Clinical trial NCT03641859: Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies
Official title: Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies: Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: pain
anxiety
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Man and woman (age ≥ 18 years)
* Francophone
* Patient with medical insurance
* Patient with a wound requiring trunk or limb sutures
* Or male patient requiring an urinary catheter
* Patient with cutaneous and subcutaneous wounds (deep plane possible) but without repair of noble tissues (tendons or fasciae) with no limit on the number of points to be made (i.e. without impact on the main endpoint).

Exclusion Criteria:

* Patient with a wound or skin infection of the face
* Patients with nausea, vomiting, dizziness
* Patients with a history of neurological disorders with epilepsy
* Patient whose investigator judges that he can not wear a virtual reality helmet
* Patient under tutorship or curatorship
* Patient deprived of liberty
* Refusal to participate in the study.

Primary outcomes:
measure: Analogical visual scale on the pain felt during the treatment
timeFrame: 1 hour after the beginning of virtual reality
Secondary outcomes:
measure: Analogical visual scale evaluating the patient's anxiety during the treatment
timeFrame: 1 hour after the beginning of virtual reality
measure: Analogical visual scale of patient satisfaction and satisfaction questionnaire
timeFrame: 1 hour after the beginning of virtual reality
measure: Analogical visual scale evaluating anxiety and pain before and after the gesture according to the treatment group
timeFrame: 1 hour after the beginning of virtual reality and 1 hour before the end of virtual relaity
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Stéphanie MARTEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3.
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