NCT07793136

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

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
completed

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 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 19, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Childbirth comfort; maternal attachment; perceived traumatic birth; virtual reality; labor;childbirth comfortmaternal attachmentperceived traumatic birthvirtual reality

Outcome Measures

Primary Outcomes (2)

  • Maternal Attachment

    Maternal attachment will be assessed using the Maternal Attachment Scale. Higher scores indicate stronger maternal attachment.

    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.

    During active labor, at 8 cm cervical dilatation.

Study Arms (2)

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.

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.

Interventions

Virtual RealityBEHAVIORAL

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.

Also known as: Fetal Images Through Virtual Reality
Personalized Fetal Images Through Virtual Reality

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details18-35 years old women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 28, 2026

Study Start

January 30, 2026

Primary Completion

April 15, 2026

Study Completion

April 30, 2026

Last Updated

August 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations