- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410858
Virtual Reality-Enhanced Parent Education in Neonatal Intensive Care
Virtual Reality-Enhanced Parent Education and Its Effect on Neonatal Intensive Care Practices: A Randomized Controlled Trial
This randomized pilot clinical trial aims to evaluate the effectiveness and feasibility of virtual reality (VR)-enhanced parent education in improving neonatal intensive care unit (NICU) caregiving practices among parents of hospitalized neonates. The study will also examine the safety and tolerability of VR use among parents.
Researchers will compare VR-enhanced education with standard NICU parent education to determine whether immersive VR training improves parents' knowledge, confidence, and ability to perform caregiving tasks.
Participants will be randomly assigned to receive either VR-enhanced education or standard education. Participants receiving VR education will engage in short immersive sessions demonstrating NICU orientation and caregiving procedures. All participants will complete assessments and observations related to caregiving practices and VR tolerability throughout the study period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The NICU environment presents significant emotional, educational, and practical challenges for parents of preterm or critically ill neonates. Effective parent education is essential for improving caregiving competence, reducing parental anxiety, and supporting family-integrated neonatal care. However, traditional education methods such as verbal instructions and printed materials may be limited by time constraints, parental stress, and variations in health literacy.
Virtual reality technology provides immersive, interactive educational experiences that may enhance understanding, engagement, and retention of caregiving information. VR simulations can provide parents with guided orientation to NICU equipment, caregiving demonstrations, and exposure to real-life caregiving scenarios in a safe, controlled environment.
This study is designed as a single-center, randomized, parallel-group pilot trial conducted in a neonatal intensive care unit setting. The primary purpose of the trial is to evaluate feasibility outcomes including recruitment, adherence, retention, and VR tolerability, as well as to generate preliminary estimates of effect size and variability to inform future large-scale trials.
Participants assigned to the intervention group will receive a standardized VR education package consisting of immersive orientation and caregiving simulation sessions delivered using a VR headset. Sessions will include demonstrations of routine neonatal care activities and structured debriefing discussions to reinforce learning and address parental questions.
Participants assigned to the control group will receive routine NICU parent education delivered through conventional methods currently implemented in clinical practice.
Data collection will include assessments of parental knowledge, direct observation of caregiving practices, and evaluation of VR-related tolerability and user experience. Observations of caregiving practices will be conducted by trained observers who are blinded to group allocation to reduce assessment bias.
The results of this pilot trial will provide essential data regarding feasibility, acceptability, safety, and potential effectiveness of VR-enhanced parent education. Findings will be used to refine intervention procedures, improve study methodology, and support the development of a larger definitive randomized clinical trial aimed at improving neonatal outcomes and family-centered care in NICU settings.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nadia B. Elsharkawy, Assoc.Prof.
- Phone Number: 00966554180474
- Email: nelsharkawy@ju.edu.sa
Study Locations
-
-
Ismailia, Egypt.
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Ismailia, Ismailia, Egypt., Egypt, 41522
- Recruiting
- Neonatal Intensive Care Unit (NICU), Suez Canal University Hospital
-
Contact:
- Lareen M. Abo-Seif, Lecturer
- Email: Faculty.of.nursing@nursing.suez.edu.eg
-
Contact:
- Osama M. Ramadan, Lecturer
- Phone Number: 00966580408319
- Email: Omer@ju.edu.sa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent or legal guardian of a neonate admitted to the Neonatal Intensive Care Unit (NICU) within 72 hours of admission
- Age 18 years or older
- Able to read and understand the study language (Arabic)
- Willing to provide informed consent and participate in study procedures
Exclusion Criteria:
- Parent with a confirmed diagnosis of epilepsy, vestibular disorder, or any medical condition that contraindicates virtual reality exposure
- Parent of a neonate expected to be discharged or transferred within 48 hours
- Parent unable to complete study procedures or assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR-Enhanced Parent Education
Participants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing.
|
Participants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing.
Other Names:
|
|
No Intervention: Standard Parent Education
Participants receive routine NICU parent education including verbal instructions and printed educational materials according to unit standard practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Neonatal Intensive Care Unit Caregiving Practices
Time Frame: Within 24-48 hours after completion of the parent education intervention
|
Parental caregiving practices will be assessed using a structured observational checklist measuring performance of bedside neonatal care activities, including hand hygiene, safe positioning and containment, diapering and basic hygiene, and non-nutritive soothing and clustering of care.
Each checklist item is scored as completed or not completed, with higher total scores indicating better caregiving practice performance.
|
Within 24-48 hours after completion of the parent education intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 351-12-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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