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

• ClinicalTrials.gov Identifier: NCT03641859
• Recruitment Status: Completed
• First Posted: August 22, 2018
• Last Update Posted: March 31, 2022
• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Information provided by (Responsible Party): Groupe Hospitalier Paris Saint Joseph

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Virtual Reality	Device: virtual reality	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies: Randomized Trial
• Actual Study Start Date: August 23, 2018
• Actual Primary Completion Date: August 23, 2021
• Actual Study Completion Date: October 27, 2021

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 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.
Experimental: 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	Device: 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).

Outcome Measures

Primary Outcome Measures :

1. Analogical visual scale on the pain felt during the treatment [ Time Frame: 1 hour after the beginning of virtual reality ]
   Analogical visual scale on the pain felt during the treatment Analogical Visual Scale (EVA): a slider that allows the patient to self-assess the pain felt by a slider On the front of the ruler, is drawn a line or a pyramid on which the patient moves the cursor from the end "no pain" to the end "maximum pain imaginable" On the back of the slide, the caregiver reads the pain felt by the patient using a graduation in millimeters (from 0 to 100 mm)

Secondary Outcome Measures :

1. Analogical visual scale evaluating the patient's anxiety during the treatment [ Time Frame: 1 hour after the beginning of virtual reality ]
   Analogical visual scale evaluating the patient's anxiety during the treatment Analogical Visual Scale (EVA): a slider that allows the patient to self-assess the anxiety felt by a slider On the front of the ruler, is drawn a line or a pyramid on which the patient moves the cursor from the end "no anxiety" to the end "maximum anxiety" On the back of the slide, the caregiver reads the pain felt by the patient using a graduation in millimeters (from 0 to 100 mm)
2. Analogical visual scale of patient satisfaction and satisfaction questionnaire [ Time Frame: 1 hour after the beginning of virtual reality ]
   Analogical visual scale of patient satisfaction and satisfaction questionnaire Analogical Visual Scale (EVA): a slider that allows the patient to self-assess the pain felt by a slider On the front of the ruler, is drawn a line or a pyramid on which the patient moves the cursor from the end "not satisfied" to the end "very satisfied" On the back of the slide, the caregiver reads the pain felt by the patient using a graduation in millimeters (from 0 to 100 mm)
3. Analogical visual scale evaluating anxiety and pain before and after the gesture according to the treatment group [ Time Frame: 1 hour after the beginning of virtual reality and 1 hour before the end of virtual relaity ]
   Analogical visual scale evaluating anxiety and pain before and after the gesture according to the treatment group Analogical Visual Scale (EVA): a slider that allows the patient to self-assess the pain felt by a slider On the front of the ruler, is drawn a line or a pyramid on which the patient moves the cursor from the end "no pain/anxiety" to the end "maximum pain imaginable/maximum anxiety" On the back of the slide, the caregiver reads the pain felt by the patient using a graduation in millimeters (from 0 to 100 mm)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

France

Groupe Hospitalier Paris Saint-Joseph

Paris, France, 75014

Sponsors and Collaborators

Groupe Hospitalier Paris Saint Joseph

Investigators

• Principal Investigator: Stéphanie MARTEAU, MD; Groupe Hospitalier Paris Saint Joseph

More Information

Publications of Results:

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.

• Responsible Party: Groupe Hospitalier Paris Saint Joseph
• ClinicalTrials.gov Identifier: NCT03641859
• Other Study ID Numbers: URGENCES_RV
• First Posted: August 22, 2018
• Last Update Posted: March 31, 2022
• Last Verified: March 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Groupe Hospitalier Paris Saint Joseph:

pain; anxiety

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes