Clinical trial NCT04992598: Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management
Official title: Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management in the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Shoulder Dislocation
Keywords: Hypnosis
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Analgesic consumption
timeFrame: Day 1
Secondary outcomes:
measure: Dose of sedative drug
timeFrame: Day 1
measure: Patients'satisfaction
timeFrame: Day 1
measure: Practitioners'satisfaction
timeFrame: Day 1
measure: Number of attempts for reduction
timeFrame: Day 1
measure: Length of stay
timeFrame: Day 1
measure: Method use for reduction
timeFrame: Day 1
measure: Adverse events
timeFrame: Day 1
Other outcomes:
Locations:
city: Bourg-en-Bresse
country: France
facility: CHR Fleyriat- Hôpital de Bourg en Bresse
state: Ain
city: Vienne
country: France
facility: Centre Hospitalier Lucien Hussel
state: Isère
city: Metz
country: France
facility: CHR Metz Thionville
state: Moselle
city: Sarreguemines
country: France
facility: Hôpital Robert Pax
state: Moselle
city: Lyon
country: France
facility: Centre Hospitalier Saint Luc Saint Joseph
state: Rhône
city: Lyon
country: France
facility: Groupement hospitalier Sud-Hôpital Lyon Sud
state: Rhône
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord-Ouest Villefranche sur Saône
state: Rhône
Study officials:
References: