AnxietyNCT07280910
Exploring Virtual Reality in Clinical Care - Impacts on Patient Distress, Parental Anxiety and Nurse Satisfaction
An observational study of Anxiety, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Prior experience with virtual reality (VR) in clinical care has demonstrated its potential to reduce patient anxiety and distress, particularly in pediatric settings. VR has been shown to effectively decrease preoperative anxiety in children undergoing various medical procedures, including IV catheter replacement… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual Reality, Survey Responses/Parent Caregivers and Survey Responses/Nurses
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study involved pediatric patients who received VR intervention as part of the original QI initiative. Data protection and de-identification procedures were rigorously applied throughout the study
Who may be able to join
- pediatric patients who received VR intervention as part of the original QI initiative.
- pediatric patients who were eligible and received VR during the QI initiative aged 6-15 years.
- pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years
- nurses of pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years
Who cannot join
- Patients with developmental delays, head injuries, or seizures were excluded from the study.
- Only those pediatric patients who met the inclusion criteria and did not exhibit the specified exclusion conditions were included. Data protection and de-identification procedures were rigorously applied throughout the study
- Caregivers/Parents
- N/A
- Nurses
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Retrospective Observational Study Analyzing De-identified Data Originally Collected as Part of a Quality Improvement (QI) Initiative.
Prior experience with virtual reality (VR) in clinical care has demonstrated its potential to reduce patient anxiety and distress, particularly in pediatric settings. VR has been shown to effectively decrease preoperative anxiety in children undergoing various medical procedures, including IV catheter replacement, blood draws, and improve their compliance with anesthesia and overall procedural experiences. Limited evidence exists regarding the impact of VR on the broader care environment, including parental anxiety and nursing satisfaction in pediatric settings.
Read the detailed description
This retrospective study analyzes de-identified data from a nine-month quality improvement initiative to evaluate the impact of a custom VR intervention on pediatric preoperative anxiety, parental anxiety, and nurse satisfaction in a real clinical setting. The findings offer preliminary, practice-relevant evidence that VR can be a feasible, acceptable, and clinically meaningful non-pharmacologic tool in pediatric preoperative care, and they provide actionable insights to guide future implementation efforts and rigorous trials aimed at improving the hospital experience for children, families, and providers.
- Conditions
- Anxiety
- Being tested
- Virtual Reality, Survey Responses/Parent Caregivers, Survey Responses/Nurses
- Keywords
- Virtual Reality, Quality Improvement, Protected Health Information, Heart Rate, Blood Pressure, State-Trait Anxiety Inventory
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Administered as part of a QI initiative aimed at reducing anxiety in pediatric patients during clinical care. The intervention involved using a VR system to provide a distraction and relaxation tool during routine procedures. This approach is consistent with recent research showing that VR can be an effective tool for reducing pain and anxiety in pediatric patients undergoing medical procedures. Retrospective data collection.
Survey Responses/Parent CaregiversBehavioural
Survey responses from parents regarding anxiety and satisfaction.
Survey Responses/NursesBehavioural
Survey responses from nurses regarding anxiety and satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients | Pediatric patients receiving VR interventions (6-15 years) Receives: Other: Virtual Reality | |
| Parent Caregivers | Parents of Pediatric patients receiving VR interventions (6-15 years) Receives: Behavioral: Survey Responses/Parent Caregivers | |
| Nurses | The nursing staff are involved in the care process of the Pediatric patients receiving VR interventions (6-15 years) Receives: Behavioral: Survey Responses/Nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient anxiety levels, as measured by heart rate
Change in patient anxiety levels, as measured by heart rate, before and after VR intervention. Baseline heart rate will be compared to the heart rate after the intervention.
Measured: Before and after VR intervention, one visit only
Change in patient anxiety levels, as measured by blood pressure
Change in patient anxiety levels, as measured by blood pressure, before and after VR intervention. Baseline blood pressure will be compared to the blood pressure after the intervention.
Measured: Before and after VR intervention, one visit only
Change in patient anxiety levels, as measured by distress/fear scores
Change in patient anxiety levels, as measured by distress/fear scores before and after VR intervention Baseline distress/fear scores will be compared to the distress/fear scores after the intervention. Using the Children's Fear Scale (CFS) (0-4):
- 0 = no fear (good)
- 4 = very high fear (bad) . Higher scores indicate worse anxiety. Anxiety levels were measured immediately before and immediately after the VR intervention).
Measured: Before and after VR intervention, one visit only
Secondary outcomes (2)
Parental anxiety levels
Change in parental anxiety levels, measured by pre- and post-intervention State-Trait Anxiety Inventory (STAI) scores. The State-Trait Anxiety Inventory (STAI) scoring involves summing the scores from the 40 items, each rated on a 4-point Likert scale, to assess state and trait anxiety. The higher the score, the higher the level of anxiety.
- = Not at all
- = Somewhat
- = Moderately so
- = Very much so
Measured: Before and after VR intervention, one visit only
Nurse satisfaction ratings
Nurse satisfaction ratings with the VR intervention, measured via survey responses. Nurse satisfaction with the VR intervention was measured using a brief, Likert-scale survey developed for this quality improvement project.
Survey Format: A 5-point Likert scale was used for all items:
- 1 = Very Dissatisfied / Very Difficult (bad)
- 2 = Dissatisfied
- 3 = Neutral
- 4 = Satisfied
- 5 = Very Satisfied / Very Easy to Use (good) Higher scores indicate better satisfaction and more straightforward implementation.
Measured: Before and after VR intervention, one visit only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dayanjan Wijesinghe, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280910
- Sponsor's protocol ID
- HM20032312
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Study Analyzing De-identified Data Originally Collected as Part of a Quality Improvement (QI) Initiative.
- ClinicalTrials.gov ID
- NCT07280910
- Acronym / sponsor ID
- HM20032312
- Conditions
- Anxiety
- Keywords
- Virtual Reality, Quality Improvement, Protected Health Information, Heart Rate, Blood Pressure, State-Trait Anxiety Inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Dec 2025 (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.
Prior experience with virtual reality (VR) in clinical care has demonstrated its potential to reduce patient anxiety and distress, particularly in pediatric settings. VR has been shown to effectively decrease preoperative anxiety in children undergoing various medical procedures, including IV catheter replacement, blood draws, and improve their compliance with anesthesia and overall procedural experiences. Limited evidence exists regarding the impact of VR on the broader care environment, including parental anxiety and nursing satisfaction in pediatric settings.
Detailed description
This retrospective study analyzes de-identified data from a nine-month quality improvement initiative to evaluate the impact of a custom VR intervention on pediatric preoperative anxiety, parental anxiety, and nurse satisfaction in a real clinical setting. The findings offer preliminary, practice-relevant evidence that VR can be a feasible, acceptable, and clinically meaningful non-pharmacologic tool in pediatric preoperative care, and they provide actionable insights to guide future implementation efforts and rigorous trials aimed at improving the hospital experience for children, families, and providers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients | – | Other: Virtual RealityPediatric patients receiving VR interventions (6-15 years) |
| Parent Caregivers | – | Behavioral: Survey Responses/Parent CaregiversParents of Pediatric patients receiving VR interventions (6-15 years) |
| Nurses | – | Behavioral: Survey Responses/NursesThe nursing staff are involved in the care process of the Pediatric patients receiving VR interventions (6-15 years) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study involved pediatric patients who received VR intervention as part of the original QI initiative. Data protection and de-identification procedures were rigorously applied throughout the study
Key inclusion criteria (4 listed)
- pediatric patients who received VR intervention as part of the original QI initiative.
- pediatric patients who were eligible and received VR during the QI initiative aged 6-15 years.
- pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years
- nurses of pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years
Key exclusion criteria (6 listed)
- Patients with developmental delays, head injuries, or seizures were excluded from the study.
- Only those pediatric patients who met the inclusion criteria and did not exhibit the specified exclusion conditions were included. Data protection and de-identification procedures were rigorously applied throughout the study
- Caregivers/Parents
- N/A
- Nurses
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 RealityAdministered as part of a QI initiative aimed at reducing anxiety in pediatric patients during clinical care. The intervention involved using a VR system to provide a distraction and relaxation tool during routine procedures. This approach is consistent with recent research showing that VR can be an effective tool for reducing pain and anxiety in pediatric patients undergoing medical procedures. Retrospective data collection. | Other | Pediatric Patients |
| Survey Responses/Parent CaregiversSurvey responses from parents regarding anxiety and satisfaction. | Behavioural | Parent Caregivers |
| Survey Responses/NursesSurvey responses from nurses regarding anxiety and satisfaction. | Behavioural | Nurses |
Primary outcome
Change in patient anxiety levels, as measured by heart rate
Time frame: Before and after VR intervention, one visit only
Change in patient anxiety levels, as measured by heart rate, before and after VR intervention. Baseline heart rate will be compared to the heart rate after the intervention.
Change in patient anxiety levels, as measured by blood pressure
Time frame: Before and after VR intervention, one visit only
Change in patient anxiety levels, as measured by blood pressure, before and after VR intervention. Baseline blood pressure will be compared to the blood pressure after the intervention.
Change in patient anxiety levels, as measured by distress/fear scores
Time frame: Before and after VR intervention, one visit only
Change in patient anxiety levels, as measured by distress/fear scores before and after VR intervention Baseline distress/fear scores will be compared to the distress/fear scores after the intervention. Using the Children's Fear Scale (CFS) (0-4): * 0 = no fear (good) * 4 = very high fear (bad) . Higher scores indicate worse anxiety. Anxiety levels were measured immediately before and immediately after the VR intervention).
2 secondary outcomes
Parental anxiety levels
Time frame: Before and after VR intervention, one visit only
Nurse satisfaction ratings
Time frame: Before and after VR intervention, one visit only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dayanjan Wijesinghe principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Virginia Commonwealth University at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 12 Dec 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient anxiety levels, as measured by heart rate (time frame: Before and after VR intervention, one visit only). The study lists 3 primary outcomes in all. 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 12 Dec 2025.