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

C

Centre Hospitalier Régional Metz-Thionville

Status

Withdrawn

Conditions

Shoulder Dislocation

Treatments

Procedure: Reduction
Other: Hypnosis session

Study type

Interventional

Funder types

Other

Identifiers

NCT04992598
2021-02-CHRMT

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups, including a placebo group

Hypnosis group
Experimental group
Treatment:
Procedure: Reduction
Other: Hypnosis session
Control group
Placebo Comparator group
Treatment:
Procedure: Reduction

Trial contacts and locations

7

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Central trial contact

Laure Abensur Vuillaume, MD; Nazmine Guler, MD

Data sourced from clinicaltrials.gov

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