NCT04833842

Brief Summary

Pregnants who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, had a higher perception of birth self-efficacy than those who did not pass. Pregnant women who underwent a web-based preparation for labor program, which was developed based on a health belief model and supported by motivational interviews, had a more positive perception of birth than those who did not pass. The level of fear experienced at birth is lower in pregnant women who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews. The frequency of voluntary cesarean delivery is lower in pregnant women who undergo a web-based preparation for labor program, which is developed based on the health belief model and supported by motivational interviews. The frequency of episiotomy is lower in pregnant women who undergo a web-based preparation for labor program, which is developed based on a health belief model and supported by motivational interviews. Induction frequency is lower in pregnant women who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, than those who did not pass. Pregnants who underwent a web-based preparation program for labor, which was developed based on the health belief model and supported by motivational interviews, had a shorter delivery period than those who did not pass.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 31, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

March 31, 2021

Last Update Submit

April 2, 2021

Conditions

Keywords

motivational interviewingchildbirth trainingfear of childbirth,self-efficacyprimigravida women

Outcome Measures

Primary Outcomes (3)

  • has an effect on the fear of childbirth fear of birth birth self-efficacy

    Wijma Birth Expectation / Experience Scale Version A: It is a scale consisting of 33 items. The answers in the scale are numbered from 0 to 5, and are in six-point Likert type. Zero is expressed as "completely" and 5 as "nothing". While the minimum score on the scale is 0, the maximum score is 165. A high item total score indicates a high level of fear. Eighty-five and above points indicate clinical level fear.

    3 months

  • has an impact on birth self-efficacy

    Short Version of the Self-Efficacy Scale in Labor: Each sub-dimension of the scale consists of two sub-dimensions, and consists of 16 questions. The lowest score to be obtained from the scale sub-dimensions is 16 and the highest score is 160. The lowest total score that can be obtained from the scale is 32, and the total highest score is 320. High scores to be obtained from the scale indicate that pregnant women have high levels of self-efficacy in labor.

    3 months

  • has an effect on birth health belief

    Birth Health Belief Scale: The scale consists of 34 items and has five sub-dimensions. According to the subscales of the scale, the average "self-efficacy and motivation perception" is high 3.810 ± 1.409 (Min = 1; Max = 5), the average "benefit and motivation perception" is very high 4.368 ± 0.909 (Min = 1.75; Max = 5), "sensitivity perception of perception high 3,500 ± 1,502 (Min = 1; Max = 5), "caring / seriousness perception" average high 3,441 ± 1,600 (Min = 1; Max = 5), average "obstacle perception" 3,071 ± 1,508 (Min = 1; Max = 5).

    3 months

Study Arms (2)

Web-based birth preparation program supported by motivational interview

EXPERIMENTAL

A web-based childbirth preparation program prepared based on the Health Belief Model and supported by motivational interviews will be applied to primigravida women in the initiative group.

Other: Web-based childbirth preparation program developed based on health belief model and supported by motivational interview

web-based birth preparation program

EXPERIMENTAL

A web-based birth preparation program based on the Health Belief Model will be applied to primigravida women in the control group.

Other: Web-based childbirth preparation program based on health belief model

Interventions

In the three-month study, primigravida women in the initiative group will be given a web-based childbirth preparation program, which is prepared based on the Health Belief Model and supported by motivational interviews. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth.

Web-based birth preparation program supported by motivational interview

In the three-month study, a web-based childbirth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth.

web-based birth preparation program

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18-35,
  • At least a primary school graduate,
  • According to the last menstrual period or the results of ultrasonography of pregnant women who do not know the last menstrual period, who are in the 28-30 weeks of pregnancy,
  • Primigravida,
  • Live single pregnancy,
  • Without any obstacle to give birth through normal vaginal way,
  • No specified cesarean indication or risk factors that would adversely affect normal delivery (Heart disease, placenta previa, oligohydramnios, preeclampsia, anhydramnios, diabetes, epilepsy),
  • Not pregnant as a result of infertility treatment,
  • The state anxiety scale average score is below 60,
  • Edinburgh Postpartum Depression Scale average score of 12 or below,
  • Residing within the provincial borders of Sivas,
  • Internet at home,
  • Able to use a computer or mobile phone,
  • They are pregnant women who agree to participate in the research.

You may not qualify if:

  • Participants in the birth preparation class

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet Üniversitesi

Sivas, 58100, Turkey (Türkiye)

Location

Related Publications (4)

  • Artieta-Pinedo I, Paz-Pascual C, Grandes G, Remiro-Fernandezdegamboa G, Odriozola-Hermosilla I, Bacigalupe A, Payo J. The benefits of antenatal education for the childbirth process in Spain. Nurs Res. 2010 May-Jun;59(3):194-202. doi: 10.1097/NNR.0b013e3181dbbb4e.

    PMID: 20421842BACKGROUND
  • Munkhondya BMJ, Munkhondya TE, Chirwa E, Wang H. Efficacy of companion-integrated childbirth preparation for childbirth fear, self-efficacy, and maternal support in primigravid women in Malawi. BMC Pregnancy Childbirth. 2020 Jan 21;20(1):48. doi: 10.1186/s12884-019-2717-5.

    PMID: 31964346BACKGROUND
  • Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth. J Midwifery Womens Health. 2014 Mar-Apr;59(2):192-7. doi: 10.1111/jmwh.12075. Epub 2013 Dec 10.

    PMID: 24325752BACKGROUND
  • Toohill J, Fenwick J, Gamble J, Creedy DK, Buist A, Turkstra E, Ryding EL. A randomized controlled trial of a psycho-education intervention by midwives in reducing childbirth fear in pregnant women. Birth. 2014 Dec;41(4):384-94. doi: 10.1111/birt.12136. Epub 2014 Oct 9.

    PMID: 25303111BACKGROUND

Study Officials

  • BİRNUR YEŞİLDAĞ ÇELİK, Lecturer

    SİVAS CUMHURİYET UNIVERSITY

    PRINCIPAL INVESTIGATOR
  • ZEHRA GÖLBAŞI, Prof. Dr

    LOKMAN HEKİM UNIVERSITY

    STUDY DIRECTOR

Central Study Contacts

BİRNUR YEŞİLDAĞ ÇELİK, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In the study, the single blinding method, in which the participants are blinded, will be used. A placebo-controlled approach will be used in the control group (website training group) so that the participants in the groups do not know which group they are in. In the research, the statistician who also evaluates the outputs and performs data analysis will be blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 6, 2021

Study Start

April 15, 2021

Primary Completion

June 15, 2021

Study Completion

July 30, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

All IPD collected will share

Shared Documents
STUDY PROTOCOL
Time Frame
starts 1 month after broadcast
Access Criteria
all people have access.

Locations