Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management (HYPSEM)
Primary Purpose
Shoulder Dislocation
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis session
Reduction
Sponsored by
About this trial
This is an interventional diagnostic trial for Shoulder Dislocation focused on measuring Hypnosis
Eligibility Criteria
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
Sites / Locations
- CHR Fleyriat- Hôpital de Bourg en Bresse
- Centre Hospitalier Lucien Hussel
- CHR Metz Thionville
- Hôpital Robert Pax
- Centre Hospitalier Saint Luc Saint Joseph
- Groupement hospitalier Sud-Hôpital Lyon Sud
- Hôpital Nord-Ouest Villefranche sur Saône
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hypnosis group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Analgesic consumption
Calculated as the equal dose of morphine
Secondary Outcome Measures
Dose of sedative drug
Dose of sedative drug
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).
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).
Number of attempts for reduction
Number of attempts for reduction
Length of stay
Length of stay in the emergency department
Method use for reduction
Method use for reduction
Adverse events
number of adverse events
Full Information
NCT ID
NCT04992598
First Posted
July 28, 2021
Last Updated
September 28, 2023
Sponsor
Centre Hospitalier Régional Metz-Thionville
1. Study Identification
Unique Protocol Identification Number
NCT04992598
Brief Title
Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management
Acronym
HYPSEM
Official Title
Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
Hypnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypnosis group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Hypnosis session
Intervention Description
Hypnosis session will precede therapeutic strategies and reduction
Intervention Type
Procedure
Intervention Name(s)
Reduction
Intervention Description
All dislocation would be reduced Under adequate analgesia and sufficient sedation. All methods for reduction can be used.
Primary Outcome Measure Information:
Title
Analgesic consumption
Description
Calculated as the equal dose of morphine
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Dose of sedative drug
Description
Dose of sedative drug
Time Frame
Day 1
Title
Patients'satisfaction
Description
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
Title
Practitioners'satisfaction
Description
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
Title
Number of attempts for reduction
Description
Number of attempts for reduction
Time Frame
Day 1
Title
Length of stay
Description
Length of stay in the emergency department
Time Frame
Day 1
Title
Method use for reduction
Description
Method use for reduction
Time Frame
Day 1
Title
Adverse events
Description
number of adverse events
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Abensur Vuillaume, MD
Phone
387553620
Ext
0033
Email
l.abensurvuillaume@chr-metz-thionville.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nazmine Guler, MD
Email
n.guler@chr-metz-thionville.fr
Facility Information:
Facility Name
CHR Fleyriat- Hôpital de Bourg en Bresse
City
Bourg-en-Bresse
State/Province
Ain
ZIP/Postal Code
01000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Demarquet, MD
Facility Name
Centre Hospitalier Lucien Hussel
City
Vienne
State/Province
Isère
ZIP/Postal Code
38209
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexia Moreau, MD
Facility Name
CHR Metz Thionville
City
Metz
State/Province
Moselle
ZIP/Postal Code
57085
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Ouamara
Phone
387557752
Ext
0033
Email
n.ouamara@chr-metz-thionville.fr
First Name & Middle Initial & Last Name & Degree
Sandra Marchionni
Phone
387557750
Ext
0033
Email
s.marchionni@chr-metz-thionville.fr
Facility Name
Hôpital Robert Pax
City
Sarreguemines
State/Province
Moselle
ZIP/Postal Code
57200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Seris, MD
Email
Emmanuelle.seris@ch-sarreguemines.fr
Facility Name
Centre Hospitalier Saint Luc Saint Joseph
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69007
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Pierre Lavignon, MD
Email
jplavignon@ch-st-joseph-st-luc-lyon.fr
Facility Name
Groupement hospitalier Sud-Hôpital Lyon Sud
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69495
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Douplat, MD
Email
marion.douplat@chu-lyon.fr
Facility Name
Hôpital Nord-Ouest Villefranche sur Saône
City
Villefranche-sur-Saône
State/Province
Rhône
ZIP/Postal Code
69655
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Durand, MD
12. IPD Sharing Statement
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Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management
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