Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management

Study Overview
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Brief Summary
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The effectiveness of hypnosis for reducing pain was evaluated in various medical specialities. However, only few studies have demonstrated the efficacy of hypnosis for the management of pain in the emergency medicine. Anteromedial dislocation is a very common Reason for admission in emergency department. Many methods for reduction have been described but there is no consensus on the optimum technique or sedation procedures. Some pain medication and tranquilizers used during a shoulder dislocation management include hemodynamic, respiratory and behavioral adverse effects with the requirement of strengthened surveillance. Hypnosis could provide to reduce sedative and analgesic use during the reduction of anteromedial dislocation. The main objective of this study is to evaluate the efficacy of a hypnosis session for reducing the consumption of analgesic in patient throughout a reduction of shoulder dislocation. The investigators also examine the effect of hypnosis on hemodynamic parameters, patient's pain, patient and practitioner satisfaction, sedative consumption, number of attempts for reduction and length of stay in the emergency department.

Official Title
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Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management in the Emergency Department

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Other: Hypnosis session
* Procedure: Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years and over, Checked into ED for an anterior shoulder dislocation suspected by clinical examination and confirmed by radiography, Had given oral consent to participate in the study Are affiliated or be a recipient of a social security plan. A staff member (nurse, nurse's aide, or physician) trained in hypnosis is available at the patient admission time. Exclusion Criteria: Patient showing up with a shoulder fracture on x-ray. Patient presenting a shoulder prosthesis. Patient with recurrent dislocations. Patient who does not speak or understand French language. Patient with cognitive dysfunction. Patient with a psychiatric history of psychosis. Patient who is deaf or hard of hearing. Patient under legal protection (guardianship, curatorship). Pregnant women Patient who already benefited of a pre-hospital reduction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis group<br> | Other: Hypnosis session<br>* Hypnosis session will precede therapeutic strategies and reduction<br>Procedure: Reduction<br>* All dislocation would be reduced Under adequate analgesia and sufficient sedation. All methods for reduction can be used.<br>|
| Placebo Comparator: Control group<br> | Procedure: Reduction<br>* All dislocation would be reduced Under adequate analgesia and sufficient sedation. All methods for reduction can be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption | Calculated as the equal dose of morphine | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of sedative drug | Dose of sedative drug | Day 1 | 
| Patients'satisfaction | Patients'satisfaction was assessed with a Likert scale after reduction. The satisfaction was scored on 5-point Likert scale, ranging from 1 to 5 (with 1=excellent and 5=catastrophic). | Day 1 | 
| Practitioners'satisfaction | Practitioners'satisfaction was assessed with a Likert scale after reduction. The satisfaction was scored on 5-point Likert scale, ranging from 1 to 5 ( with 1=excellent and 5=catastrophic). | Day 1 | 
| Number of attempts for reduction | Number of attempts for reduction | Day 1 | 
| Length of stay | Length of stay in the emergency department | Day 1 | 
| Method use for reduction | Method use for reduction | Day 1 | 
| Adverse events | number of adverse events | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnosis