Virtual Reality for Pain Management Study
1 juin 2021 mis à jour par: Mark B. Powers, University of Texas at Austin
Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective means of decreasing pain levels following treatment, and for significant periods of time.
Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity associated with pain.
While VR is clearly a promising, drug-free option for pain treatment, existing VR systems are expensive and use unconvincing graphics.
Recent advances in VR technology (i.e., improved realism and immersion using 360-degree 3D technology and more affordable delivery systems) allow the development of more realistic and more cost-effective applications.
Capitalizing on these advances and the investigators' experiences with VR intervention development and evaluation, the current study will test a state-of-the-art VR experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and compare it to established standard computer generated imagery (CGI) 360° VVR content for pain management intervention in a medical setting.
The participant's participation will help the investigators determine which VR intervention is most effective in reducing acute pain in hospital patients.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
103
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Texas
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Austin, Texas, États-Unis, 78712
- University of Texas at Austin
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Between the ages of 18 and 65
- Reports experiencing current pain not typical of day-to-day experience during Pre-Treatment Pain Questionnaire at the onset of study visit by answering "Yes" to the first question of the questionnaire. There is no specific threshold of how much pain the participant must be in to be eligible for this study. The participant must be experiencing current pain that is not related to day-to-day, normal experiences (such as minor headaches, sprains, and toothaches).
- Scores a 15 on the Glasgow Coma Scale and a 7 or above on the abbreviated Mini Mental Status Exam.
- Patient in the acute and critical palliative care units, post surgical units, or acute care orthopedic units at University Medical Center Brackenridge in Austin, TX.
- Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.
Exclusion Criteria:
- Hearing or visually impaired where participant cannot use the Samsung Gear VR.
- Does not report experiencing current pain during Pre-Treatment Pain Questionnaire at the onset of study visit.
- Scores below a 15 on the Glasgow Coma Scale and/or below a 7 on the abbreviated Mini Mental Status Exam
- Limited mental competency and the inability to give informed, voluntary, written consent to participate.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Live-Action 360° Video Virtual Reality
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360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event.
Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD).
Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event.
Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video.
The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
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Comparateur actif: CGI 360° Video Virtual Reality
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Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display.
Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
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Aucune intervention: Waitlist
Participants randomized to the waitlist group will complete all study procedures except the VR exposure.
After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Post-Treatment Pain Questionnaire
Délai: Immediately following intervention
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The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment.
It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad.
Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine.
Pain is current
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Immediately following intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Follow-Up Pain Questionnaire
Délai: Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
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The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment.
It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad.
Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine.
Pain is current
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Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
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Presence Inventory
Délai: Immediately following intervention
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Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence.
Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity.
Higher for these two subscales indicate a better outcome.
Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects.
Higher scores for this subscale indicate a worse outcome.
Questions on the scale are summed.
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Immediately following intervention
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Absorption Survey
Délai: Immediately after intervention
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Self-report measure that assesses participant engagement with the virtual world.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
There are 12 questions with a total score of 120.
Higher scores indicate a better outcome and increased participant engagement.
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Immediately after intervention
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Present Mood Questionnaire
Délai: Every 10 minutes for 40 minutes following intervention
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The Present Mood Questionnaire was used to assess the participant's current mood.
The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil.
It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden.
Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.
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Every 10 minutes for 40 minutes following intervention
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Attitudes Toward the Experience Survey
Délai: Immediately after intervention
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Self-report measure that assesses the participant's attitude toward the VR experience.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
There are 12 questions for a total score of 120.
Higher scores mean a more positive attitude towards the experience and is a better outcome.
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Immediately after intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mark Powers, Ph.D., University of Texas at Austin
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2017
Achèvement primaire (Réel)
1 juillet 2018
Achèvement de l'étude (Réel)
1 juillet 2018
Dates d'inscription aux études
Première soumission
15 décembre 2016
Première soumission répondant aux critères de contrôle qualité
15 décembre 2016
Première publication (Estimation)
19 décembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 juin 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juin 2021
Dernière vérification
1 juin 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2016-09-0140
Plan pour les données individuelles des participants (IPD)
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