Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies
NCT ID: NCT03641859
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2018-08-23
2021-10-27
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Local anesthesia
The study population will consist of consecutive pre-screened patients when they arrive at the emergency department at the level of the host nurse. The emergency physician who will be in charge of the patient gives the patient the information form and ensures the absence of contraindication, responds to the patient's questions and collects his free, informed and express consent.
Once the patient is included, the group (with or without virtual reality) of the patient's participation in the study will be notified by the reception nurse and emergency referral:
\- Arm 1 (usual care): the procedure of care will be the same as usual.
No interventions assigned to this group
local anesthesia + virtual reality
The study population will consist of consecutive pre-screened patients when they arrive at the emergency department at the level of the host nurse. The emergency physician who will be in charge of the patient gives the patient the information form and ensures the absence of contraindication, responds to the patient's questions and collects his free, informed and express consent.
Once the patient is included, the group (with or without virtual reality) of the patient's participation in the study will be notified by the reception nurse and emergency referral:
\- Arm 2 (intervention): local anesthesia + virtual reality
virtual reality
The 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).
Interventions
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virtual reality
The 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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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Stéphanie MARTEAU, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
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Groupe Hospitalier Paris Saint-Joseph
Paris, , France
Countries
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References
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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.
Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
Hoffman HG, Patterson DR, Soltani M, Teeley A, Miller W, Sharar SR. Virtual reality pain control during physical therapy range of motion exercises for a patient with multiple blunt force trauma injuries. Cyberpsychol Behav. 2009 Feb;12(1):47-9. doi: 10.1089/cpb.2008.0056.
Schneider SM, Workman ML. Virtual reality as a distraction intervention for older children receiving chemotherapy. Pediatr Nurs. 2000 Nov-Dec;26(6):593-7.
Miller KM, Wysocki T, Cassady JF Jr, Cancel D, Izenberg N. Validation of measures of parents' preoperative anxiety and anesthesia knowledge. Anesth Analg. 1999 Feb;88(2):251-7. doi: 10.1097/00000539-199902000-00005.
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
Other Identifiers
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URGENCES_RV
Identifier Type: -
Identifier Source: org_study_id
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