Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management

Not Applicable

Withdrawn

• Conditions: Shoulder Dislocation
• Interventions: Other: Hypnosis session; Procedure: Reduction

• Registration Number: NCT04992598
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Study Start: 2024-06-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis group	Hypnosis session	-
Hypnosis group	Reduction	-
Control group	Reduction	-

Primary Outcome Measures

Name	Time	Method
Analgesic consumption	Day 1	Calculated as the equal dose of morphine

Secondary Outcome Measures

Name	Time	Method
Dose of sedative drug	Day 1	Dose of sedative drug
Patients'satisfaction	Day 1	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).
Length of stay	Day 1	Length of stay in the emergency department
Method use for reduction	Day 1	Method use for reduction
Practitioners'satisfaction	Day 1	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).
Number of attempts for reduction	Day 1	Number of attempts for reduction
Adverse events	Day 1	number of adverse events

Trial Locations

Locations (7)

CHR Metz Thionville; 🇫🇷 Metz, Moselle, France

Centre Hospitalier Saint Luc Saint Joseph; 🇫🇷 Lyon, Rhône, France

Centre Hospitalier Lucien Hussel; 🇫🇷 Vienne, Isère, France

Groupement hospitalier Sud-Hôpital Lyon Sud; 🇫🇷 Lyon, Rhône, France

CHR Fleyriat- Hôpital de Bourg en Bresse; 🇫🇷 Bourg-en-Bresse, Ain, France

Hôpital Robert Pax; 🇫🇷 Sarreguemines, Moselle, France

Hôpital Nord-Ouest Villefranche sur Saône; 🇫🇷 Villefranche-sur-Saône, Rhône, France