AutomedicationFrancoV1, Main, Exploration, bibRecord, 000825

Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial.

Identifieur interne : 000825 ( Main/Exploration ); précédent : 000824; suivant : 000826

Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial.

Auteurs : Cédric Gil-Jardiné [France] ; Samantha Al Joboory [France] ; Juliane Tortes Saint Jammes [France] ; Guillaume Durand [France] ; Régis Ribéreau-Gayon [France] ; Michel Galinski [France] ; Louis-Rachid Salmi [France] ; Philippe Revel [France] ; Cyril Alexandre Régis [France] ; Guillaume Valdenaire [France] ; Emmanuel Poulet [France] ; Karim Tazarourte [France] ; Emmanuel Lagarde [France]

Source :

Trials [ 1745-6215 ] ; 2018.

RBID : pubmed:30314512

Descripteurs français

KwdFr :
- Commotion de l'encéphale (diagnostic), Commotion de l'encéphale (physiopathologie), Commotion de l'encéphale (psychologie), Commotion de l'encéphale (thérapie), Désensibilisation et reprogrammation par mouvements oculaires (méthodes), Essais contrôlés randomisés comme sujet (MeSH), Facteurs de risque (MeSH), Facteurs temps (MeSH), France (MeSH), Humains (MeSH), Mouvements oculaires (MeSH), Résultat thérapeutique (MeSH), Service hospitalier d'urgences (MeSH), Syndrome post-commotionnel (diagnostic), Syndrome post-commotionnel (physiopathologie), Syndrome post-commotionnel (prévention et contrôle), Syndrome post-commotionnel (psychologie), Études multicentriques comme sujet (MeSH).
MESH :
- diagnostic : Commotion de l'encéphale, Syndrome post-commotionnel.
- méthodes : Désensibilisation et reprogrammation par mouvements oculaires.
- physiopathologie : Commotion de l'encéphale, Syndrome post-commotionnel.
- prévention et contrôle : Syndrome post-commotionnel.
- psychologie : Commotion de l'encéphale, Syndrome post-commotionnel.
- thérapie : Commotion de l'encéphale.
- Essais contrôlés randomisés comme sujet, Facteurs de risque, Facteurs temps, France, Humains, Mouvements oculaires, Résultat thérapeutique, Service hospitalier d'urgences, Études multicentriques comme sujet.
Wicri :
- geographic : France.

English descriptors

KwdEn :
- Brain Concussion (diagnosis), Brain Concussion (physiopathology), Brain Concussion (psychology), Brain Concussion (therapy), Emergency Service, Hospital (MeSH), Eye Movement Desensitization Reprocessing (methods), Eye Movements (MeSH), France (MeSH), Humans (MeSH), Multicenter Studies as Topic (MeSH), Post-Concussion Syndrome (diagnosis), Post-Concussion Syndrome (physiopathology), Post-Concussion Syndrome (prevention & control), Post-Concussion Syndrome (psychology), Randomized Controlled Trials as Topic (MeSH), Risk Factors (MeSH), Time Factors (MeSH), Treatment Outcome (MeSH).
MESH :
- geographic : France.
- diagnosis : Brain Concussion, Post-Concussion Syndrome.
- methods : Eye Movement Desensitization Reprocessing.
- physiopathology : Brain Concussion, Post-Concussion Syndrome.
- prevention & control : Post-Concussion Syndrome.
- psychology : Brain Concussion, Post-Concussion Syndrome.
- therapy : Brain Concussion.
- Emergency Service, Hospital, Eye Movements, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Risk Factors, Time Factors, Treatment Outcome.

Abstract

BACKGROUND

Recent data suggest that 10-20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decline in quality of life. A preliminary randomized control trial suggested that this condition may be induced by the stress experienced during the event or emergency room (ER) stay and can be prevented in up to 75% of patients with a single, early, short eye movement desensitization and reprocessing (EMDR) psychotherapeutic session delivered in the ER. The protocol of the SOFTER 3 study was designed to compare the impact on 3-month PCLS of early EMDR intervention and usual care in patients presenting at the ER. Secondary outcomes included 3-month post-traumatic stress disorder, 12-month PCLS, self-reported stress at the ER, self-assessed recovery expectation at discharge and 3 months, and self-reported chronic pain at discharge and 3 months.

METHODS

This is a two-group, open-label, multicenter, comparative, randomized controlled trial with 3- and 12-month phone follow-up for reports of persisting symptoms (PCLS and post-traumatic stress disorder). Those eligible for inclusion were adults (≥18 years old) presenting at the ER departments of the University Hospital of Bordeaux and University Hospital of Lyon, assessed as being at high risk of PCLS using a three-item scoring rule. The intervention groups were a (1) EMDR Recent Traumatic Episode Protocol intervention performed by a trained psychologist during ER stay or (2) usual care. The number of patients to be enrolled in each group was 223 to evidence a 15% decrease in PCLS prevalence in the EMDR group.

DISCUSSION

In 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge.

TRIAL REGISTRATION

Clinical Trials. NCT03400813 . Registered 17 January 2018 - retrospectively registered.

DOI: 10.1186/s13063-018-2902-2
PubMed: 30314512
PubMed Central: PMC6186089

Affiliations:

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 000690
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Le document en format XML

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<author><name sortKey="Jammes, Juliane Tortes Saint" sort="Jammes, Juliane Tortes Saint" uniqKey="Jammes J" first="Juliane Tortes Saint" last="Jammes">Juliane Tortes Saint Jammes</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Emergency Medicine, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon</wicri:regionArea>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:affiliation>University Hospital, Claude Bernard University, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>University Hospital, Claude Bernard University, Lyon</wicri:regionArea>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ribereau Gayon, Regis" sort="Ribereau Gayon, Regis" uniqKey="Ribereau Gayon R" first="Régis" last="Ribéreau-Gayon">Régis Ribéreau-Gayon</name>
<affiliation wicri:level="1"><nlm:affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex</wicri:regionArea>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><nlm:affiliation>University Hospital of Bordeaux, Pole of Medicine, Bordeaux, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>University Hospital of Bordeaux, Pole of Medicine, Bordeaux</wicri:regionArea>
<placeName><region type="region">Nouvelle-Aquitaine</region>
<region type="old region">Aquitaine</region>
<settlement type="city">Bordeaux</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Galinski, Michel" sort="Galinski, Michel" uniqKey="Galinski M" first="Michel" last="Galinski">Michel Galinski</name>
<affiliation wicri:level="3"><nlm:affiliation>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux</wicri:regionArea>
<placeName><region type="region">Nouvelle-Aquitaine</region>
<region type="old region">Aquitaine</region>
<settlement type="city">Bordeaux</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex</wicri:regionArea>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Salmi, Louis Rachid" sort="Salmi, Louis Rachid" uniqKey="Salmi L" first="Louis-Rachid" last="Salmi">Louis-Rachid Salmi</name>
<affiliation wicri:level="1"><nlm:affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex</wicri:regionArea>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><nlm:affiliation>University Hospital of Bordeaux, Pole of Public Health, Bordeaux, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>University Hospital of Bordeaux, Pole of Public Health, Bordeaux</wicri:regionArea>
<placeName><region type="region">Nouvelle-Aquitaine</region>
<region type="old region">Aquitaine</region>
<settlement type="city">Bordeaux</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Revel, Philippe" sort="Revel, Philippe" uniqKey="Revel P" first="Philippe" last="Revel">Philippe Revel</name>
<affiliation wicri:level="3"><nlm:affiliation>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux</wicri:regionArea>
<placeName><region type="region">Nouvelle-Aquitaine</region>
<region type="old region">Aquitaine</region>
<settlement type="city">Bordeaux</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex</wicri:regionArea>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Regis, Cyril Alexandre" sort="Regis, Cyril Alexandre" uniqKey="Regis C" first="Cyril Alexandre" last="Régis">Cyril Alexandre Régis</name>
<affiliation wicri:level="1"><nlm:affiliation>CASPERTT, Hospital Center of Cadillac, Lormont, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>CASPERTT, Hospital Center of Cadillac, Lormont</wicri:regionArea>
<wicri:noRegion>Lormont</wicri:noRegion>
<wicri:noRegion>Lormont</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Valdenaire, Guillaume" sort="Valdenaire, Guillaume" uniqKey="Valdenaire G" first="Guillaume" last="Valdenaire">Guillaume Valdenaire</name>
<affiliation wicri:level="3"><nlm:affiliation>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux</wicri:regionArea>
<placeName><region type="region">Nouvelle-Aquitaine</region>
<region type="old region">Aquitaine</region>
<settlement type="city">Bordeaux</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex</wicri:regionArea>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Poulet, Emmanuel" sort="Poulet, Emmanuel" uniqKey="Poulet E" first="Emmanuel" last="Poulet">Emmanuel Poulet</name>
<affiliation wicri:level="3"><nlm:affiliation>University Hospital, Claude Bernard University, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>University Hospital, Claude Bernard University, Lyon</wicri:regionArea>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:affiliation>Department of Psychiatry, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Psychiatry, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon</wicri:regionArea>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Tazarourte, Karim" sort="Tazarourte, Karim" uniqKey="Tazarourte K" first="Karim" last="Tazarourte">Karim Tazarourte</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Emergency Medicine, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Emergency Medicine, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon</wicri:regionArea>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:affiliation>EA 7425 Hesper University Hospital, Claude Bernard University, Lyon, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>EA 7425 Hesper University Hospital, Claude Bernard University, Lyon</wicri:regionArea>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lagarde, Emmanuel" sort="Lagarde, Emmanuel" uniqKey="Lagarde E" first="Emmanuel" last="Lagarde">Emmanuel Lagarde</name>
<affiliation wicri:level="1"><nlm:affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex</wicri:regionArea>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
<wicri:noRegion>Bordeaux Cedex</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint><date when="2018" type="published">2018</date>
</imprint>
</series>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Brain Concussion (diagnosis)</term>
<term>Brain Concussion (physiopathology)</term>
<term>Brain Concussion (psychology)</term>
<term>Brain Concussion (therapy)</term>
<term>Emergency Service, Hospital (MeSH)</term>
<term>Eye Movement Desensitization Reprocessing (methods)</term>
<term>Eye Movements (MeSH)</term>
<term>France (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Multicenter Studies as Topic (MeSH)</term>
<term>Post-Concussion Syndrome (diagnosis)</term>
<term>Post-Concussion Syndrome (physiopathology)</term>
<term>Post-Concussion Syndrome (prevention & control)</term>
<term>Post-Concussion Syndrome (psychology)</term>
<term>Randomized Controlled Trials as Topic (MeSH)</term>
<term>Risk Factors (MeSH)</term>
<term>Time Factors (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Commotion de l'encéphale (diagnostic)</term>
<term>Commotion de l'encéphale (physiopathologie)</term>
<term>Commotion de l'encéphale (psychologie)</term>
<term>Commotion de l'encéphale (thérapie)</term>
<term>Désensibilisation et reprogrammation par mouvements oculaires (méthodes)</term>
<term>Essais contrôlés randomisés comme sujet (MeSH)</term>
<term>Facteurs de risque (MeSH)</term>
<term>Facteurs temps (MeSH)</term>
<term>France (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Mouvements oculaires (MeSH)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Service hospitalier d'urgences (MeSH)</term>
<term>Syndrome post-commotionnel (diagnostic)</term>
<term>Syndrome post-commotionnel (physiopathologie)</term>
<term>Syndrome post-commotionnel (prévention et contrôle)</term>
<term>Syndrome post-commotionnel (psychologie)</term>
<term>Études multicentriques comme sujet (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Brain Concussion</term>
<term>Post-Concussion Syndrome</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Commotion de l'encéphale</term>
<term>Syndrome post-commotionnel</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Eye Movement Desensitization Reprocessing</term>
</keywords>
<keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Désensibilisation et reprogrammation par mouvements oculaires</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr"><term>Commotion de l'encéphale</term>
<term>Syndrome post-commotionnel</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Brain Concussion</term>
<term>Post-Concussion Syndrome</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Post-Concussion Syndrome</term>
</keywords>
<keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Syndrome post-commotionnel</term>
</keywords>
<keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Commotion de l'encéphale</term>
<term>Syndrome post-commotionnel</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Brain Concussion</term>
<term>Post-Concussion Syndrome</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Brain Concussion</term>
</keywords>
<keywords scheme="MESH" qualifier="thérapie" xml:lang="fr"><term>Commotion de l'encéphale</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Emergency Service, Hospital</term>
<term>Eye Movements</term>
<term>Humans</term>
<term>Multicenter Studies as Topic</term>
<term>Randomized Controlled Trials as Topic</term>
<term>Risk Factors</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>France</term>
<term>Humains</term>
<term>Mouvements oculaires</term>
<term>Résultat thérapeutique</term>
<term>Service hospitalier d'urgences</term>
<term>Études multicentriques comme sujet</term>
</keywords>
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<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>Recent data suggest that 10-20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decline in quality of life. A preliminary randomized control trial suggested that this condition may be induced by the stress experienced during the event or emergency room (ER) stay and can be prevented in up to 75% of patients with a single, early, short eye movement desensitization and reprocessing (EMDR) psychotherapeutic session delivered in the ER. The protocol of the SOFTER 3 study was designed to compare the impact on 3-month PCLS of early EMDR intervention and usual care in patients presenting at the ER. Secondary outcomes included 3-month post-traumatic stress disorder, 12-month PCLS, self-reported stress at the ER, self-assessed recovery expectation at discharge and 3 months, and self-reported chronic pain at discharge and 3 months.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>This is a two-group, open-label, multicenter, comparative, randomized controlled trial with 3- and 12-month phone follow-up for reports of persisting symptoms (PCLS and post-traumatic stress disorder). Those eligible for inclusion were adults (≥18 years old) presenting at the ER departments of the University Hospital of Bordeaux and University Hospital of Lyon, assessed as being at high risk of PCLS using a three-item scoring rule. The intervention groups were a (1) EMDR Recent Traumatic Episode Protocol intervention performed by a trained psychologist during ER stay or (2) usual care. The number of patients to be enrolled in each group was 223 to evidence a 15% decrease in PCLS prevalence in the EMDR group.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>DISCUSSION</b>
</p>
<p>In 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b>
</p>
<p>Clinical Trials. NCT03400813 . Registered 17 January 2018 - retrospectively registered.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30314512</PMID>
<DateCompleted><Year>2019</Year>
<Month>01</Month>
<Day>23</Day>
</DateCompleted>
<DateRevised><Year>2019</Year>
<Month>01</Month>
<Day>23</Day>
</DateRevised>
<Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>19</Volume>
<Issue>1</Issue>
<PubDate><Year>2018</Year>
<Month>Oct</Month>
<Day>12</Day>
</PubDate>
</JournalIssue>
<Title>Trials</Title>
<ISOAbbreviation>Trials</ISOAbbreviation>
</Journal>
<ArticleTitle>Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial.</ArticleTitle>
<Pagination><MedlinePgn>555</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-018-2902-2</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Recent data suggest that 10-20% of injury patients will suffer for several months after the event from diverse symptoms, generally referred to as post-concussion-like symptoms (PCLS), which will lead to a decline in quality of life. A preliminary randomized control trial suggested that this condition may be induced by the stress experienced during the event or emergency room (ER) stay and can be prevented in up to 75% of patients with a single, early, short eye movement desensitization and reprocessing (EMDR) psychotherapeutic session delivered in the ER. The protocol of the SOFTER 3 study was designed to compare the impact on 3-month PCLS of early EMDR intervention and usual care in patients presenting at the ER. Secondary outcomes included 3-month post-traumatic stress disorder, 12-month PCLS, self-reported stress at the ER, self-assessed recovery expectation at discharge and 3 months, and self-reported chronic pain at discharge and 3 months.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">This is a two-group, open-label, multicenter, comparative, randomized controlled trial with 3- and 12-month phone follow-up for reports of persisting symptoms (PCLS and post-traumatic stress disorder). Those eligible for inclusion were adults (≥18 years old) presenting at the ER departments of the University Hospital of Bordeaux and University Hospital of Lyon, assessed as being at high risk of PCLS using a three-item scoring rule. The intervention groups were a (1) EMDR Recent Traumatic Episode Protocol intervention performed by a trained psychologist during ER stay or (2) usual care. The number of patients to be enrolled in each group was 223 to evidence a 15% decrease in PCLS prevalence in the EMDR group.</AbstractText>
<AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">In 2012, the year of the last national survey in France, 10.6 million people attended the ER, some of whom did so several times since 18 million visits were recorded in the same year. The SOFTER 3 study therefore addresses a major public health challenge.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Clinical Trials. NCT03400813 . Registered 17 January 2018 - retrospectively registered.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gil-Jardiné</LastName>
<ForeName>Cédric</ForeName>
<Initials>C</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0001-5329-6405</Identifier>
<AffiliationInfo><Affiliation>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France. cedric.gil-jardine@chu-bordeaux.fr.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France. cedric.gil-jardine@chu-bordeaux.fr.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Emergency Department, University Hospital of Bordeaux, Pellegrin Hospital, Place Amélie Raba-Léon, 33000, Bordeaux, France. cedric.gil-jardine@chu-bordeaux.fr.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Bordeaux University Hospital, Centre Hospitalier Universitaire de Bordeaux, 12 rue Dubernat, 33400, Talence, France. cedric.gil-jardine@chu-bordeaux.fr.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Al Joboory</LastName>
<ForeName>Samantha</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>CASPERTT, Hospital Center of Cadillac, Lormont, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jammes</LastName>
<ForeName>Juliane Tortes Saint</ForeName>
<Initials>JTS</Initials>
<AffiliationInfo><Affiliation>CASPERTT, Hospital Center of Cadillac, Lormont, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Durand</LastName>
<ForeName>Guillaume</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Emergency Medicine, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>University Hospital, Claude Bernard University, Lyon, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ribéreau-Gayon</LastName>
<ForeName>Régis</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>University Hospital of Bordeaux, Pole of Medicine, Bordeaux, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Galinski</LastName>
<ForeName>Michel</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Salmi</LastName>
<ForeName>Louis-Rachid</ForeName>
<Initials>LR</Initials>
<AffiliationInfo><Affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>University Hospital of Bordeaux, Pole of Public Health, Bordeaux, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Revel</LastName>
<ForeName>Philippe</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Régis</LastName>
<ForeName>Cyril Alexandre</ForeName>
<Initials>CA</Initials>
<AffiliationInfo><Affiliation>CASPERTT, Hospital Center of Cadillac, Lormont, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Valdenaire</LastName>
<ForeName>Guillaume</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>University Hospital of Bordeaux, Pole of Emergency Medicine, Bordeaux, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>INSERM, ISPED, Bordeaux Population Health research center INSERM U1219 - "Injury Epidemiology Transport Occupation" team, Bordeaux Cedex, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Poulet</LastName>
<ForeName>Emmanuel</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>University Hospital, Claude Bernard University, Lyon, France.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Psychiatry, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon, France.</Affiliation>
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Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial.

Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial.

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