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

Primary Purpose

Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
virtual reality
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Virtual Reality focused on measuring pain, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Groupe Hospitalier Paris Saint-Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Local anesthesia

local anesthesia + virtual reality

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Analogical visual scale evaluating the patient's anxiety during the treatment
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)
Analogical visual scale of patient satisfaction and satisfaction questionnaire
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)
Analogical visual scale evaluating anxiety and pain before and after the gesture according to the treatment group
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)

Full Information

First Posted
August 13, 2018
Last Updated
March 30, 2022
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT03641859
Brief Title
Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies
Acronym
URGENCES_RV
Official Title
Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies: Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
August 23, 2021 (Actual)
Study Completion Date
October 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality
Keywords
pain, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local anesthesia
Arm Type
No Intervention
Arm Description
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.
Arm Title
local anesthesia + virtual reality
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
virtual reality
Intervention Description
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).
Primary Outcome Measure Information:
Title
Analogical visual scale on the pain felt during the treatment
Description
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)
Time Frame
1 hour after the beginning of virtual reality
Secondary Outcome Measure Information:
Title
Analogical visual scale evaluating the patient's anxiety during the treatment
Description
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)
Time Frame
1 hour after the beginning of virtual reality
Title
Analogical visual scale of patient satisfaction and satisfaction questionnaire
Description
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)
Time Frame
1 hour after the beginning of virtual reality
Title
Analogical visual scale evaluating anxiety and pain before and after the gesture according to the treatment group
Description
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)
Time Frame
1 hour after the beginning of virtual reality and 1 hour before the end of virtual relaity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie MARTEAU, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24108531
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.
Results Reference
result
PubMed Identifier
28356241
Citation
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.
Results Reference
result
PubMed Identifier
19018695
Citation
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.
Results Reference
result
PubMed Identifier
12026359
Citation
Schneider SM, Workman ML. Virtual reality as a distraction intervention for older children receiving chemotherapy. Pediatr Nurs. 2000 Nov-Dec;26(6):593-7.
Results Reference
result
PubMed Identifier
9972736
Citation
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.
Results Reference
result
PubMed Identifier
4139420
Citation
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
Results Reference
result

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

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