NCT07496879

Brief Summary

Childbirth is a unique experience that affects maternal health physiologically, emotionally, and socially, and represents a crucial step in the transition to motherhood. Primiparous women often experience fear related to childbirth due to uncertainty about the process, pain, or possible complications. This randomized controlled trial aims to evaluate the effect of a QR code-based virtual tour of the delivery room on primiparous women's fear of childbirth, childbirth readiness, vaginal birth rate, and postpartum breastfeeding self-efficacy. Participants will be provided access to three virtual videos via QR codes, allowing them to explore the delivery room, understand the admission process, and learn about postpartum care. The study will assess outcomes using validated scales for childbirth fear, prenatal readiness, birth-related self-efficacy, and postpartum breastfeeding. By familiarizing participants with the delivery environment, this intervention aims to reduce fear, improve confidence and preparedness, and encourage vaginal delivery. The findings are expected to inform strategies to enhance maternal experiences, support national initiatives such as the Normal Birth Action Plan, and contribute to safer, more satisfying birth and breastfeeding outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 11, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

Childbirth anxietyBirth preparednessLabor self-efficacyPostpartum breastfeedingVirtual tourQR code educationPrimigravida

Outcome Measures

Primary Outcomes (4)

  • Wijma Birth Expectation/Experience Scale (W-Deq) Version A

    The scale was developed by Wijma et al. (1998) to determine fear of childbirth. The validity and reliability study of the scale in Turkish was conducted by Körükçü et al. (2012). It is a 33-item scale with specific cutoff points: low degree of fear of childbirth (≤37), moderate degree of fear of childbirth (38-65), severe degree of fear of childbirth (66-84), and clinical degree of fear of childbirth (≥85).

    It will be administered as a pre-test between the 28th and 32nd weeks of pregnancy, and as a post-test between the 38th and 40th weeks of pregnancy.

  • Prenatal Self-Assessment Scale-Readiness for Childbirth Subscale (PSAS-DHO)

    The Turkish adaptation of the scale developed by Lederman and Lederman (1979) to assess the adjustment of pregnant women to pregnancy and motherhood was made by Beydağ and Mete (2008). The scale, consisting of 79 items and 7 sub-dimensions, is a 4-point Likert scale (4: describes too much, 3: partially describes, 2: describes somewhat, 1: does not describe at all). The sub-dimensions of the scale are: readiness for childbirth, acceptance of pregnancy, fear of childbirth, acceptance of the maternal role, thoughts about the health of oneself and one's baby, the state of one's relationship with one's own mother, and the state of one's relationship with one's spouse. In this study, the readiness for childbirth sub-dimension will be used. The lowest possible score for the readiness for childbirth sub-dimension is 10, and the highest is 40. A lower score indicates higher adjustment.

    It will be administered as a pre-test between the 28th and 32nd weeks of pregnancy, and as a post-test between the 38th and 40th weeks of pregnancy.

  • Self-Efficacy Scale for Normal Delivery

    Developed by Kahraman (2020), this is a visual analog scale consisting of 9 questions. To better understand participants' self-efficacy and self-confidence before birth, and to obtain a kind of birth self-efficacy coefficient, the 9 items were transferred to an 11-point visual scale from 0 to 10. The scoring is as follows: "0 points = lack of self-confidence, 10 points = very confident in myself". As the scores obtained from the self-efficacy scale increase, the degree of self-efficacy also increases.

    It will be administered as a pre-test between the 28th and 32nd weeks of pregnancy, and as a post-test between the 38th and 40th weeks of pregnancy.

  • Birth Beliefs Scale (BBS)

    Developed by Preis and Benyamini (2017) to assess women's core beliefs about childbirth, this scale was adapted into Turkish by Paker and Ertem (2022). Consisting of 11 items, this scale uses a five-point Likert scale. It comprises two sub-dimensions: beliefs that perceive childbirth as a natural process and beliefs that view childbirth as a medical process. Scores ranging from 5 to 25 are obtained for the sub-dimension of beliefs regarding the natural process, and scores ranging from 6 to 30 are obtained for the sub-dimension of beliefs regarding the medical process. Scoring is done by dividing the total score of all items belonging to the relevant sub-dimension by the number of items to calculate the arithmetic mean. The sub-dimension with a higher arithmetic mean reflects the dominant belief style of the woman regarding childbirth.

    It will be administered as a pre-test between the 28th and 32nd weeks of pregnancy, and as a post-test between the 38th and 40th weeks of pregnancy.

Secondary Outcomes (3)

  • Vaginal Birth Rate

    Within the first 10 days after delivery.

  • Breastfeeding Self-Efficacy Scale (BSES)-Short Form

    On the first 10 days postpartum

  • Birth Satisfaction Scale Revised (BSS-R) Form

    On the first 10 days postpartum

Study Arms (2)

Intervention Group - QR Code Virtual Delivery Room Tour

EXPERIMENTAL

Participants will watch three short videos via QR codes covering admission, labor room tour, and postpartum care to reduce childbirth fear and increase birth readiness.

Behavioral: Virtual Delivery Room Tour via QR Codes

Control Group - Standard Prenatal Care

NO INTERVENTION

Participants will receive standard prenatal care without the virtual tour videos.

Interventions

Three short videos via QR codes on admission, labor room, and postpartum care.

Intervention Group - QR Code Virtual Delivery Room Tour

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be biologically female and pregnant (primigravida women).
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being literate
  • Being 18 years of age or older
  • Being primigravida
  • Being between 28-32 weeks of gestation
  • Owning a smartphone
  • Having internet access
  • Being able to speak and understand Turkish

You may not qualify if:

  • Multiparity
  • High-risk pregnancy
  • Having a diagnosed psychiatric disorder
  • Failure to complete the questionnaires during the study period Preterm birth or pregnancy loss before completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University - Faculty of Health Sciences, Department of Midwifery

Erzurum, Yakutiye, 25030, Turkey (Türkiye)

Location

Study Officials

  • AYLA KANBUR, PROF. DR.

    Atatürk University - Faculty of Health Sciences, Department of Midwifery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Participants and study staff are aware of group assignments. The intervention group receives a QR code-based virtual tour of the delivery room, while the control group receives standard care. Outcome assessments are based on self-reported questionnaires completed by participants, and no blinding is applied.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This randomized controlled trial evaluates the effect of a QR code-based virtual delivery room tour on primigravida women's fear of childbirth, delivery readiness, vaginal birth self-efficacy, and postpartum breastfeeding confidence. Conducted at Erzurum City Hospital, participants aged 18-45 weeks 28-32 gestation, literate, and with smartphone access will be randomized into intervention and control groups. The intervention group watches three short videos via QR codes covering admission, labor, and postpartum care. Primary outcomes include fear of childbirth, readiness for delivery, and birth self-efficacy; secondary outcomes include breastfeeding self-efficacy and birth satisfaction. The study aims to reduce childbirth fear, improve vaginal birth rates, and enhance maternal confidence and satisfaction.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD Student

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 27, 2026

Study Start

January 1, 2026

Primary Completion

March 31, 2026

Study Completion

May 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared due to privacy and ethical considerations. Data may be available from the principal investigator upon reasonable request and with appropriate ethical approval.

Locations