Fear of ChildbirthNCT04173351
The Effects of Antenatal Education and Counseling on Childbirth Fear of Nulliparous Women
A study testing Education and Counseling in people with Fear of Childbirth, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Trial summary
This study investigates the effects of antenatal education and counseling on childbirth preparation and pain management given to nulliparous women during the last trimester on their childbirth fear and childbirth attitudes. 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
- What is being tested?
- Education and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2016to 15 Jan 2017
- 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
- Nulliparity
- 28-34th gestational age
- Single fetus
- not receive IVF treatment
- Normal vaginal birth
Who cannot join
- Caesarean section
About this study
Official title: The Effects of Antenatal Education and Counseling on Childbirth Fear of Nulliparous Women and Their Attitudes Towards Childbirth
This study investigates the effects of antenatal education and counseling on childbirth preparation and pain management given to nulliparous women during the last trimester on their childbirth fear and childbirth attitudes.
Read the detailed description
Pregnancy is an important period of life that the pregnant women have biological, physiological, emotional and social changes in order to adapt to maternity. Fear of childbirth is a common problem and has a negative impact on the childbirth experience. The prevalence of fear associated with childbirth is around 20% but approximately 6 to 10% of women experience intense fear of labour. In Turkey, it estimated that the prevalence of childbirth fear among the Turkish pregnant women was approximately 21% . Fear of childbirth can cause significant problems during childbirth and the postpartum period. This fear is commonly associated with concern for the baby, pain in childbirth, longer first and second stage of labour and dissatisfaction with the childbirth experiences. Especially nulliparous women experience fear of childbirth more than multipar women. Fear of childbirth has also been implicated in women's requests for caesarean sections and increased rate of elective caesarean sections. Antenatal education is an essential health service throughout the world. Antenatal education during the last trimester may decrease childbirth fear. Also, pregnant women who received antenatal education, had a positive birth experience, better maternal adjustment and fewer symptoms of postnatal depression. The aim of this study was to investigate the effects of antenatal education and counseling on childbirth preparation and pain management given to nulliparous women during the last trimester on their childbirth fear and childbirth attitudes.
This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between February 2016 and January 2017. 132 nulliparous women between the 28th and 34th gestational weeks constituted the sample of the study. Data was collected by using personal information questionnaire, the Wijma Delivery Expectancy/Experience Questionairre (W-DEQ) Version A, W-DEQ Version B, and Childbirth Attitudes Questionairre (CAQ). Following the pretest, participants in the intervention group received childbirth preparation education and telephone counseling. Participants in the control group received no intervention other than the routine antenatal follow-up. For both groups, pretest and posttest were conducted during the same days, antenatal evaluation took place between the 38th and the 40th gestational weeks and postnatal evaluation was conducted during the first and the second postnatal days. The IBM SPSS (Statistical package for the Social Sciences) 22.0 package program was used to evaluate the data obtained in the study.
- Conditions
- Fear of Childbirth
- Being tested
- Education and Counseling
- Keywords
- childbirth, nulliparous, childbirth fear, antenatal education, counseling, attitude, pain
- Medical subject headings
- Behavior, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and CounselingBehavioural
Following the pretests between the 28th and the 34th gestational weeks, nulliparous women in the intervention group received a presentation on childbirth preparation at a room of the obstetrics clinic. The education was completed in two sections in a single day. Each session took about 45 minutes there was a 15-minute break between the sessions. Following the education, the questions of the participants were responded and educational brochures on childbirth preparation were given to the participants. One of the researchers of this study telephoned the participant women in the intervention group one week after the childbirth education and provided counseling service about the demands and the points that the nulliparous women wondered.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pregnant women in intervention group completed the PIQ, W-DEQ-A and CAQ between the 28th and the 34th gestational weeks. Date of the next antenatal follow-up of the participants in the intervention group was recorded and they were given an appointment for the antenatal education. Women, whose date of next antenatal follow-up was unknown, were asked to inform the researchers about their appointment. Following the antenatal follow-up, the pregnant women in the intervention group were given an antenatal childbirth education and an educational brochure after the education. Also, provided telephone counseling to the intervention group one week after the education. Participants in the intervention group filled the W-DEQ-A and CAQ during the 38th and the 40th gestational weeks. Finally, were completed the W-DEQ-B during the first and the second postnatal days. Receives: Behavioral: Education and Counseling |
| Control | No intervention | Pregnant women in control group completed the PIQ, W-DEQ-A and CAQ between the 28th and the 34th gestational weeks. Participants in the control group filled the W-DEQ-A and CAQ during the 38th and the 40th gestational weeks. Finally, were completed the W-DEQ-B during the first and the second postnatal days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Delivery Expectancy/Experience Questionairre (Version A) (W-DEQ-A)
Participants filled before and after education and counseling W-DEQ-A was developed by Klaas and Barbro Wijma in Sweden in 1998. Cronbach's alpha of the scale was 0.88 for primiparous women. The scale consisted of 33 items, which are rated on a six-point Likert type scale (zero=do not agree; five=totally agree). Items 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 were reverse-scored to calculate the women's individual total score. Higher scores indicated greater fear that the pregnant women experienced. Cutting score of the questionnaire was 85.
Measured: 10 minutes
Wijma Delivery Expectancy/Experience Questionairre (Version B) (W-DEQ-B)
Participants filled on the first and second days of postpartum W-DEQ-B was developed by Klaas and Barbro Wijma in 1998 in order to determine postpartum pains and the feelings and thoughts of women after childbirth. The questionnaire included 32 items rated on a six-point Likert type scale (zero=not at all; five=extremely). Items 2, 3, 6, 7, 10, 11, 14, 18, 19, 23, 24, 26, and, 30 were reverse scored and higher scores indicated greater postnatal fear of childbirth. The questionnaire had six subscales, namely, concerns about labor pain, loneliness, lack of positive feelings, concerns about childbirth, and concerns about baby.
Measured: 10 minutes
Childbirth Attitudes Questionnaire (CAQ)
Participants filled before and after education and counseling CAQ was developed by Lowe in 2000 in order to measure the fear of childbirth. Cronbach's alpha of the scale was 0.83. The questionnaire included 16 items rated on a four-point Likert type scale. Higher scores indicated greater fear.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start15 Feb 2016
- Primary completion15 Jan 2017
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between February 2016 and January 2017. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gulten Guvenc, Prof. Dr., Principal investigator, University of Health Sciences, Gulhane Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173351
- Sponsor's protocol ID
- 50687469-1491
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Ryding EL, Saisto T. Group psychoeducation with relaxation for severe fear of childbirth improves maternal adjustment and childbirth experience--a randomised controlled trial. J Psychosom Obstet Gynaecol. 2015;36(1):1-9. doi: 10.3109/0167482X.2014.980722. Epub 2014 Nov 24.
PubMed 25417935Gokce Isbir G, Inci F, Onal H, Yildiz PD. The effects of antenatal education on fear of childbirth, maternal self-efficacy and post-traumatic stress disorder (PTSD) symptoms following childbirth: an experimental study. Appl Nurs Res. 2016 Nov;32:227-232. doi: 10.1016/j.apnr.2016.07.013. Epub 2016 Jul 30.
PubMed 27969033Hauck YL, Stoll KH, Hall WA, Downie J. Association between childbirth attitudes and fear on birth preferences of a future generation of Australian parents. Women Birth. 2016 Dec;29(6):511-517. doi: 10.1016/j.wombi.2016.05.001. Epub 2016 May 24.
PubMed 27233945Haapio S, Kaunonen M, Arffman M, Astedt-Kurki P. Effects of extended childbirth education by midwives on the childbirth fear of first-time mothers: an RCT. Scand J Caring Sci. 2017 Jun;31(2):293-301. doi: 10.1111/scs.12346. Epub 2016 Jul 21.
PubMed 27439382Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y.
PubMed 26518597Deliktas A, Kukulu K. Pregnant Women in Turkey Experience Severe Fear of Childbirth: A Systematic Review and Meta-Analysis. J Transcult Nurs. 2019 Sep;30(5):501-511. doi: 10.1177/1043659618823905. Epub 2019 Jan 17.
PubMed 30651038Karabulut O, Coskuner Potur D, Dogan Merih Y, Cebeci Mutlu S, Demirci N. Does antenatal education reduce fear of childbirth? Int Nurs Rev. 2016 Mar;63(1):60-7. doi: 10.1111/inr.12223. Epub 2015 Nov 27.
PubMed 26612181Bektas Pardes B, Guvenc G. The effects of antenatal education and telephone counseling on childbirth fear of nulliparous women and their attitudes toward childbirth: a randomized controlled trial. Rev Assoc Med Bras (1992). 2025 Mar 17;71(1):e20241147. doi: 10.1590/1806-9282.20241147. eCollection 2025.
PubMed 40105556
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Antenatal Education and Counseling on Childbirth Fear of Nulliparous Women and Their Attitudes Towards Childbirth
- ClinicalTrials.gov ID
- NCT04173351
- Acronym / sponsor ID
- 50687469-1491
- Conditions
- Fear of Childbirth
- Keywords
- childbirth, nulliparous, childbirth fear, antenatal education, counseling, attitude, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 21 Nov 2019 (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 study investigates the effects of antenatal education and counseling on childbirth preparation and pain management given to nulliparous women during the last trimester on their childbirth fear and childbirth attitudes.
Detailed description
Pregnancy is an important period of life that the pregnant women have biological, physiological, emotional and social changes in order to adapt to maternity. Fear of childbirth is a common problem and has a negative impact on the childbirth experience. The prevalence of fear associated with childbirth is around 20% but approximately 6 to 10% of women experience intense fear of labour. In Turkey, it estimated that the prevalence of childbirth fear among the Turkish pregnant women was approximately 21% . Fear of childbirth can cause significant problems during childbirth and the postpartum period. This fear is commonly associated with concern for the baby, pain in childbirth, longer first and second stage of labour and dissatisfaction with the childbirth experiences. Especially nulliparous women experience fear of childbirth more than multipar women. Fear of childbirth has also been implicated in women's requests for caesarean sections and increased rate of elective caesarean sections. Antenatal education is an essential health service throughout the world. Antenatal education during the last trimester may decrease childbirth fear. Also, pregnant women who received antenatal education, had a positive birth experience, better maternal adjustment and fewer symptoms of postnatal depression. The aim of this study was to investigate the effects of antenatal education and counseling on childbirth preparation and pain management given to nulliparous women during the last trimester on their childbirth fear and childbirth attitudes.
This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between February 2016 and January 2017. 132 nulliparous women between the 28th and 34th gestational weeks constituted the sample of the study. Data was collected by using personal information questionnaire, the Wijma Delivery Expectancy/Experience Questionairre (W-DEQ) Version A, W-DEQ Version B, and Childbirth Attitudes Questionairre (CAQ). Following the pretest, participants in the intervention group received childbirth preparation education and telephone counseling. Participants in the control group received no intervention other than the routine antenatal follow-up. For both groups, pretest and posttest were conducted during the same days, antenatal evaluation took place between the 38th and the 40th gestational weeks and postnatal evaluation was conducted during the first and the second postnatal days. The IBM SPSS (Statistical package for the Social Sciences) 22.0 package program was used to evaluate the data obtained in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between February 2016 and January 2017. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Education and CounselingPregnant women in intervention group completed the PIQ, W-DEQ-A and CAQ between the 28th and the 34th gestational weeks. Date of the next antenatal follow-up of the participants in the intervention group was recorded and they were given an appointment for the antenatal education. Women, whose date of next antenatal follow-up was unknown, were asked to inform the researchers about their appointment. Following the antenatal follow-up, the pregnant women in the intervention group were given an antenatal childbirth education and an educational brochure after the education. Also, provided telephone counseling to the intervention group one week after the education. Participants in the intervention group filled the W-DEQ-A and CAQ during the 38th and the 40th gestational weeks. Finally, were completed the W-DEQ-B during the first and the second postnatal days. |
| Control | No intervention | –Pregnant women in control group completed the PIQ, W-DEQ-A and CAQ between the 28th and the 34th gestational weeks. Participants in the control group filled the W-DEQ-A and CAQ during the 38th and the 40th gestational weeks. Finally, were completed the W-DEQ-B during the first and the second postnatal days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Nulliparity
- 28-34th gestational age
- Single fetus
- not receive IVF treatment
- Normal vaginal birth
Key exclusion criteria (1 listed)
- Caesarean section
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 |
|---|---|---|
| Education and CounselingFollowing the pretests between the 28th and the 34th gestational weeks, nulliparous women in the intervention group received a presentation on childbirth preparation at a room of the obstetrics clinic. The education was completed in two sections in a single day. Each session took about 45 minutes there was a 15-minute break between the sessions. Following the education, the questions of the participants were responded and educational brochures on childbirth preparation were given to the participants. One of the researchers of this study telephoned the participant women in the intervention group one week after the childbirth education and provided counseling service about the demands and the points that the nulliparous women wondered. | Behavioural | Intervention |
Primary outcome
Wijma Delivery Expectancy/Experience Questionairre (Version A) (W-DEQ-A)
Time frame: 10 minutes
Participants filled before and after education and counseling W-DEQ-A was developed by Klaas and Barbro Wijma in Sweden in 1998. Cronbach's alpha of the scale was 0.88 for primiparous women. The scale consisted of 33 items, which are rated on a six-point Likert type scale (zero=do not agree; five=totally agree). Items 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 were reverse-scored to calculate the women's individual total score. Higher scores indicated greater fear that the pregnant women experienced. Cutting score of the questionnaire was 85.
Wijma Delivery Expectancy/Experience Questionairre (Version B) (W-DEQ-B)
Time frame: 10 minutes
Participants filled on the first and second days of postpartum W-DEQ-B was developed by Klaas and Barbro Wijma in 1998 in order to determine postpartum pains and the feelings and thoughts of women after childbirth. The questionnaire included 32 items rated on a six-point Likert type scale (zero=not at all; five=extremely). Items 2, 3, 6, 7, 10, 11, 14, 18, 19, 23, 24, 26, and, 30 were reverse scored and higher scores indicated greater postnatal fear of childbirth. The questionnaire had six subscales, namely, concerns about labor pain, loneliness, lack of positive feelings, concerns about childbirth, and concerns about baby.
Childbirth Attitudes Questionnaire (CAQ)
Time frame: 5 minutes
Participants filled before and after education and counseling CAQ was developed by Lowe in 2000 in order to measure the fear of childbirth. Cronbach's alpha of the scale was 0.83. The questionnaire included 16 items rated on a four-point Likert type scale. Higher scores indicated greater fear.
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 21 Nov 2019.
- Background: PubMed 25417935Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Ryding EL, Saisto T. Group psychoeducation with relaxation for severe fear of childbirth improves maternal adjustment and childbirth experience--a randomised controlled trial. J Psychosom Obstet Gynaecol. 2015;36(1):1-9. doi: 10.3109/0167482X.2014.980722. Epub 2014 Nov 24.
- Background: PubMed 27969033Gokce Isbir G, Inci F, Onal H, Yildiz PD. The effects of antenatal education on fear of childbirth, maternal self-efficacy and post-traumatic stress disorder (PTSD) symptoms following childbirth: an experimental study. Appl Nurs Res. 2016 Nov;32:227-232. doi: 10.1016/j.apnr.2016.07.013. Epub 2016 Jul 30.
- Background: PubMed 27233945Hauck YL, Stoll KH, Hall WA, Downie J. Association between childbirth attitudes and fear on birth preferences of a future generation of Australian parents. Women Birth. 2016 Dec;29(6):511-517. doi: 10.1016/j.wombi.2016.05.001. Epub 2016 May 24.
- Background: PubMed 27439382Haapio S, Kaunonen M, Arffman M, Astedt-Kurki P. Effects of extended childbirth education by midwives on the childbirth fear of first-time mothers: an RCT. Scand J Caring Sci. 2017 Jun;31(2):293-301. doi: 10.1111/scs.12346. Epub 2016 Jul 21.
- Background: PubMed 26518597Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y.
- Background: PubMed 30651038Deliktas A, Kukulu K. Pregnant Women in Turkey Experience Severe Fear of Childbirth: A Systematic Review and Meta-Analysis. J Transcult Nurs. 2019 Sep;30(5):501-511. doi: 10.1177/1043659618823905. Epub 2019 Jan 17.
- Background: PubMed 26612181Karabulut O, Coskuner Potur D, Dogan Merih Y, Cebeci Mutlu S, Demirci N. Does antenatal education reduce fear of childbirth? Int Nurs Rev. 2016 Mar;63(1):60-7. doi: 10.1111/inr.12223. Epub 2015 Nov 27.
- Derived from this study: PubMed 40105556Bektas Pardes B, Guvenc G. The effects of antenatal education and telephone counseling on childbirth fear of nulliparous women and their attitudes toward childbirth: a randomized controlled trial. Rev Assoc Med Bras (1992). 2025 Mar 17;71(1):e20241147. doi: 10.1590/1806-9282.20241147. eCollection 2025.
- 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.
Gulten Guvenc, Prof. Dr. principal investigator
University of Health Sciences, Gulhane Faculty of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Education and Counseling in people with Fear of Childbirth, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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 5 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: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Questionairre (Version A) (W-DEQ-A) (time frame: 10 minutes). 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 NCT04173351, which also lists 8 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 21 Nov 2019.