- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04942561
VR to Reduce Pain/Anxiety During IV Starts
28 juni 2021 uppdaterad av: Jeffrey I Gold, PhD, Children's Hospital Los Angeles
Effect of Immersive Virtual Reality on Pain and Anxiety in Pediatric Peripheral Intravenous Catheter Access: A Randomized Clinical Trial
This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center at CHLA, as measured by self- and proxy-report.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Distraction is a form of non pharmacological intervention for reducing pain and anxiety in children during painful medical procedures (e.g., venipuncture, IV placement).
Recent technological developments in the area of virtual reality (VR) provide new and potentially more effective ways of distracting children from the pain and anxiety associated with medical procedures.
While initial studies of VR pain distraction are promising, few have studied the effectiveness of the technology in children, using a multi-method approach.
The current study aims to recruit 115 children ages 10-21 years and their caregivers who arrive at the hospital for peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center.
Children and their parents will be randomly assigned to one of two treatment conditions: 1) existing hospital standard of care or 2) standard of care plus distraction via VR.
Children and caregivers will be asked to complete measures assessing pain and anxiety both before and after the procedure.
In addition, objective measures of child pain and distress during the PIVC access will be taken using coding of behavioral/verbal expressions.
Univariate Analysis of Variance (ANOVA) will be used to compare differences in primary and secondary outcome variables in VR + standard of care to standard of care only conditions when pre and post-operative measures are available.
Univariate ANOVA will be used to compare conditions on post-operative variables.
Studietyp
Interventionell
Inskrivning (Faktisk)
107
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Los Angeles, California, Förenta staterna, 90027
- Children's Hospital Los Angeles
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
10 år till 21 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria for Children:
- Children who are 10-21 years old
- Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
- Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.
- Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.
Inclusion criteria for healthcare providers:
- Healthcare providers must be 18 years old or older
- Healthcare providers must be Children's Hospital Los Angeles staff
- Healthcare providers may participate if they have witnessed and/or administered the medical procedure
Exclusion Criteria:
- Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
- Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
- Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
- Children with a history of seizure disorder.
- Children currently sick with flu-like symptoms or experiencing a headache or earache.
- Children with known or suspected motion sickness
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Standard of Care (No VR) Randomization
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for PIVC placement (i.e., a topical numbing spray and Buzzy® Bee, a vibrating device placed near the PIVC site for pain distraction).
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Experimentell: VR Randomization
Children in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD).
The intervention group will receive standard CHLA treatment with VR distraction.
Patients began gameplay <5 minutes before their PIVC placement and concluded after successful vascular access.
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Participants 13 -21 years old can use the Samsung Gear VR.
The VE is mobile based (Samsung with the Gear VR) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.
Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears.
The VR game is equipped with a head-tracking system, enabling the player to look around the VE.
Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience.
While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased.
The VR glasses will be sanitized before every use to minimize chance of infection.
Participants 10-21 years can use the Merge.
The VE to be used in this study is mobile based (Pixel with the Merge) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.
Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears.
The VR game is equipped with a head-tracking system, enabling the player to look around the VE.
Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience.
While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased.
The VR glasses will be sanitized before every use to minimize chance of infection.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Faces Pain Scale-Revised (FPS-R)
Tidsram: Cirka 5 minuter till en timme före proceduren
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Reviderad är en uppdaterad version av Wong-Baker Faces Pain Rating Scale som visar ingen smärta som ett neutralt uttryck jämfört med det leende ansiktet i det ursprungliga måttet.
Barnet uppmanas att peka på ansiktstecknad film som skildrar hur det just nu mår på grund av sin smärta.
Ansiktsmått tros mäta smärtintensitet, och Wong-Baker Faces-måttet har visat god tillförlitlighet och validitet.
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Cirka 5 minuter till en timme före proceduren
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Visual Analogue Scale (VAS)
Tidsram: Approximately 5 minutes to one hour before procedure
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The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task.
The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top.
Prior research used the VAS to rate anticipatory anxiety and pain in children
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Approximately 5 minutes to one hour before procedure
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Childhood Anxiety Sensitivity Index (CASI)
Tidsram: Cirka 5 minuter till en timme före proceduren
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Detta mått med 18 punkter använder en tregradig Likert-skala (ingen (1), några (2), mycket (3)) för att bedöma hur negativt patienter ser på ångestsymtom.
Objekt summeras med en högre poäng, vilket indikerar större ångestkänslighet.
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Cirka 5 minuter till en timme före proceduren
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Gold & Rizzo Immersion/Presence (GRIP) Inventory
Tidsram: Approximately 5 minutes to one hour before procedure
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Gold & Rizzo Immersion/Presence (GRIP) Inventory is a Child Presence Questionnaire was developed out of a content analysis of the entire domain of adult presence items and selection and adaptation of appropriate items for assessing the child's sense of believability of their experience.
This 16-item measure is verbally administered to children and asks them to respond according to a 3-point Likert-like format.
Items assess the child's sense of involvement, realism, and transportation into the experience.
Patients in the VR condition will complete the Child Presence Questionnaire post-procedure to assess level of VR immersion.
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Approximately 5 minutes to one hour before procedure
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Sponsor
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Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 april 2017
Primärt slutförande (Faktisk)
24 juli 2019
Avslutad studie (Faktisk)
24 juli 2019
Studieregistreringsdatum
Först inskickad
18 juni 2021
Först inskickad som uppfyllde QC-kriterierna
18 juni 2021
Första postat (Faktisk)
28 juni 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juli 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juni 2021
Senast verifierad
1 juni 2021
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- CHLA-15-00549_A
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