ChildbirthFITVRDLNCT07793136
Fetal Images Through Virtual Reality During Labor
A study testing Virtual Reality in people with Childbirth, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This randomized controlled trial aims to evaluate the effect of viewing personalized fetal images through a virtual reality (VR) headset during labor on childbirth comfort, maternal attachment, and perceived traumatic childbirth. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 18 years or older
- Primiparous women
- Gestational age of 28-32 weeks at the time of eligibility assessment
- Singleton pregnancy
- Able to communicate in Turkish
- Willing to participate in the study
- Able to provide written informed consent for study participation and recording of personalized fetal ultrasound images.
Who cannot join
- Indication for elective cesarean delivery
- Visual or hearing impairment that could interfere with the intervention
- Maternal or fetal medical complications
- Pregnancy conceived through assisted reproductive techniques
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Viewing Personalized Fetal Images Through Virtual Reality During Labor on Childbirth Comfort, Maternal Attachment, and Perceived Traumatic Childbirth: A Randomized Controlled Trial
Aim: This randomized controlled trial aims to evaluate the effect of viewing personalized fetal images through a virtual reality (VR) headset during labor on childbirth comfort, maternal attachment, and perceived traumatic childbirth.
Methods: The study will include primiparous pregnant women at 28-32 weeks of gestation who voluntarily agree to participate and provide consent for fetal image recording. Participants will be randomly assigned to an intervention group or a control group. During labor, women in the intervention group will view their own personalized fetal images accompanied by fetal heart sounds through a VR headset for at least four minutes, with the option to continue viewing if desired. The control group will receive routine intrapartum care. Data will be collected using the Pregnant Woman Descriptive Information Form, Childbirth Comfort Questionnaire, Maternal Attachment Scale, and Traumatic Childbirth Perception Scale. Data will be analyzed using appropriate statistical methods, including independent-samples t-test, paired-samples t-test, and chi-square test, as appropriate. Statistical significance will be set at p < 0.05.
Read the detailed description
Aim:
This randomized controlled trial aims to evaluate the effect of viewing personalized fetal images through a virtual reality (VR) headset during labor on childbirth comfort, maternal attachment, and perceived traumatic childbirth.
Study Design and Participants:
The study will be conducted among primiparous pregnant women at 28-32 weeks of gestation who voluntarily agree to participate and provide informed consent for fetal image recording. Eligible participants will be randomly assigned to an intervention group or a control group.
Intervention:
During labor, participants assigned to the intervention group will view personalized images of their own fetus through a VR headset. The fetal images will be accompanied by fetal heart sounds. The VR intervention will be administered for a minimum of four minutes, and participants will have the option to continue viewing the personalized fetal images if they wish.
Control:
Participants assigned to the control group will receive routine intrapartum care without exposure to personalized fetal images through a VR headset.
Outcome Measures:
The primary outcomes will include childbirth comfort, maternal attachment, and perceived traumatic childbirth. Data will be collected using the Pregnant Woman Descriptive Information Form, Childbirth Comfort Questionnaire, Maternal Attachment Scale, and Traumatic Childbirth Perception Scale.
Statistical Analysis:
Data will be analyzed using appropriate statistical methods according to the distribution and characteristics of the variables. Independent-samples t-test, paired-samples t-test, and chi-square test may be used as appropriate. Statistical significance will be set at p < 0.05.
Ethical Considerations:
The study will be conducted in accordance with ethical principles and after obtaining approval from the relevant ethics committee. Written informed consent will be obtained from all participants before participation in the study.
- Conditions
- Childbirth
- Being tested
- Virtual Reality
- Keywords
- Childbirth comfort; maternal attachment; perceived traumatic birth; virtual reality; labor;, childbirth comfort, maternal attachment, perceived traumatic birth, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Also called Fetal Images Through Virtual Reality
Participants in the intervention group will view personalized fetal ultrasound images recorded during routine antenatal ultrasonography using a virtual reality headset during the first stage of labor. The fetal ultrasound images will be accompanied by fetal heart sounds. The intervention will be administered when cervical dilatation reaches 4-9 cm in a quiet environment. Each viewing session will last for at least 4 minutes, and participants will be allowed to continue viewing according to their preference. The duration of VR exposure will be recorded for each participant.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Fetal Images Through Virtual Reality | Experimental | Participants in this arm will view personalized fetal ultrasound images accompanied by fetal heart sounds using a virtual reality headset during the first stage of labor. Receives: Behavioral: Virtual Reality |
| Routine Intrapartum Care | No intervention | Participants in this group received routine intrapartum care according to the hospital protocol. No additional intervention was provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Attachment
Maternal attachment will be assessed using the Maternal Attachment Scale. Higher scores indicate stronger maternal attachment.
Measured: 30 days postpartum.
Childbirth Comfort
Childbirth comfort will be assessed using the Childbirth Comfort Questionnaire (CCQ), a 9-item, 5-point Likert-type scale consisting of physical, psychospiritual, and environmental comfort subscales. Total scores range from 9 to 45, with higher scores indicating greater childbirth comfort.
Measured: During active labor, at 8 cm cervical dilatation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start30 Jan 2026
- Primary completion15 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildbirthStudies 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
- This study used a randomized controlled intervention model. Participants were randomly assigned to an intervention or control group. The intervention group viewed personalized fetal images accompanied by fetal heart sounds through a virtual reality headset during labor, while the control group received routine intrapartum care.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Akın, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793136
- Sponsor's protocol ID
- 2024/623
- Acronym
- FITVRDL
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Viewing Personalized Fetal Images Through Virtual Reality During Labor on Childbirth Comfort, Maternal Attachment, and Perceived Traumatic Childbirth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07793136
- Acronym / sponsor ID
- FITVRDL / 2024/623
- Conditions
- Childbirth
- Keywords
- Childbirth comfort; maternal attachment; perceived traumatic birth; virtual reality; labor;, childbirth comfort, maternal attachment, perceived traumatic birth, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 28 Aug 2026 (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.
Aim: This randomized controlled trial aims to evaluate the effect of viewing personalized fetal images through a virtual reality (VR) headset during labor on childbirth comfort, maternal attachment, and perceived traumatic childbirth.
Methods: The study will include primiparous pregnant women at 28-32 weeks of gestation who voluntarily agree to participate and provide consent for fetal image recording. Participants will be randomly assigned to an intervention group or a control group. During labor, women in the intervention group will view their own personalized fetal images accompanied by fetal heart sounds through a VR headset for at least four minutes, with the option to continue viewing if desired. The control group will receive routine intrapartum care. Data will be collected using the Pregnant Woman Descriptive Information Form, Childbirth Comfort Questionnaire, Maternal Attachment Scale, and Traumatic Childbirth Perception Scale. Data will be analyzed using appropriate statistical methods, including independent-samples t-test, paired-samples t-test, and chi-square test, as appropriate. Statistical significance will be set at p < 0.05.
Detailed description
Aim:
This randomized controlled trial aims to evaluate the effect of viewing personalized fetal images through a virtual reality (VR) headset during labor on childbirth comfort, maternal attachment, and perceived traumatic childbirth.
Study Design and Participants:
The study will be conducted among primiparous pregnant women at 28-32 weeks of gestation who voluntarily agree to participate and provide informed consent for fetal image recording. Eligible participants will be randomly assigned to an intervention group or a control group.
Intervention:
During labor, participants assigned to the intervention group will view personalized images of their own fetus through a VR headset. The fetal images will be accompanied by fetal heart sounds. The VR intervention will be administered for a minimum of four minutes, and participants will have the option to continue viewing the personalized fetal images if they wish.
Control:
Participants assigned to the control group will receive routine intrapartum care without exposure to personalized fetal images through a VR headset.
Outcome Measures:
The primary outcomes will include childbirth comfort, maternal attachment, and perceived traumatic childbirth. Data will be collected using the Pregnant Woman Descriptive Information Form, Childbirth Comfort Questionnaire, Maternal Attachment Scale, and Traumatic Childbirth Perception Scale.
Statistical Analysis:
Data will be analyzed using appropriate statistical methods according to the distribution and characteristics of the variables. Independent-samples t-test, paired-samples t-test, and chi-square test may be used as appropriate. Statistical significance will be set at p < 0.05.
Ethical Considerations:
The study will be conducted in accordance with ethical principles and after obtaining approval from the relevant ethics committee. Written informed consent will be obtained from all participants before participation in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a randomized controlled intervention model. Participants were randomly assigned to an intervention or control group. The intervention group viewed personalized fetal images accompanied by fetal heart sounds through a virtual reality headset during labor, while the control group received routine intrapartum care.
| Arm | Type | Receives |
|---|---|---|
| Personalized Fetal Images Through Virtual Reality | Experimental | Behavioral: Virtual RealityParticipants in this arm will view personalized fetal ultrasound images accompanied by fetal heart sounds using a virtual reality headset during the first stage of labor. |
| Routine Intrapartum Care | No intervention | –Participants in this group received routine intrapartum care according to the hospital protocol. No additional intervention was provided. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women aged 18 years or older
- Primiparous women
- Gestational age of 28-32 weeks at the time of eligibility assessment
- Singleton pregnancy
- Able to communicate in Turkish
Key exclusion criteria (4 listed)
- Indication for elective cesarean delivery
- Visual or hearing impairment that could interfere with the intervention
- Maternal or fetal medical complications
- Pregnancy conceived through assisted reproductive techniques
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 RealityAlso: Fetal Images Through Virtual RealityParticipants in the intervention group will view personalized fetal ultrasound images recorded during routine antenatal ultrasonography using a virtual reality headset during the first stage of labor. The fetal ultrasound images will be accompanied by fetal heart sounds. The intervention will be administered when cervical dilatation reaches 4-9 cm in a quiet environment. Each viewing session will last for at least 4 minutes, and participants will be allowed to continue viewing according to their preference. The duration of VR exposure will be recorded for each participant. | Behavioural | Personalized Fetal Images Through Virtual Reality |
Primary outcome
Maternal Attachment
Time frame: 30 days postpartum.
Maternal attachment will be assessed using the Maternal Attachment Scale. Higher scores indicate stronger maternal attachment.
Childbirth Comfort
Time frame: During active labor, at 8 cm cervical dilatation.
Childbirth comfort will be assessed using the Childbirth Comfort Questionnaire (CCQ), a 9-item, 5-point Likert-type scale consisting of physical, psychospiritual, and environmental comfort subscales. Total scores range from 9 to 45, with higher scores indicating greater childbirth comfort.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Childbirth, run by Selcuk 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 28 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Attachment (time frame: 30 days postpartum.). The study lists 2 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 28 Aug 2026.