Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management (HYPSEM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Other: Hypnosis session; Procedure: Reduction

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laure Abensur Vuillaume, MD; Phone Number: 0033 387553620; Email: l.abensurvuillaume@chr-metz-thionville.fr
• Study Contact Backup: Name: Nazmine Guler, MD; Email: n.guler@chr-metz-thionville.fr

Study Locations

• France
  • Ain
    • Bourg-en-Bresse, Ain, France, 01000
      • CHR Fleyriat- Hôpital de Bourg en Bresse
      • Contact: Marine Demarquet, MD
  • Isère
    • Vienne, Isère, France, 38209
      • Centre Hospitalier Lucien Hussel
      • Contact: Alexia Moreau, MD
  • Moselle
    • Metz, Moselle, France, 57085
      • CHR Metz Thionville
      • Contact: Nadia Ouamara; Phone Number: 0033 387557752; Email: n.ouamara@chr-metz-thionville.fr
      • Contact: Sandra Marchionni; Phone Number: 0033 387557750; Email: s.marchionni@chr-metz-thionville.fr
    • Sarreguemines, Moselle, France, 57200
      • Hôpital Robert Pax
      • Contact: Emmanuelle Seris, MD; Email: Emmanuelle.seris@ch-sarreguemines.fr
  • Rhône
    • Lyon, Rhône, France, 69007
      • Centre Hospitalier Saint Luc Saint Joseph
      • Contact: Jean Pierre Lavignon, MD; Email: jplavignon@ch-st-joseph-st-luc-lyon.fr
    • Lyon, Rhône, France, 69495
      • Groupement hospitalier Sud-Hôpital Lyon Sud
      • Contact: Marion Douplat, MD; Email: marion.douplat@chu-lyon.fr
    • Villefranche-sur-Saône, Rhône, France, 69655
      • Hôpital Nord-Ouest Villefranche sur Saône
      • Contact: Guillaume Durand, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hypnosis
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: 2021-02-CHRMT

Drug and device information, study documents

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