Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management

NCT04992598 | Withdrawn

• 1 other identifier: 2021-02-CHRMT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

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.

Conditions

Shoulder Dislocation

Keywords

Hypnosis

Outcome Measures

Primary Outcomes (1)

• Analgesic consumption

  Calculated as the equal dose of morphine

  Day 1

Secondary Outcomes (7)

• Dose of sedative drug

  Day 1

• Patients'satisfaction

  Day 1

• Practitioners'satisfaction

  Day 1

• Number of attempts for reduction

  Day 1

• Length of stay

  Day 1

Study Arms (2)

Hypnosis group

EXPERIMENTAL

Other: Hypnosis session; Procedure: Reduction

Control group

PLACEBO COMPARATOR

Procedure: Reduction

Interventions

Hypnosis session OTHER

Hypnosis session will precede therapeutic strategies and reduction

Hypnosis group

Reduction PROCEDURE

All dislocation would be reduced Under adequate analgesia and sufficient sedation. All methods for reduction can be used.

Control group; Hypnosis group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (7)

CHR Fleyriat- Hôpital de Bourg en Bresse

Bourg-en-Bresse, Ain, 01000, France

Location

Centre Hospitalier Lucien Hussel

Vienne, Isère, 38209, France

Location

CHR Metz Thionville

Metz, Moselle, 57085, France

Location

Hôpital Robert Pax

Sarreguemines, Moselle, 57200, France

Location

Centre Hospitalier Saint Luc Saint Joseph

Lyon, Rhône, 69007, France

Location

Groupement hospitalier Sud-Hôpital Lyon Sud

Lyon, Rhône, 69495, France

Location

Hôpital Nord-Ouest Villefranche sur Saône

Villefranche-sur-Saône, Rhône, 69655, France

Location

Related Publications (1)

• Tinelli M, Guler N, Goetz C, Aim P, Marchionni S, Ouamara N, Cipolat L, Demarquet M, Seris E, Moreau A, Durand G, Douplat M, Lavignon JP, Hingray C, Abensur Vuillaume L. Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol. BMJ Open. 2022 Dec 7;12(12):e062278. doi: 10.1136/bmjopen-2022-062278.

  PMID: 36600368 DERIVED

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: June 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

FR (7)