- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01310829
Virtual Reality Intervention in Cancer Genetics
Developing Providers' Communication and Counseling Skills in Cancer Genetics Using Virtual Reality
Aperçu de l'étude
Statut
Les conditions
Description détaillée
If you agree to take part in this study, you will complete questionnaires, have your physiological measurements recorded, and view virtual reality scenes.
Questionnaires:
You will fill out questionnaires before and after viewing the virtual reality scenes. Before viewing the virtual reality scenes, you will answer questions about your demographic, educational and professional background and about the likelihood of becoming engaged in a virtual environment. After viewing the virtual reality scenes, you will answer questions to evaluate the scenes. You also will be asked to provide additional comments about the virtual reality scenes during a brief interview. In total, these questionnaires should take about 30 minutes total to complete.
Physiological Measurements:
Your heart rate and the amount you sweat will be recorded during the virtual reality scene (described below) by applying small sensors to your skin.
After you have completed the first set of questionnaires, you will sit in a recliner and the sensors will be placed on your rib cage and hand. The sensors that measure heart rate will be placed in the following locations: your lower left rib cage, just under your right collar bone, and just under your left collar bone. The sensors that measure the amount you sweat will be placed on the palm of your hand.
The Virtual Reality Scenes:
You will sit in a recliner and be asked to put on a virtual reality helmet, which has goggles and noise-cancelling headphones. You will be told how to wear the helmet and use the hand-held controller.
You will first view a sample virtual reality scene to help orient you to the technology. The experience of virtual reality may involve multiple senses. For example, you may hear, smell, and feel sensations (such as mild vibrations) that are associated with the scenes you are viewing.
After you become comfortable using the technology, you will view a virtual reality scenario that depicts a typical session in cancer genetic counseling. The scenario will depict a virtual patient who is being seen for genetic counseling. You will be encouraged to speak to and interact with the virtual patient as you would with a real patient. The interaction with the virtual patient will be recorded. It is estimated that you will spend about 30 minutes in the genetic counseling scene with the virtual patient.
After the scene has ended, the equipment and sensors will be removed, and you will be asked to complete the second set of questionnaires and the brief interview.
It is expected that it will take up to 2 hours to complete all study procedures.
This is an investigational study.
Up to 21 people will take part in this study at M. D. Anderson.
Type d'étude
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Genetic counselors: Board-eligible or board-certified genetic counselor
- Genetic counseling students: Currently enrolled and in good standing in an accredited genetic counseling degree program
- 18 years of age or older
Exclusion Criteria:
1. Non-English speaking
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Virtual Reality
Board-eligible or board-certified genetic counselors and students evaluate a virtual reality-based intervention using questionnaires and physiological measurements.
|
Questionnaires completed before and after viewing virtual reality scenes, taking about 30 minutes to complete.
Autres noms:
Small sensors applied to skin will measure heart rate and sweat amounts while participants view a virtual reality scene.
Prototype virtual reality application that demonstrates a provider-patient communication scenario commonly encountered in genetic counseling for hereditary cancers.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Proof of concept for Virtual Reality (VR) Technology as Training Method About Hereditary cancer risk and genetic testing
Délai: 2 hours
|
Proof of concept for VR application established if VR prototype successfully evokes a sense of presence and co-presence (measured by the PQ and CPQ questionnaires, respectively).
Responses to the PQ and CPQ given on a 7-point scale, with higher scores indicating higher degrees of presence and co-presence where mean scores above 4 considered high degree of presence and co-presence.
|
2 hours
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Susan Peterson, PHD, MPH, M.D. Anderson Cancer Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2009-0456
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .