Immersive 360-Degree Virtual Reality Simulator for Preparing Women for Vaginal Birth: Development and Pilot Study

The primary objective of this study is to design, develop, and conduct a preliminary evaluation of a virtual reality simulator based on 360-degree videos

Pilot randomized controlled trial with two parallel groups including an intervention group (360-degree virtual reality) and a control group (routine face-to-face education) in 24 pregnant women (12 per group). Randomization will be performed using block randomization with allocation concealment. The study is single-center.

The study will be conducted at Taleghani Hospital, Tabriz, Iran. Pregnant women will be recruited via convenience sampling after informed consent.

Pregnant women attending Taleghani Hospital, Tabriz, will be recruited by convenience sampling after informed consent. Inclusion: singleton pregnancy, 20–36 weeks, age 18–45, residence in Tabriz area, literacy in Persian, access to smartphone and internet, and willingness to participate. Exclusion: high-risk pregnancy, severe fear of childbirth (WDEQA >85), major medical or psychiatric disorders, intolerance to virtual reality, or withdrawal.

Participants will be randomly assigned to two parallel groups. The intervention group will receive 360-degree virtual reality-based childbirth education including breathing, relaxation, labor positions, pain management, and partner support, with optional online access. The control group will receive routine face-to-face childbirth education based on national guidelines.

Fear of childbirth; childbirth self efficacy; perceived presence in virtual reality; system usability and user experience; physical preparedness for childbirth skills; feasibility and acceptability of the VR intervention

Eligible pregnant women will be randomized individually into either the intervention group or the control group with a 1:1 allocation ratio. Randomization will be performed using block randomization with variable block sizes of four and six in order to maintain balance between groups during the recruitment period. The unit of randomization will be the individual participant. The random allocation sequence will be generated by computer using an online randomization generator by a researcher not involved in participant recruitment or outcome assessment. The sequence will be prepared before the start of recruitment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. After confirming eligibility criteria and obtaining written informed consent, the researcher will open the next envelope in sequence and assign the participant to either the intervention or control group accordingly. Because of the nature of the intervention (virtual reality simulator versus routine face-to-face childbirth preparation), blinding of participants and the main researcher will not be feasible.

Deidentified participant level data related to the primary and secondary outcomes of the study, including childbirth preparedness, fear of childbirth, childbirth self efficacy, usability of the virtual reality simulator, and sense of presence questionnaires. The study protocol, informed consent form, and data collection tools may also be shared upon reasonable request after publication of the study results. All shared data will be anonymized and provided in a way that protects participant confidentiality

The study documents and deidentified participant data will be available starting 6 months after publication of the study results and will remain available for 5 years upon reasonable request to the principal investigator.

Qualified researchers, academic investigators, and postgraduate students affiliated with recognized academic or research institutions may request access to deidentified data and study documents for scientific research purposes.

Data and study documents will be shared upon reasonable request for scientific research, secondary analysis, or academic purposes. Requests will be reviewed by the principal investigator. Shared data must remain deidentified, be used only for approved research purposes, and not be transferred to third parties without permission.

Data and study documents will be available upon reasonable request from the Principal Investigator, Nafiseh Mohammadkhani, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Requests may be submitted by email to mohammadkhaninafiseh@gmail.com. Postal correspondence may be sent to Miyaneh Azadegan-e Jonubi Street, 17th Alley, No. 50 postal code: 5317644361. The preferred method of contact is email.

Requests to access study data or documents must be submitted via email to the Principal Investigator, including a brief description of the research purpose and proposed analysis. The Principal Investigator will review the request for scientific merit and ethical compliance. If necessary, clarification or additional documentation may be requested. Approved requests will require a data use agreement to ensure confidentiality and appropriate use of deidentified data. After final approval, data will be prepared and shared electronically in a secure format. The entire process is expected to take approximately 2 to 4 weeks depending on the completeness of the request and review time.