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

NCT03641859 | Completed

• 1 other identifier: URGENCES_RV
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality

Keywords

pain; anxiety

Outcome Measures

Primary Outcomes (1)

• Analogical visual scale on the pain felt during the treatment

  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)

  1 hour after the beginning of virtual reality

Secondary Outcomes (3)

• Analogical visual scale evaluating the patient's anxiety during the treatment

  1 hour after the beginning of virtual reality

• Analogical visual scale of patient satisfaction and satisfaction questionnaire

  1 hour after the beginning of virtual reality

• Analogical visual scale evaluating anxiety and pain before and after the gesture according to the treatment group

  1 hour after the beginning of virtual reality and 1 hour before the end of virtual relaity

Study Arms (2)

Local anesthesia

NO INTERVENTION

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.

local anesthesia + virtual reality

EXPERIMENTAL

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

Interventions

virtual reality DEVICE

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).

local anesthesia + virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (6)

• 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.

  PMID: 24108531 RESULT

• 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.

  PMID: 28356241 RESULT

• 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.

  PMID: 19018695 RESULT

• Schneider SM, Workman ML. Virtual reality as a distraction intervention for older children receiving chemotherapy. Pediatr Nurs. 2000 Nov-Dec;26(6):593-7.

  PMID: 12026359 RESULT

• 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.

  PMID: 9972736 RESULT

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 RESULT

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Stéphanie MARTEAU, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 22, 2018
• Study Start: August 23, 2018
• Primary Completion: August 23, 2021
• Study Completion: October 27, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

FR (1)