Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department – a multicentre, randomised, controlled study protocol
Introduction Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study...
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e062278.full |
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| author | Marion Douplat Guillaume Durand Coraline Hingray Christophe Goetz Nadia Ouamara Sandra Marchionni Marine Demarquet Marion Tinelli Nazmine Guler Philippe Aim Lauriane Cipolat Emmanuelle Seris Alexia Moreau Jean-Pierre Lavignon Laure Abensur Vuillaume |
| author_facet | Marion Douplat Guillaume Durand Coraline Hingray Christophe Goetz Nadia Ouamara Sandra Marchionni Marine Demarquet Marion Tinelli Nazmine Guler Philippe Aim Lauriane Cipolat Emmanuelle Seris Alexia Moreau Jean-Pierre Lavignon Laure Abensur Vuillaume |
| author_sort | Marion Douplat |
| collection | DOAJ |
| description | Introduction Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study is to show that reduction under hypnosis is associated with a decrease in the use of analgesic compared with usual care.Methods and analysis We will conduct an interventional, controlled, multicentre, randomised study. A total of 44 patients with shoulder dislocation will be randomised in two groups: the hypnosis group (N=22) and the usual care group (N=22). The primary endpoint will be the comparison of morphine equivalent analgesic consumption during a shoulder dislocation reduction manoeuvre. Secondary endpoints will include haemodynamic parameters monitoring, patient and practitioner satisfaction using a Likert scale, use of coanalgesic or sedative drugs, number of reduction attempts and time spent at ED. Adverse events will be recorded. Statistical analysis will include parametric tests, multivariate linear regression and descriptive statistics.Ethics and dissemination This study has received ethics approval from the Comité de Protection des Personnes of Sud-Est IV on 03/11/2021 (ANSM informed on 19 November 2021). The results will be published in scientific articles and communicated in national and international conferences.Trial registration number ClinicalTrial.gov: NCT04992598; National Clinical trial no ID RCB : 2021-A01382-39 |
| format | Article |
| id | doaj-art-8988401da50948cbbf329056c6cdca3d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8988401da50948cbbf329056c6cdca3d2025-08-20T03:52:38ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-062278Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department – a multicentre, randomised, controlled study protocolMarion Douplat0Guillaume Durand1Coraline Hingray2Christophe Goetz3Nadia Ouamara4Sandra Marchionni5Marine Demarquet6Marion Tinelli7Nazmine Guler8Philippe Aim9Lauriane Cipolat10Emmanuelle Seris11Alexia Moreau12Jean-Pierre Lavignon13Laure Abensur Vuillaume14Hôpital Lyon Sud, Service d’Accueil des Urgences, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, FranceCH Villefranche sur saones, Villefranche sur saones, FranceNeurology Department, CHRU de Nancy, Nancy, Lorraine, FranceClinical Research Support Unit, CHR Metz-Thionville, Metz, FrancePsychiatre Libéral, Paris, FranceClinical Research Support Unit, Regional Hospital Centre Metz-Thionville, Metz, FranceCentre Hospitalier Fleyriat, Service d’Accueil des Urgences, Centre Hospitalier de Bourg-en-Bresse, Bourg-en-Bresse, Rhône-Alpes, FranceFaculté de médecine, Université de Lyon, Lyon, FranceEmergency Department, CHR Metz-Thionville, Metz, FrancePsychiatre Libéral, Paris, FranceEmergency Department, CHR Metz-Thionville, Metz, FranceCH Sargueminnes, Sargueminnes, FranceCH Vienne, Vienne, FranceSaint Joseph Saint Luc Hospital Anesthesia-Resuscitation, Lyon, FranceEmergency Department, CHR Metz-Thionville, Metz, FranceIntroduction Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study is to show that reduction under hypnosis is associated with a decrease in the use of analgesic compared with usual care.Methods and analysis We will conduct an interventional, controlled, multicentre, randomised study. A total of 44 patients with shoulder dislocation will be randomised in two groups: the hypnosis group (N=22) and the usual care group (N=22). The primary endpoint will be the comparison of morphine equivalent analgesic consumption during a shoulder dislocation reduction manoeuvre. Secondary endpoints will include haemodynamic parameters monitoring, patient and practitioner satisfaction using a Likert scale, use of coanalgesic or sedative drugs, number of reduction attempts and time spent at ED. Adverse events will be recorded. Statistical analysis will include parametric tests, multivariate linear regression and descriptive statistics.Ethics and dissemination This study has received ethics approval from the Comité de Protection des Personnes of Sud-Est IV on 03/11/2021 (ANSM informed on 19 November 2021). The results will be published in scientific articles and communicated in national and international conferences.Trial registration number ClinicalTrial.gov: NCT04992598; National Clinical trial no ID RCB : 2021-A01382-39https://bmjopen.bmj.com/content/12/12/e062278.full |
| spellingShingle | Marion Douplat Guillaume Durand Coraline Hingray Christophe Goetz Nadia Ouamara Sandra Marchionni Marine Demarquet Marion Tinelli Nazmine Guler Philippe Aim Lauriane Cipolat Emmanuelle Seris Alexia Moreau Jean-Pierre Lavignon Laure Abensur Vuillaume Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department – a multicentre, randomised, controlled study protocol BMJ Open |
| title | Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department – a multicentre, randomised, controlled study protocol |
| title_full | Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department – a multicentre, randomised, controlled study protocol |
| title_fullStr | Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department – a multicentre, randomised, controlled study protocol |
| title_full_unstemmed | Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department – a multicentre, randomised, controlled study protocol |
| title_short | Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department – a multicentre, randomised, controlled study protocol |
| title_sort | study protocol hypnosis versus standard care for shoulder dislocation reduction in the emergency department a multicentre randomised controlled study protocol |
| url | https://bmjopen.bmj.com/content/12/12/e062278.full |
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