- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01570725
Virtual Reality to Reduce Anxiety in Ambulatory Surgical Operations (VRSurg)
A Portable Virtual Reality System as an Alternative Medical Treatment to Reduce Anxiety in Ambulatory Surgical Operations: a Randomized Controlled Study
Background. Preoperative anxiety is a common problem for patients who undergo surgical operations, being often associated with a number of negative behaviours during and after the surgical experience. Since drug treatments alone have frequently proved to be inadequate to reduce stress and anxiety in surgical contexts, in the last decades there has been an increased interest in non invasive complementary and alternative medical therapies (CAM), including music, relaxation, guided imagery, hypnosis, etc. that reduce pain and tension during pre and post operative phases. Virtual reality can be considered an innovative form of e-health-based CAM therapy having gained recognition as a means of attenuating pain during medical procedures. VR reduces distress and pain perception by providing a particularly intense form of immersive distraction that taxes the patient's limited attention capacity, resulting in the withdrawal of attention from the real, noxious, external stimulus with a subsequent reduction in pain and stress.
Objective. The aim of this study is to test the efficacy of a small, portable and immersive virtual reality system to reduce anxiety in a sample of patients who underwent ambulatory surgical operations under local or regional anaesthesia.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Mexico City, Mexique
- Regional Hospital No. 25 of the IMSS
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- all patients who undergo ambulatory surgical operations and sign informed consent
Exclusion Criteria:
- death or blind patients
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 1
Virtual reality exposure to a relaxing virtual environment.
The virtual experience will be provided using immersive equipment.
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The Green Valley, a non interactive, relaxing environment showing a mountain landscape around a calm lake is presented to the patient together with the relaxing music and soft sounds (birds' songs, the water flowing, etc). Having the impression of walking around the lake, patients can observe the nature and virtually seat on a comfortable deck chair, in order to become easily relaxed. Patients were exposed to the virtual environment for the entire length of the operation. |
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Expérimental: 2
Exposure to relaxing music.
The music will be selected between classical music tunes.
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A relaxing music and nature sounds have been used to provide a calm atmosphere and reduce stress.
In the Music group it was provided to the patients through earphones with no visual stimulation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Psychological measure of anxiety (VAS-A)
Délai: One day before operation; one hour after operation; one week after operation
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Change from baseline in the level of anxiety
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One day before operation; one hour after operation; one week after operation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physiological parameter (heart rate)
Délai: One day before operation; one hour after operation; one week after operation
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Change from baseline in the heart rate
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One day before operation; one hour after operation; one week after operation
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Giuseppe Riva, PHD, Istituto Auxologico Italiano
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- VR01
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