Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management

Shoulder Dislocation Clinical Trial

— HYPSEM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04992598
• Other study ID #: 2021-02-CHRMT
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

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.

Locations

Country	Name	City	State
France	CHR Fleyriat- Hôpital de Bourg en Bresse	Bourg-en-Bresse	Ain
France	Centre Hospitalier Saint Luc Saint Joseph	Lyon	Rhône
France	Groupement hospitalier Sud-Hôpital Lyon Sud	Lyon	Rhône
France	CHR Metz Thionville	Metz	Moselle
France	Hôpital Robert Pax	Sarreguemines	Moselle
France	Centre Hospitalier Lucien Hussel	Vienne	Isère
France	Hôpital Nord-Ouest Villefranche sur Saône	Villefranche-sur-Saône	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic consumption	Calculated as the equal dose of morphine	Day 1
Secondary	Dose of sedative drug	Dose of sedative drug	Day 1
Secondary	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
Secondary	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
Secondary	Number of attempts for reduction	Number of attempts for reduction	Day 1
Secondary	Length of stay	Length of stay in the emergency department	Day 1
Secondary	Method use for reduction	Method use for reduction	Day 1
Secondary	Adverse events	number of adverse events	Day 1