NCT07167030

Brief Summary

Current scientific literature on VR details primarily focuses on fear and anxiety during childbirth. Variables such as attachment, fear, and self-efficacy are often considered independently. Therefore, in addition to interventions focused on the prenatal period, a need arose for holistic audiovisual and technologically supported intervention models that simultaneously address multidimensional aspects of life, such as prenatal attachment, fear of childbirth, and perception of childbirth self-efficacy.

Trial Health

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Trial Health Score

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Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2025

Status
not yet recruiting

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 Progress45%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

September 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

September 3, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

Prenatal attachmentFear of ChildbirthBirth Self-EfficacyVirtual RealityDigital Storytelling

Outcome Measures

Primary Outcomes (3)

  • Prenatal Attachment Inventory

    The Prenatal Attachment Inventory (PAI) developed by Muller (1993) is used to assess the thoughts, feelings, and states experienced by women during pregnancy and to determine their attachment to their babies during the prenatal period (Muller, 1993). The Turkish validity and reliability study of the inventory, conducted by Yılmaz and Beji (2013), consists of 21 items. Each item is a four-point Likert-type scale, ranging from 1 to 4. A minimum score of 21 and a maximum score of 84 can be obtained from the scale. Increasing scores indicate increased attachment. The scale's validity and reliability performance was found to be 0.84, with a Cronbach's alpha of 0.10.

    Time Frame: Pre-test (before intervention) Time Frame: Post-test (after intervention: 36th week of pregnancy, after the fourth module)

  • Wijma Childbirth Expectation/Experience Questionnaire Version A (W-DEQ-A)

    Developed by Wijma et al. (1998) to assess the level of fear of childbirth experienced by pregnant women, the scale was adapted into Turkish by Körükcü (2009). Version A of the W-DEQ is a 33-item scale. Responses are numbered from 0 to 5 and are on a six-point Likert-type scale. The minimum score is 0, and the maximum score is 165. A high total score indicates a high level of fear. In the validity and reliability study of the scale, Cronbach's Alpha was found to be 0.89 (Körükcü, 2009).

    Time Frame: Pre-test (before intervention) Time Frame: Post-test (after intervention: 36th week of pregnancy, after the fourth module)

  • Short Version of the Labor Self-Efficacy Scale

    The Turkish adaptation of the scale, developed to measure women's self-efficacy for childbirth, was conducted by Ersoy (2011). The scale consists of two sub-dimensions: competence and outcome expectation, and a total of 32 questions. Scores for each sub-dimension range from 16 to 160. As the score on each sub-dimension increases, the competence and outcome expectation for childbirth increases. The Likert-type scale is scored from 1 to 10. In the outcome expectation sub-dimension of the scale, 1 represents "not at all useful," and 10 represents "very useful." In the competence expectation sub-dimension, questions 1 to 13 are scored as 1 "completely confident," 10 represents "not at all confident," and the remaining questions are scored as 1 "not at all confident," and 10 represents "completely confident." The first 13 questions in the competence expectation sub-dimension of the scale are reverse-scored. The total score obtained from the scale ranges from 32 to 320. As the score on the

    Time Frame: Pre-test (before intervention) Time Frame: Post-test (after intervention: 36th week of pregnancy, after the fourth module)

Secondary Outcomes (1)

  • NST Follow-up Form

    Time Frame: 34th weeks of pregnancy (during the last two modules) Time Frame: 36th weeks of pregnancy (during the last two modules)

Other Outcomes (2)

  • Video Immersion Scale (VIS)

    Time Frame: Post-intervention (post-intervention: 36th week of pregnancy, after the fourth module)

  • Virtual Reality Glasses Application Satisfaction Level Information Form

    Time Frame: Post-intervention (post-intervention: 36th week of pregnancy, after the fourth module)

Study Arms (2)

İntervention Arm

EXPERIMENTAL

Participants in the intervention group will receive digital storytelling modules using virtual reality (VR) headsets once a week for four weeks, starting at 28 weeks of gestation. Each module will include three topics (2-10 minutes). After each topic, there will be a rest period followed by an interactive session. The final two modules will be administered during the NST recording, and mother and baby status will be monitored. Each module, including the interactive session, will last 45-50 minutes. Participants will receive an educational brochure after the module and will be reminded via WhatsApp. Posttests (at the end of 36 weeks of gestation): * Prenatal Attachment Inventory * Wijma Birth Expectations/Experiences Questionnaire Version A * Short Version of the Labor Self-Efficacy Scale * Satisfaction Level Information Form for the VR Headset Application * NST Follow-up Form * Video Immersion Scale

Behavioral: Virtual Reality Digital Storytelling

Control Arm

NO INTERVENTION

Participants in the control group will receive routine care. Posttests (at the end of 36 weeks of gestation): * Prenatal Attachment Inventory * Wijma Birth Expectations/Experiences Questionnaire Version A * Short Version of the Labor Self-Efficacy Scale * NST Follow-up Form

Interventions

Participants in the intervention group will receive digital storytelling modules using virtual reality (VR) headsets once a week for four weeks, starting at 28 weeks of gestation. Each module will include three topics (2-10 minutes). After each topic, there will be a rest period followed by an interactive session. The final two modules will be administered during the NST recording, and mother and baby status will be monitored. Each module, including the interactive session, will last 45-50 minutes. Participants will receive an educational brochure after the module and will be reminded via WhatsApp.

İntervention Arm

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who are biologically female and experiencing their first reproduction are eligible to participate.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous women in their 28th week of pregnancy
  • Between the ages of 18 and 40
  • Experiencing a singleton pregnancy
  • Applied to the Yozgat City Hospital Gynecology and Obstetrics Clinic and agreed to participate in the study
  • Have a primary school education and can understand Turkish
  • Have no serious vision or balance problems that would prevent the use of VR glasses
  • Have not experienced any risky pregnancy problems (premature membrane rupture, preeclampsia, gestational diabetes, etc.)
  • Have no identified fetal anomalies
  • Have no psychiatric diagnosis

You may not qualify if:

  • Pregnant women who cannot obtain a work permit and who do not agree to participate in the study will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

RUKİYE DİKMEN, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
There is no other hidden side to this study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Arm 1 Intervention Arm: Participants in the intervention group will receive digital storytelling modules using virtual reality (VR) headsets once a week for four weeks, starting at 28 weeks of gestation. Each module will include three topics (2-10 minutes). After each topic, there will be a rest period followed by an interactive session. The final two modules will be administered during the NST recording, and mother and baby status will be monitored. Each module, including the interactive session, will last 45-50 minutes. Participants will receive an educational brochure after the module and will be reminded via WhatsApp. Arm 2 Control Arm: Participants in the control group will receive routine care. Posttests (at the end of 36 weeks of gestation): * Prenatal Attachment Inventory * Wijma Birth Expectations/Experiences Questionnaire Version A * Short Version of the Labor Self-Efficacy Scale * Satisfaction Level Information Form for the VR Headset Application * NST Follow-up Form * Video
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 11, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant confidentiality and as data was collected only for this study.