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IRCT20220926056046N8 IRCT 2026-08-29 Tabriz University of Medical Sciences Development and Initial Evaluation of a 360-Degree Virtual Reality Simulator for Preparing Pregnant Women for Vaginal Birth Immersive 360-Degree Virtual Reality Simulator for Preparing Women for Vaginal Birth: Development and Pilot Study 2026-10-20 anticipated 24 Recruiting https://irct.ir/trial/92240 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 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. N/A Fear of childbirth. Intervention 1: Intervention group: Pregnant women will receive childbirth preparation training using a 360 degree video based virtual reality simulator. The content includes breathing techniques, relaxation exercises, labor positions, non pharmacological pain management methods, and the supportive role of a birth companion. The intervention is delivered in a supervised clinical setting using a virtual reality headset in a seated position. Each session lasts 15 to 20 minutes. Intervention 2: Control group: Pregnant women will receive routine face to face childbirth preparation education in the same clinical setting. The education follows national standard guidelines and includes breathing exercises, pelvic movements, labor positions, and non pharmacological pain relief methods. Yes - There is a plan to make this available What will be shared: 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 When: 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. To whom: 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. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Solmaz Ghanbari Homaie
East Azerbaijan Province, Tabriz, Rahahan Sq, Taleghani hospital
Tabriz Iran (Islamic Republic of) 5197615413 +41 34424420 homayisolmaz@gmail.com Tabriz University of Medical Sciences scientific Solmaz Ghanbari Homaie
East Azerbaijan Province, Tabriz, Rahahan Sq, Taleghani hospital
Tabriz Iran (Islamic Republic of) 5197615413 +41 34424420 homayisolmaz@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Pregnant women with singleton pregnancy Gestational age between 20 and 36 weeks Maternal age between 18 and 45 years Residence in Tabriz or nearby areas Minimum literacy (ability to read and write Persian) to complete questionnaires and use simulator content Willingness to participate and signing written informed consent No history of epilepsy or uncontrolled seizure disorders No severe dizziness, vestibular disorders, or serious visual/hearing impairment interfering with VR use No previous severe intolerance to virtual reality No severe psychiatric disorders (including psychosis, active bipolar disorder, or severe depression) based on self-report/medical history No simultaneous participation in similar educational programs or other interventional studies Access to internet Access to a smartphone Adequate visual ability for VR use (self-reported; no visual problems interfering with depth perception) 18 years 45 years Female High-risk pregnancy including severe preeclampsia or gestational hypertension Uncontrolled gestational diabetes Vaginal bleeding during pregnancy Intrauterine growth restriction History or evidence of preterm labor in the current pregnancy Severe fear of childbirth (W-DEQ-A score >85) Severe intolerance to VR during the first session (severe dizziness, uncontrollable nausea, severe headache, seizure-like symptoms) Development of any medical condition during the study making participation unsafe Withdrawal of consent O99.3 Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium Early detection Early detection Intervention group: Pregnant women will receive childbirth preparation training using a 360 degree video based virtual reality simulator. The content includes breathing techniques, relaxation exercises, labor positions, non pharmacological pain management methods, and the supportive role of a birth companion. The intervention is delivered in a supervised clinical setting using a virtual reality headset in a seated position. Each session lasts 15 to 20 minutes. Control group: Pregnant women will receive routine face to face childbirth preparation education in the same clinical setting. The education follows national standard guidelines and includes breathing exercises, pelvic movements, labor positions, and non pharmacological pain relief methods. Childbirth preparedness. Timepoint: Baseline (before intervention) and immediately after completion of the training sessions. Method of measurement: Researcher-developed birth preparedness checklist score. Childbirth self efficacy. Timepoint: Immediately after completion of the training sessions; and one week after the end of the intervention. Method of measurement: Childbirth Self Efficacy Inventory. Fear of childbirth. Timepoint: Baseline (before intervention); immediately after completion of the training sessions; and one week after the end of the intervention. Method of measurement: Wijma Questionnaire (W-DEQ). Usability of the virtual reality simulator. Timepoint: Immediately after the first exposure/session (post intervention). Method of measurement: System Usability Scale. Sense of presence. Timepoint: Immediately after the virtual reality intervention session (post-exposure only). Method of measurement: I group Presence Questionnaire (IPQ). Tabriz University of Medical Sciences Approved 2026-04-18 Ethics committee of Tabriz University of Medical Sciences Central Building, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, Iran. Tabriz East Azarbaijan Iran (Islamic Republic of)