Neonatal Intensive Care UnitsNCT07410858
Virtual Reality-Enhanced Parent Education in Neonatal Intensive Care
A study testing Virtual Reality-Enhanced Parent Education in people with Neonatal Intensive Care Units and Premature Infant, run by Jouf University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neonatal Intensive Care Units, Premature Infant, Parent Education
- What is being tested?
- Virtual Reality-Enhanced Parent Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Neonatal Intensive Care Unit (NICU), Suez Canal University Hospital
Ismailia, Ismailia, Egypt., 41522
Lareen M. Abo-Seif, Lecturer, Faculty.of.nursing@nursing.suez.edu.eg
Osama M. Ramadan, Lecturer, 00966580408319, Omer@ju.edu.sa
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Intensive Care Units, Premature Infant, Parent Education, Virtual Reality, Health Knowledge, Attitudes, Practice
- Being tested
- Virtual Reality-Enhanced Parent Education
- Keywords
- Virtual Reality, Neonatal Intensive Care Units, Parent Education, Premature Infant
- Medical subject headings
- Premature Birth, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Enhanced Parent EducationBehavioural
Also called Standard 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24-48 hours after completion of the parent education intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jan 2026
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Intensive Care UnitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Elsharkawy, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410858
- Sponsor's protocol ID
- 351-12-2025
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-Enhanced Parent Education and Its Effect on Neonatal Intensive Care Practices: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07410858
- Acronym / sponsor ID
- 351-12-2025
- Conditions
- Neonatal Intensive Care Units, Premature Infant, Parent Education, Virtual Reality, Health Knowledge, Attitudes, Practice
- Keywords
- Virtual Reality, Neonatal Intensive Care Units, Parent Education, Premature Infant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR-Enhanced Parent Education | Experimental | Behavioral: Virtual Reality-Enhanced Parent EducationParticipants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing. |
| Standard Parent Education | No intervention | –Participants receive routine NICU parent education including verbal instructions and printed educational materials according to unit standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Enhanced Parent EducationAlso: Standard Parent EducationParticipants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing. | Behavioural | VR-Enhanced Parent Education |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Enhanced Parent Education in people with Neonatal Intensive Care Units and Premature Infant, run by Jouf University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia B. Elsharkawy, Assoc.Prof. (00966554180474, nelsharkawy@ju.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Neonatal Intensive Care Unit Caregiving Practices (time frame: Within 24-48 hours after completion of the parent education intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.