- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07496879
QR-Based Virtual Tour and Childbirth Outcomes (VIRTU-BIRTH)
The Effect of a QR Code-Based Virtual Tour of the Delivery Room on Fear of Childbirth, Childbirth Readiness, Vaginal Birth Rate, and Postpartum Breastfeeding Self-Efficacy in Primiparous Women: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Childbirth is a unique experience that affects maternal health physiologically, emotionally, and socially, serving as a significant step in the transition to motherhood. Primiparous women, in particular, often experience fear during pregnancy due to both their anticipation of holding their baby and concerns about the challenges and difficulties they may face during labor. Studies show that fear of childbirth is higher in primiparous women compared to multiparous women and can cause emotional and psychological distress in daily life.
The main causes of fear of childbirth include lack of knowledge about the labor process, inability to tolerate pain, panic, lack of trust in healthcare providers, doubt in vaginal delivery, fear of interventions such as episiotomy or laceration, and concerns about the health of the baby or mother. Additionally, negative birth stories shared in social environments can increase anxiety.
Research indicates that preparation for childbirth can reduce fear and increase active participation in the labor process. When women feel psychologically and physiologically prepared, they are more likely to have a positive birth experience. Furthermore, childbirth self-efficacy-confidence in the ability to cope with labor pain and achieve vaginal birth-is directly associated with birth outcomes. Higher self-efficacy increases perceived control, reduces the need for surgical interventions, and improves postpartum satisfaction.
This study aims to evaluate the effect of a QR code-based virtual tour of the delivery room on childbirth fear, birth readiness, vaginal birth rates, and postpartum breastfeeding self-efficacy in primiparous women. Participants between 28 and 40 weeks of gestation will be provided with a three-step virtual tour: (1) Admission and Interventions in the Delivery Room, (2) Virtual Visit of the Labor and TDL Rooms, and (3) Postpartum Care and Breastfeeding Education. Access to the videos will be provided through separate QR codes for each session.
The study will employ a randomized controlled design. The intervention group will watch the QR code-based videos, and pre-test and post-test measurements will be conducted. The control group will not receive any intervention, and parallel measurements will be taken. Measurement tools include the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) Version A, Prenatal Self-Assessment Scale - Birth Readiness Subscale, Self-Efficacy for Normal Birth Scale, Birth Beliefs Scale (BBS), Breastfeeding Self-Efficacy Scale (BSES), and Revised Birth Satisfaction Scale (BSS-R).
It is expected that the intervention will reduce fear of childbirth, improve birth readiness and self-efficacy, increase vaginal birth rates, and enhance postpartum breastfeeding satisfaction among primiparous women. Additionally, the study aims to provide an innovative and sustainable model that can contribute to the effectiveness of national initiatives such as Normal Birth Action Plans, Midwifery Clinics, and Antenatal Classes.
The study population consists of primigravida women aged 18-45 attending the Midwifery Clinic at Erzurum City Hospital. The sample size was determined as 100 participants using a priori power analysis and randomly assigned to the intervention and control groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yakutiye
-
Erzurum, Yakutiye, Turkey (Türkiye), 25030
- Atatürk University - Faculty of Health Sciences, Department of Midwifery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group - QR Code Virtual Delivery Room Tour
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.
|
Three short videos via QR codes on admission, labor room, and postpartum care.
|
|
No Intervention: Control Group - Standard Prenatal Care
Participants will receive standard prenatal care without the virtual tour videos.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wijma Birth Expectation/Experience Scale (W-Deq) Version A
Time Frame: 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.
|
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)
Time Frame: 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.
|
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
Time Frame: 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.
|
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)
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaginal Birth Rate
Time Frame: Within the first 10 days after delivery.
|
Primiparous women who participated in the study and provided their phone numbers will be contacted within the first 10 days postpartum and asked about the mode of delivery (normal [vaginal] delivery and/or cesarean section).
|
Within the first 10 days after delivery.
|
|
Breastfeeding Self-Efficacy Scale (BSES)-Short Form
Time Frame: On the first 10 days postpartum
|
The scale was developed by Dennis and Faux (1999) to determine mothers' breastfeeding self-efficacy levels, and the initial form consisted of 33 items.
Later, Dennis (2003) removed some items and created a new 14-item "short form of the breastfeeding self-efficacy scale".
The Turkish validity and reliability study of the scale was conducted by Aluş Tokat et al. (2010).
The scale is suitable for use during pregnancy and the postpartum period.
The scale is a 5-point Likert scale ranging from "I'm not sure at all" (1 point) to "I'm always sure" (5 points).
The lowest possible score is 14, and the highest is 70.
Since there is no cutoff point, a higher score indicates higher breastfeeding self-efficacy.
|
On the first 10 days postpartum
|
|
Birth Satisfaction Scale Revised (BSS-R) Form
Time Frame: On the first 10 days postpartum
|
The Turkish validity and reliability study of the scale developed by Hollins-Martin and Martin (2014) was conducted by Gökmen (2017).
The WMO-R is a 10-item, 3-subdimension measurement tool administered to women who have had a normal delivery, within the first ten days postpartum.
The names of the sub-dimensions of the WMO-R are "quality of care," "stress experienced during labor," and "woman's personal characteristics."
The scale uses a 5-point Likert type.
Strongly disagree is scored as "0 points," disagree as "1 point," undecided as "2 points," agree as "3 points," and strongly agree as "4 points."
Scores range from 0 to 40.
A higher score indicates increased birth satisfaction for the woman.
|
On the first 10 days postpartum
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: AYLA KANBUR, PROF. DR., Atatürk University - Faculty of Health Sciences, Department of Midwifery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B.30.2.ATA.0.01.00/576-1
- Ataturk University BAP Project (Other Identifier: Ataturk University BAP Project No: TDK-2025-16182)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fear of Childbirth
-
Mehmet Akif Ersoy UniversityNot yet recruitingFear of Childbirth | Childbirth Education
-
Near East University, TurkeyCompletedFear of Childbirth | Childbirth ExperienceCyprus
-
Kocaeli UniversityLokman Hekim ÜniversitesiNot yet recruitingFear of Childbirth | Childbirth Self EfficacyTurkey
-
Lokman Hekim ÜniversitesiCompletedFear of Childbirth | Mode of Delivery | Childbirth Self-Efficacy | Childbirth Preparation ProgramTurkey (Türkiye)
-
Kutahya Health Sciences UniversityCompletedFear of Childbirth | Beliefs About Childbirth | Mode of Birth | Childbirth Preparation ClassesTurkey (Türkiye)
-
Cardenal Herrera UniversityRecruiting
-
Ege UniversityCompletedFear of ChildbirthTurkey (Türkiye)
-
Helsinki University Central HospitalUnknownFear of ChildbirthFinland
-
University of Las Palmas de Gran CanariaServicio Canario de SaludCompleted
-
Marmara UniversityCompleted
Clinical Trials on Virtual Delivery Room Tour via QR Codes
-
Samsung Medical CenterNot yet recruiting
-
Karabuk UniversityCompletedPregnancy | Virtual Reality | Midwifery | Adaptation | Birth | Delivery RoomTurkey