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WithdrawnNCT04992598HYPSEMUpdated May 30, 2024

Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management

An interventional study of Hypnosis session and Reduction in Shoulder Dislocation, sponsored by Centre Hospitalier Régional Metz-Thionville. Withdrawn at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
departure of the study coordinating investigator
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Shoulder Dislocation

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Keywords

  • Hypnosis
03

In context

Shoulder Dislocation

105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.

Browse Shoulder Dislocation studies →

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Hypnosis group

    Other: Hypnosis session · Procedure: Reduction

  • Placebo comparator
    Control group

    Procedure: Reduction

Interventions

  • OtherHypnosis session

    Hypnosis session will precede therapeutic strategies and reduction

  • ProcedureReduction

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

06

What researchers measure

Primary outcomes

  1. Analgesic consumption

    Calculated as the equal dose of morphine

    Time frame: Day 1

Secondary outcomes

  1. Dose of sedative drug

    Dose of sedative drug

    Time frame: Day 1

  2. 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).

    Time frame: Day 1

  3. 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).

    Time frame: Day 1

  4. Number of attempts for reduction

    Number of attempts for reduction

    Time frame: Day 1

  5. Length of stay

    Length of stay in the emergency department

    Time frame: Day 1

  6. Method use for reduction

    Method use for reduction

    Time frame: Day 1

  7. Adverse events

    number of adverse events

    Time frame: Day 1

07

Study locations

7 sites
  • CHR Fleyriat- Hôpital de Bourg en Bresse
    Bourg-en-Bresse, Ain 01000, France
  • Centre Hospitalier Lucien Hussel
    Vienne, Isère 38209, France
  • CHR Metz Thionville
    Metz, Moselle 57085, France
  • Hôpital Robert Pax
    Sarreguemines, Moselle 57200, France
  • Centre Hospitalier Saint Luc Saint Joseph
    Lyon, Rhône 69007, France
  • Groupement hospitalier Sud-Hôpital Lyon Sud
    Lyon, Rhône 69495, France
  • Hôpital Nord-Ouest Villefranche sur Saône
    Villefranche-sur-Saône, Rhône 69655, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2024; primary completion for Jul 2024, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2021
First posted
Aug 5, 2021
StartEst.
Jun 1, 2024
Primary completionEst.
Jul 1, 2024
CompletionEst.
Aug 1, 2024
Last update
May 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04992598
Responsible party
Sponsor
First posted
Aug 5, 2021
Start date
Jun 1, 2024 (estimated)
Primary completion
Jul 1, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
May 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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