NCT06196151

Brief Summary

Today, pregnancy and childbirth are important life events that involve many challenges and changes for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often lead to anxiety about the health of the baby and her own health and to the creation of new stressful situations. During antenatal education, deep relaxation and breathing techniques taught to pregnant women during labour and delivery allow the mother to relax and cope with birth pains more easily and on her own. There are not enough studies in the literature to evaluate the effectiveness of online antenatal classes. In cases where face-to-face antenatal education is not possible during pregnancy, online education is an important option. In the literature, there is no study evaluating how antenatal education affects women's fear of childbirth, physiological ability to give birth and traumatic birth perception together. Therefore, the aim of this study is to examine the effect of antenatal education on fear of childbirth, physiological ability to give birth and perception of traumatic birth. The type of the study is a randomised controlled experimental study with pre-post and control group. The research will be conducted in the form of online training meetings on pregnant women reached through social media. The population of the study will consist of healthy pregnant women who apply to the researchers as a result of the announcements made through social media and who are at the 20th gestational week at the earliest. The sample size was determined by t-test analysis in independent groups in G\*power statistical programme, based on two variables, 0.05 significance level, 80% power and medium effect (0.50). Accordingly, a total of 42 pregnant women, 21 pregnant women in each group, are planned to be included in the study. Intention-to-treat analysis will be performed to prevent bias and losses. As an intervention programme, a total of three weeks and six hours of childbirth preparation training will be given, two hours each week. The programme has been prepared by faculty members who have conducted childbirth preparation classes, based on the literature and by making use of childbirth preparation philosophies and methods.

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
42

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable healthy-volunteers

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

January 25, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

14 days

First QC Date

December 18, 2023

Last Update Submit

January 8, 2024

Conditions

Keywords

Antenatal EducationFear of BirthPhysiological Ability to Give BirthTraumatic Birth Perception

Outcome Measures

Primary Outcomes (4)

  • Introductory Information Form

    This form, which was developed in line with the literature, consists of 9 questions to obtain some socio-demographic characteristics and obstetric information of pregnant women.

    Baseline (It will be applied before starting the intervention)

  • Preparation for Labor and Birth (P-LAB) Instrument

    The Preparation for Labor and Birth (P-LAB) Instrument was developed by Neerland and colleagues (Neerland et al., 2020). It was conducted to determine the confidence of pregnant women in their physiological ability to give birth. The scale is 5-point Likert type and consists of 22 items. The scale consists of four sub-dimensions. The Turkish validity and reliability study of the scale was conducted by Uludağ and Uçtu (2022). Cronbach's alpha value is above 0.70 for all scales and subscales.

    Baseline (It will be applied before starting the intervention)

  • Traumatic Birth Perception Scale

    The scale developed by Yalnız et al. (2016) to measure the perception of traumatic birth in women (18-40 years old) consists of 13 questions and one sub-dimension. The cronbach alpha value of the scale was found to be 0.89. Each question is scored between 0-10 from none to the most severe. As the score obtained from the scale increases, the level of perception of birth as traumatic increases.

    Baseline (It will be applied before starting the intervention)

  • Fear of Childbirth Scale for Pregnant Women and Their Partners

    The Fear of Birth Scale (FOBS) was developed by Haines et al. in 2011 to measure fear of childbirth. Psychometric analyses in Turkish culture were conducted by Serçekuş Ak, Vardar, \& Özkan (2018) and it was determined that the scale is a valid and reliable measurement tool that can be used to determine fear of childbirth on pregnant women and their partners in Turkish society. In the Turkish validity and reliability study of the scale, the cronbach alpha internal consistency coefficient was found to be 0.93.

    Baseline (It will be applied before starting the intervention)

Secondary Outcomes (3)

  • Preparation for Labor and Birth (P-LAB) Instrument

    through study completion, an average of one week.

  • Traumatic Birth Perception Scale

    through study completion, an average of one week.

  • Fear of Childbirth Scale for Pregnant Women and Their Partners

    through study completion, an average of one week.

Study Arms (2)

Experimental

EXPERIMENTAL
Behavioral: Antenatal training

No intervention

NO INTERVENTION

Interventions

Training hours: Training will be completed in a total of three weeks and six hours, two hours each week. Method: The training will be given online via Zoom application. The training will consist of a total of three weeks and six hours, two hours each week. "Informed Voluntary Consent Form" will be obtained from individuals in both groups. Pregnant women in both the control and intervention groups will be asked to fill out the "Women's Introductory Information Form". The data of the intervention group will be filled out before the first Antenatal education lesson and after all six-hour Antenatal education lessons are completed. The data of the control group will be filled in parallel with the intervention group. Group to receive the training: Healthy pregnant women who are at the 20th gestational week at the earliest will be included in the training. Trainings will be carried out in closed groups.

Experimental

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBeing over 18 years of age Being at the 20th gestational week at the earliest
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary acceptance to participate in the research
  • Being over 18 years of age
  • Being at the 20th gestational week at the earliest.
  • Not carrying a high risk in pregnancy
  • Nulliparity
  • Expected to have a normal spontaneous labour

You may not qualify if:

  • Refusal to participate in the research
  • Failure to complete six hours of the childbirth preparation class
  • Inability to use the Zoom application
  • Psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University Faculty of Health Sciences

Denizli, Kınıklı, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Sinem Göral Türkcü, Phd, RN, Assist Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 9, 2024

Study Start

January 25, 2024

Primary Completion

February 8, 2024

Study Completion

February 29, 2024

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations