Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care

NCT03613155 | Unknown

• 2 other identifiers: RC31/18/02222018-A01687-48
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The emergency setting, frequently associated with pain and the feeling of loss of control, can cause anxiety in patients. Reaction anxiety may be an appropriate response to an emergency; Nevertheless, attention must be paid to the evaluation and management of the latter especially as anxiety and pain are closely linked.

Conditions

Pain; Anxiety

Keywords

Emergency

Outcome Measures

Primary Outcomes (1)

• The state of anxiety of the patient assessed by Face Anxiety Scale

  The state of anxiety of the patient assessed by FAS (face anxiety scale) self-assessment when supported by a SMUR team with MEOPA administration. The FAS, called the Anxiety Faces Scale, is a validated anxiety assessment scale that was originally developed in the context of Critical Care, Critical Care (ICU) management. The Faces Anxiety Scale is a valid single-item, self-report measure of state anxiety in intensive care patients that is easy to administer and imposes minimal respondent burden. It has the potential to be a useful instrument for the assessment of state anxiety by clinicians and for research into the reduction of anxiety in this vulnerable population.

  2 hours

Secondary Outcomes (1)

• The pain felt by the patient, evaluated by the numerical scale (EN), in connection with his anxiety

  2 hours

Interventions

Administration of MEOPA as part of the care OTHER

Patients should be managed by a SMUR team from Toulouse and benefit from MEOPA administration as part of their management, with a view to analgesia for a painful complaint or prevention of induced pain (for example during mobilization or venous route).

Eligibility Criteria

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

Study Population

Patient treated by the SMUR receiving MEOPA during pre-hospital care (in the usual indications for pain relief or pain-induced care)

You may qualify if:

• Patient over 18
• Patient supported by a SMUR team from Toulouse
• Patient receiving MEOPA during pre-hospital care (in the usual indications for pain relief or pain-induced care)
• Patient having given his non-opposition to participate in the study

You may not qualify if:

• Any patient with a contraindication to MEOPA:
• Patient requiring pure oxygen ventilation
• Intracranial hypertension
• Any alteration of the state of consciousness preventing the patient's cooperation
• Traumatic brain injury
• Pneumothorax
• Emphysema bubbles
• Gas embolism
• Diving accident
• Abdominal gas distension
• Patient who received an ophthalmic gas for ocular surgery less than three months old
• Known and unsubstituted vitamin B12 deficiency
• Patient under legal protection
• Refusal of the patient to participate in the study
• Barrier of the language or alteration of the communication

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Emergencies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Vincent Bounes, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 2, 2018
• Study Start: September 4, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)