Primiparous Pregnant WomenNCT07167030
Virtual Reality-Enabled Digital Storytelling
A study testing Virtual Reality Digital Storytelling in people with Primiparous Pregnant Women, run by Bozok University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primiparous Pregnant Women
- What is being tested?
- Virtual Reality Digital Storytelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Have not experienced any risky pregnancy problems (premature membrane rupture, preeclampsia, gestational diabetes, etc.)
- Have no identified fetal anomalies
- Have no psychiatric diagnosis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yozgat Şehir Hastanesi
Yozgat, Yozgat, 66100
RUKİYE DİKMEN, 05433686510, rukiye.dikmen@yobu.edu.tr
About this study
Official title: Evaluation of the Effects of Digital Storytelling Applied to Primiparous Pregnant Women With Virtual Reality Glasses on Prenatal Attachment, Fear of Childbirth, Perception of Childbirth Self-Efficacy, and Non-Stress Test Results
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.
Read the detailed description
This study is a randomized controlled trial conducted to evaluate the effects of digital storytelling applied to primiparous pregnant women via virtual reality glasses on prenatal attachment, fear of childbirth, perception of childbirth self-efficacy, and non-stress test results. The study will consist of two groups: an experimental and a control group. Participants in the experimental group will access a digital storytelling training program via virtual reality glasses and receive information and guidance on topics such as prenatal attachment, fear of childbirth, and perception of childbirth self-efficacy. Participants in the control group will receive standard care.
- Conditions
- Primiparous Pregnant Women
- Being tested
- Virtual Reality Digital Storytelling
- Keywords
- Prenatal attachment, Fear of Childbirth, Birth Self-Efficacy, Virtual Reality, Digital Storytelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Digital StorytellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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
This form consists of sections containing the emotional state and NST findings experienced by pregnant women during the NST procedure. The NST results in the NST Follow-up Form will be evaluated and recorded by the researcher.
Measured: Time Frame: 34th weeks of pregnancy (during the last two modules) Time Frame: 36th weeks of pregnancy (during the last two modules)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primiparous Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUKİYE DİKMEN, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167030
- Sponsor's protocol ID
- 1231
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and as data was collected only for this study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Digital Storytelling Applied to Primiparous Pregnant Women With Virtual Reality Glasses on Prenatal Attachment, Fear of Childbirth, Perception of Childbirth Self-Efficacy, and Non-Stress Test Results
- ClinicalTrials.gov ID
- NCT07167030
- Acronym / sponsor ID
- 1231
- Conditions
- Primiparous Pregnant Women
- Keywords
- Prenatal attachment, Fear of Childbirth, Birth Self-Efficacy, Virtual Reality, Digital Storytelling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized controlled trial conducted to evaluate the effects of digital storytelling applied to primiparous pregnant women via virtual reality glasses on prenatal attachment, fear of childbirth, perception of childbirth self-efficacy, and non-stress test results. The study will consist of two groups: an experimental and a control group. Participants in the experimental group will access a digital storytelling training program via virtual reality glasses and receive information and guidance on topics such as prenatal attachment, fear of childbirth, and perception of childbirth self-efficacy. Participants in the control group will receive standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| İntervention Arm | Experimental | Behavioral: Virtual Reality Digital StorytellingParticipants 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 |
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Digital StorytellingParticipants 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. | Behavioural | İntervention Arm |
Primary outcome
Prenatal Attachment Inventory
Time frame: Time Frame: Pre-test (before intervention) Time Frame: Post-test (after intervention: 36th week of pregnancy, after the fourth module)
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.
Wijma Childbirth Expectation/Experience Questionnaire Version A (W-DEQ-A)
Time frame: Time Frame: Pre-test (before intervention) Time Frame: Post-test (after intervention: 36th week of pregnancy, after the fourth module)
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).
Short Version of the Labor Self-Efficacy Scale
Time frame: Time Frame: Pre-test (before intervention) Time Frame: Post-test (after intervention: 36th week of pregnancy, after the fourth module)
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
1 secondary outcome
NST Follow-up Form
Time frame: Time Frame: 34th weeks of pregnancy (during the last two modules) Time Frame: 36th weeks of pregnancy (during the last two modules)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and as data was collected only for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Digital Storytelling in people with Primiparous Pregnant Women, run by Bozok University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RUKİYE DİKMEN, PhD Student (+905433686510, rukiye.dikmen@yobu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal Attachment Inventory (time frame: Time Frame: Pre-test (before intervention) Time Frame: Post-test (after intervention: 36th week of pregnancy, after the fourth module)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.