Behandling af forældrenes angst Virtual Reality (VR)
Behandling af forældres angst med virtuel virkelighed (VR): En prospektiv, randomiseret undersøgelse
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
Stanford, California, Forenede Stater, 94304
- Lucile Parkard Children's Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Alder 18-99 (Patientens forældre vil blive tilmeldt)
- Kan give samtykke
Ekskluderingskriterier:
- Folk der ikke giver samtykke
- Betydelig kognitiv svækkelse
- Historie om svær køresyge
- Aktuel kvalme
- Anfald
- Synsproblemer Patienter, hvis børn er klinisk ustabile eller kræver akut/emergent intervention
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Virtual reality
Deltagerne vil blive fordybet i et virtuelt miljø.
Beroligende landskab vil blive vist via headsettet i 20-30 minutter
|
Deltagerne vil blive fordybet i et virtuelt miljø.
Beroligende landskab vil blive vist via headsettet i 20-30 minutter
|
|
Ingen indgriben: Styring
Ingen indgriben (dvs.
virtual reality-headset) vil blive anvendt på deltageren.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety levels (General inpatient area, Emergency Department)
Tidsramme: Baseline, 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. |
Baseline, immediately after the intervention
|
|
State-Trait Anxiety Inventory [Heart Center]
Tidsramme: 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 specifically in the Heart Center. |
baseline, immediately after the intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety levels (Heart Center)
Tidsramme: Baseline, 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 specifically in the Heart Center setting. |
Baseline, immediately after the intervention
|
|
State-Trait Anxiety Inventory (General inpatient area, Emergency Department)
Tidsramme: 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. |
baseline, immediately after the intervention
|
|
Caregiver Device satisfaction scale (investigator-developed Satisfaction Questionnaire)
Tidsramme: immediately after intervention
|
To evaluate the overall impact of device satisfaction, participants will complete the self-developed satisfaction survey containing 5 items. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = a lot. Assessed in participants enrolled in general hospital setting and specifically in the Emergency Department setting and Heart Center setting. |
immediately after intervention
|
|
Caregiver-reported acceptability and tolerability of virtual reality (investigator-developed VR Questionnaire)
Tidsramme: immediately after virtual reality intervention
|
Caregiver response to the virtual reality intervention was assessed with an investigator-developed questionnaire administered in English or Spanish after the VR session. Four items assessed relaxation, distraction, willingness to use VR again for a future procedure or hospitalization, and interest in VR; each is scored on a 5-point Likert scale from 1 ("Do not agree at all"/"No interest at all") to 5 ("Completely agree"/"Completely interested"), with higher scores indicating greater acceptability. A final checklist item asked caregivers to indicate whether they experienced any of the following during the virtual reality experience, selecting all that applied: nausea, dizziness, headache, disorientation, eye strain, none of the above, or other. Assessed in participants enrolled in general hospital setting and Heart Center setting. |
immediately after virtual reality intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 69068
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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