Lucile Parkard Children's Hospital
Stanford, California, 94304, United States
NCT Number: NCT05729347
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Stanford, California, 94304, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes
Time frame: immediately after the intervention
Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.
Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.
Time frame: baseline, immediately after the intervention
The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety.
Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.
Time frame: immediately after intervention
To evaluate the overall impact of device satisfaction, participants will complete the self-developed satisfaction survey. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = a lot.
Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.
Time frame: immediately after intervention
Modified Pain Catastrophizing Scale(PCS); It is a self-report measure adapted from the Adult Pain Catastrophizing Scale used to assess negative thinking associated with pain. It contains 3 items rated on a 5-point scale ranging from 0 = "not at all" to 4 = "very much".
Time frame: Duration of intervention, approximately 20-30 minutes
Validated questionnaires regarding anxiety will be administers pre- and post-intervention (i.e virtual reality) and compared to those in the control arm (i.e no virtual reality)
Stanford University
Other
Treatment of Parental Anxiety With Virtual Reality (VR): A Prospective, Randomized Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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