a blood transfusion
Time frame: 12th-24th hour after the birth
Admittance of the Newborn into the Intensive Care Unit
Time frame: 12th-24th hour after the birth
Preferences for Future Births
Time frame: 12th-24th hour after the birth
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 5 Feb 2021.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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.
Gizem Öztürk, PhD study chair
Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Fear of Childbirth and Pregnancy Related, run by Aydin Adnan Menderes 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 4 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 5 Feb 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?
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?
Fear of childbirth before intervention (time frame: 28-30 gestational weeks). The study lists 10 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 5 Feb 2021.