NCT04173351

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

November 20, 2019

Last Update Submit

November 20, 2019

Conditions

Keywords

childbirthnulliparouschildbirth fearantenatal educationcounselingattitudepain

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    5 minutes

Study Arms (2)

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.

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.

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNulliparous pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparity
  • th gestational age
  • Single fetus
  • not receive IVF treatment
  • Normal vaginal birth

You may not qualify if:

  • Caesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 25417935BACKGROUND
  • Gokce 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.

    PMID: 27969033BACKGROUND
  • Hauck 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.

    PMID: 27233945BACKGROUND
  • Haapio 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.

    PMID: 27439382BACKGROUND
  • Fenwick 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.

    PMID: 26518597BACKGROUND
  • Deliktas 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.

    PMID: 30651038BACKGROUND
  • Karabulut 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.

    PMID: 26612181BACKGROUND
  • Bektas 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.

MeSH Terms

Conditions

BehaviorPain

Interventions

Educational StatusCounseling

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gulten Guvenc, Prof. Dr.

    University of Health Sciences, Gulhane Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 21, 2019

Study Start

February 15, 2016

Primary Completion

January 15, 2017

Study Completion

January 15, 2017

Last Updated

November 21, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share