- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280910
Exploring Virtual Reality in Clinical Care - Impacts on Patient Distress, Parental Anxiety and Nurse Satisfaction
Retrospective Observational Study Analyzing De-identified Data Originally Collected as Part of a Quality Improvement (QI) Initiative.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Pediatric Subjects
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Inclusion Criteria:
- pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years
Exclusion Criteria:
- N/A
Nurses
Inclusion Criteria:
- nurses of pediatric patients who were eligible and received VR during the QI initiative, aged 6-15 years
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pediatric Patients
Pediatric patients receiving VR interventions (6-15 years)
|
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.
|
|
Parent Caregivers
Parents of Pediatric patients receiving VR interventions (6-15 years)
|
Survey responses from parents regarding anxiety and satisfaction.
|
|
Nurses
The nursing staff are involved in the care process of the Pediatric patients receiving VR interventions (6-15 years)
|
Survey responses from nurses regarding anxiety and satisfaction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Before and after VR intervention, one visit only
|
|
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.
|
Before and after VR intervention, one visit only
|
|
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):
|
Before and after VR intervention, one visit only
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental anxiety levels
Time Frame: Before and after VR intervention, one visit only
|
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.
|
Before and after VR intervention, one visit only
|
|
Nurse satisfaction ratings
Time Frame: Before and after VR intervention, one visit only
|
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:
|
Before and after VR intervention, one visit only
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dayanjan Wijesinghe, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20032312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
Clinical Trials on Virtual Reality
-
Institut National de la Santé Et de la Recherche...RecruitingSchizophrenia | Bipolar DisorderFrance
-
Eskisehir Osmangazi UniversityNot yet recruiting
-
The University of Hong KongCompleted
-
University of PennsylvaniaRecruiting
-
Istanbul University - CerrahpasaCompletedCancer | AnxietyTurkey
-
Cihat OzyılmazCompletedChild | Anxiety | FearTurkey
-
National University of MalaysiaRecruitingPleural EffusionMalaysia
-
Stanford UniversityTerminatedConversion Disorder | Non-epileptic Seizures | Functional Neurological Disorder | Functional Movement Disorder | Psychogenic Movement DisorderUnited States
-
University of WashingtonNational Institutes of Health (NIH); University of Texas; National Institute...Completed
-
Children's Hospital Los AngelesNot yet recruitingProcedural Pain | Procedural Anxiety