NCT07410858

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 7, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

Virtual RealityNeonatal Intensive Care UnitsParent EducationPremature Infant

Outcome Measures

Primary Outcomes (1)

  • Parental Neonatal Intensive Care Unit Caregiving Practices

    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

Study Arms (2)

VR-Enhanced Parent Education

EXPERIMENTAL

Participants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing.

Behavioral: Virtual Reality-Enhanced Parent Education

Standard Parent Education

NO INTERVENTION

Participants receive routine NICU parent education including verbal instructions and printed educational materials according to unit standard practice.

Interventions

Participants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing.

Also known as: Standard Parent Education
VR-Enhanced Parent Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit (NICU), Suez Canal University Hospital

Ismailia, Ismailia, Egypt., 41522, Egypt

RECRUITING

MeSH Terms

Conditions

Premature BirthBehavior

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Nadia B. Elsharkawy, Assoc.Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the educational intervention, participants and care providers cannot be blinded to group assignment. However, trained observers assessing parental caregiving practices and data analysts will remain blinded to allocation to reduce assessment bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a single-center, parallel-group, randomized pilot clinical trial comparing virtual reality-enhanced parent education with standard NICU parent education. Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving VR-enhanced education or the control group receiving routine education. Both groups will be followed concurrently to evaluate feasibility, parental knowledge, caregiving practices, and intervention tolerability.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

January 1, 2026

Primary Completion

March 31, 2026

Study Completion

April 30, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers. Data generated during this study will remain confidential and will only be used for the purposes outlined in this trial.

Locations