Clinical Trials Directory

Trials / Completed

CompletedNCT03641859

Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies

Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies: Randomized Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
71 (actual)
Sponsor
Fondation Hôpital Saint-Joseph · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A large number of patients presenting to the emergency department will have an invasive or potentially painful treatment (suture, urinary catheterization, reduction of dislocation or fracture). This care is a source of pain and anxiety for patients. Since 1998, the management of pain is a public health priority in France. Law No. 2002-3003 of 4 March 2002 on the rights of the sick and the quality of the health system has made pain management a right: "Everyone has the right to receive care to relieve his pain. This must be in all circumstances prevented, evaluated, taken into account and treated ". In emergency departments, the use of antalgic drug treatments and local anesthetics is systematic.

Detailed description

Other techniques to create diversions proposed in the recommendations of the French Society of Emergency Medicine for the management of wounds in emergencies can be used to improve the experience of patients: the use speech during the gesture or certain forms of hypnosis. Pain and anxiety are two important factors to integrate to improve the management of patients in emergencies. To improve pain and anxiety, distraction is a technique that can be used. Virtual reality is a distraction technique not yet frequently used but studied. It combines the visual and the auditory allowing immersion in a virtual world thanks to a helmet retranscribing a three-dimensional image. The diversion of attention through the use of virtual reality allows the patient to immerse themselves in a fictional environment through a mask on the eyes inhibiting the vision of the outside world and a headphone reducing external sounds and reinforcing the mechanism of 'immersion. The use of the virtual reality headset has already shown benefits during pain care in burn patients and children. The virtual reality headset has not yet been studied as a distraction tool for invasive and potentially painful care in emergencies.

Conditions

Interventions

TypeNameDescription
DEVICEvirtual realityThe virtual reality headset can be used for 45 minutes with the need to pause for 5 minutes if the gesture lasts longer. The VR sequence will be complete when the end of the programmed time is reached to preserve the patient's immersion. The patient will be able to see the final sequence at the end of the gesture in order to get used to the real world again. The programs and their durations will be adjusted to the duration of the gesture concerned. Regarding the pain, anxiety and satisfaction visual analogue scales, they will be performed just after the removal of the VR helmet. Virtual reality videos are from Healthy Mind® software. The videos are contemplative with three kinds of relaxing landscapes accompanied by a sound universe specifically composed to relax the patient. The patient can choose one of three interactive worlds (an Asian garden, a forest or a mountain).

Timeline

Start date
2018-08-23
Primary completion
2021-08-23
Completion
2021-10-27
First posted
2018-08-22
Last updated
2022-03-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03641859. Inclusion in this directory is not an endorsement.