Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes |
|
| Control | No Intervention | No intervention (i.e. virtual reality headset) will be applied to the participant. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality headset with calming scenery | Behavioral | Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety levels | 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. | immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Parkard Children's Hospital | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35402359 | Background | Chang ZY, Kang GC, Koh EYL, Fong RJK, Tang J, Goh CK, Tan NC. Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial. Front Pediatr. 2022 Mar 25;10:847257. doi: 10.3389/fped.2022.847257. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| baseline, immediately after the intervention |
| Device satisfaction | 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. | immediately after intervention |
| Modified Pain Catastrophizing Scale | 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". | immediately after intervention |
| Procedural-Related Anxiety | 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) | Duration of intervention, approximately 20-30 minutes |