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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Anxiety
• Intervention / Treatment: Other: Administration of MEOPA as part of the care

Detailed Description

There is a definite interest in the management of patients' pre-hospital anxiety. The literature reports a strong association between anxiety, post-traumatic stress and chronic pain. A study conducted at SAMU 31 also found that anxiety on arrival at the emergency department was a negative factor in the treatment of pain. Anxiety can reduce the pain threshold and promote hyperalgesia.

The management of patient anxiety in pre-hospital offers interesting results in terms of analgesia and satisfaction of users of care and should not be neglected.

MEOPA has recently been available in SMUR vehicles (emergency and resuscitation mobile service) at SAMU 31 (urgent medical assistance service); its availability can lead teams to change their practices. More and more emphasis is placed on the importance of positive communication and comfort for which MEOPA, with its conscious sedating effect, could be a facilitating factor.

The aim of our study is to evaluate the level of anxiety of patients treated by SMUR teams in Toulouse and receiving MEOPA following the usual indications for pain-induced pain or pain alleviation.

This is a pilot study, which focuses on the assessment of anxiety in patients treated in pre-hospital care by SMUR Toulouse and receiving MEOPA as part of their care. No data exists in the literature on this subject.

This descriptive study based on qualitative data collected by the FAS1 scale will provide us with the first data on this population. It does not change the usual management of the patient since only patients who must receive MEOPA following the usual indications for pain relief or pain-induced care will be included in the study

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital TOULOUSE

Participation Criteria

Eligibility Criteria

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

• 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)

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Patient in vital distress

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pain felt by the patient, evaluated by the numerical scale (EN), in connection with his anxiety	EN is a self-rated scale of pain: the patient rates his or her pain on a numeric scale from 0 (no pain) to 10 (maximum pain). The evaluation of the pain at the SAMU is carried out in routine at each support by the EN. For the purposes of this study, the investigators will find the value of the EN in the same temporality as the assessment of anxiety.	2 hours

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Vincent Bounes, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Emergency
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: RC31/18/0222; 2018-A01687-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No