Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA)
Non-invasive ventilation (NIV) tolerance is a key factor of NIV success. Hence, numerous sedative pharmacological or non-pharmacological strategies have been assessed to improve NIV tolerance. Music therapy in various health care settings has shown beneficial effects. In invasively ventilated critic...
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| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2016-09, Vol.17 (1), p.450-450, Article 450 |
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| creator | Messika, Jonathan Hajage, David Panneckoucke, Nataly Villard, Serge Martin, Yolaine Renard, Emilie Blivet, Annie Reignier, Jean Maquigneau, Natacha Stoclin, Annabelle Puechberty, Christelle Guétin, Stéphane Dechanet, Aline Fauquembergue, Amandine Gaudry, Stéphane Dreyfuss, Didier Ricard, Jean-Damien |
| description | Non-invasive ventilation (NIV) tolerance is a key factor of NIV success. Hence, numerous sedative pharmacological or non-pharmacological strategies have been assessed to improve NIV tolerance. Music therapy in various health care settings has shown beneficial effects. In invasively ventilated critical care patients, encouraging results of music therapy on physiological parameters, anxiety, and agitation have been reported. We hypothesize that a musical intervention improves NIV tolerance in comparison to conventional care. We therefore question the potential benefit of a receptive music session administered to patients by trained caregivers ("musical intervention") to enhance acceptance and tolerance of NIV.
We conduct a prospective, three-center, open-label, three-arm randomized trial involving patients in the intensive care unit (ICU) who require NIV, as assessed by the treating physician. Participants are allocated to a "musical intervention" arm ("musical intervention" applied during all NIV sessions), to a "sensory deprivation" arm (sight and hearing isolation during all NIV sessions), or to the control group. The primary endpoint is the change in respiratory comfort (measured with a digital visual scale) before the initiation and after 30 minutes of the first NIV session. The evaluation of the primary endpoint is performed blindly from the treatment group. Secondary endpoints include changes in respiratory and cardiovascular parameters during NIV sessions, the percentage of patients requiring endotracheal intubation, day-90 anxiety/depression and health-related quality of life, post-trauma stress induced by NIV, and the overall assessment of NIV. The follow-up for each participant is 90 days. We expect to randomize a total of 99 participants.
As music intervention is a simple and easy-to-implement non-pharmacological technique, efficacious in reducing anxiety in critically ill patients, it appeared logical to assess its efficacy in NIV, one of the most stressful techniques used in the ICU. Patient centeredness was crucial in choosing the outcomes assessed.
ClinicalTrials.gov: NCT02265458 . Registered on 25 August 2014. |
| doi_str_mv | 10.1186/s13063-016-1574-z |
| format | Article |
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We conduct a prospective, three-center, open-label, three-arm randomized trial involving patients in the intensive care unit (ICU) who require NIV, as assessed by the treating physician. Participants are allocated to a "musical intervention" arm ("musical intervention" applied during all NIV sessions), to a "sensory deprivation" arm (sight and hearing isolation during all NIV sessions), or to the control group. The primary endpoint is the change in respiratory comfort (measured with a digital visual scale) before the initiation and after 30 minutes of the first NIV session. The evaluation of the primary endpoint is performed blindly from the treatment group. Secondary endpoints include changes in respiratory and cardiovascular parameters during NIV sessions, the percentage of patients requiring endotracheal intubation, day-90 anxiety/depression and health-related quality of life, post-trauma stress induced by NIV, and the overall assessment of NIV. The follow-up for each participant is 90 days. We expect to randomize a total of 99 participants.
As music intervention is a simple and easy-to-implement non-pharmacological technique, efficacious in reducing anxiety in critically ill patients, it appeared logical to assess its efficacy in NIV, one of the most stressful techniques used in the ICU. Patient centeredness was crucial in choosing the outcomes assessed.
ClinicalTrials.gov: NCT02265458 . Registered on 25 August 2014.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-016-1574-z</identifier><identifier>PMID: 27618935</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adult ; Analysis ; Anxiety ; Artificial respiration ; Caregivers ; Clinical Protocols ; Headphones ; Humans ; Intensive care ; Intensive Care Units ; Intervention ; Intubation ; Management ; Medical protocols ; Mortality ; Music Therapy ; Noninvasive Ventilation ; Nursing ; Patient satisfaction ; Patient-Centered Care ; Physiology ; Prospective Studies ; Study Protocol ; Treatment outcome ; Ventilators</subject><ispartof>Current controlled trials in cardiovascular medicine, 2016-09, Vol.17 (1), p.450-450, Article 450</ispartof><rights>COPYRIGHT 2016 BioMed Central Ltd.</rights><rights>The Author(s). 2016. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s). 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c527t-820f592ee8a95c84c456a88b3ea84abdd4e3aa285c10ec7653e0033c8e59f7fe3</citedby><cites>FETCH-LOGICAL-c527t-820f592ee8a95c84c456a88b3ea84abdd4e3aa285c10ec7653e0033c8e59f7fe3</cites><orcidid>0000-0003-2123-3527</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020479/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020479/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,27929,27930,53796,53798</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27618935$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Messika, Jonathan</creatorcontrib><creatorcontrib>Hajage, David</creatorcontrib><creatorcontrib>Panneckoucke, Nataly</creatorcontrib><creatorcontrib>Villard, Serge</creatorcontrib><creatorcontrib>Martin, Yolaine</creatorcontrib><creatorcontrib>Renard, Emilie</creatorcontrib><creatorcontrib>Blivet, Annie</creatorcontrib><creatorcontrib>Reignier, Jean</creatorcontrib><creatorcontrib>Maquigneau, Natacha</creatorcontrib><creatorcontrib>Stoclin, Annabelle</creatorcontrib><creatorcontrib>Puechberty, Christelle</creatorcontrib><creatorcontrib>Guétin, Stéphane</creatorcontrib><creatorcontrib>Dechanet, Aline</creatorcontrib><creatorcontrib>Fauquembergue, Amandine</creatorcontrib><creatorcontrib>Gaudry, Stéphane</creatorcontrib><creatorcontrib>Dreyfuss, Didier</creatorcontrib><creatorcontrib>Ricard, Jean-Damien</creatorcontrib><title>Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA)</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>Trials</addtitle><description>Non-invasive ventilation (NIV) tolerance is a key factor of NIV success. Hence, numerous sedative pharmacological or non-pharmacological strategies have been assessed to improve NIV tolerance. Music therapy in various health care settings has shown beneficial effects. In invasively ventilated critical care patients, encouraging results of music therapy on physiological parameters, anxiety, and agitation have been reported. We hypothesize that a musical intervention improves NIV tolerance in comparison to conventional care. We therefore question the potential benefit of a receptive music session administered to patients by trained caregivers ("musical intervention") to enhance acceptance and tolerance of NIV.
We conduct a prospective, three-center, open-label, three-arm randomized trial involving patients in the intensive care unit (ICU) who require NIV, as assessed by the treating physician. Participants are allocated to a "musical intervention" arm ("musical intervention" applied during all NIV sessions), to a "sensory deprivation" arm (sight and hearing isolation during all NIV sessions), or to the control group. The primary endpoint is the change in respiratory comfort (measured with a digital visual scale) before the initiation and after 30 minutes of the first NIV session. The evaluation of the primary endpoint is performed blindly from the treatment group. Secondary endpoints include changes in respiratory and cardiovascular parameters during NIV sessions, the percentage of patients requiring endotracheal intubation, day-90 anxiety/depression and health-related quality of life, post-trauma stress induced by NIV, and the overall assessment of NIV. The follow-up for each participant is 90 days. We expect to randomize a total of 99 participants.
As music intervention is a simple and easy-to-implement non-pharmacological technique, efficacious in reducing anxiety in critically ill patients, it appeared logical to assess its efficacy in NIV, one of the most stressful techniques used in the ICU. Patient centeredness was crucial in choosing the outcomes assessed.
ClinicalTrials.gov: NCT02265458 . Registered on 25 August 2014.</description><subject>Adult</subject><subject>Analysis</subject><subject>Anxiety</subject><subject>Artificial respiration</subject><subject>Caregivers</subject><subject>Clinical Protocols</subject><subject>Headphones</subject><subject>Humans</subject><subject>Intensive care</subject><subject>Intensive Care Units</subject><subject>Intervention</subject><subject>Intubation</subject><subject>Management</subject><subject>Medical protocols</subject><subject>Mortality</subject><subject>Music Therapy</subject><subject>Noninvasive Ventilation</subject><subject>Nursing</subject><subject>Patient satisfaction</subject><subject>Patient-Centered Care</subject><subject>Physiology</subject><subject>Prospective Studies</subject><subject>Study Protocol</subject><subject>Treatment outcome</subject><subject>Ventilators</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNptUt1uFCEUnhiNrdUH8MaQeGG9mAoDzDBemGw2rW7SxqS614RlDlsaBlaY2WT3IX2msru1tsZAwgl8Pxz4iuItwWeEiPpTIhTXtMSkLglvWLl9VhyThvGyrgh__qg-Kl6ldIsxoy1lL4ujqqmJaCk_Ln6fGwN6QMEghfoxWa0csn6AuAY_2OBRnkNwEJXXgJTvEBiTUXqz4_jgS-vXKtk1oD3DqT3LZtYNoNl0_hmlYew2aBXDEHRwyISYvbJeF3q7hQ7p4IcYnMvlEG32P72a_7C_RkCrMEbkPsx8GrNp2l_hGtLKRjUEGwFN7DLDSnQ1pnJ2Pfn4unhhlEvw5n49KeYX5z-n38rL719n08llqXnVDKWosOFtBSBUy7VgmvFaCbGgoARTi65jQJWqBNcEg25qTgFjSrUA3prGAD0pvhx0V-Oih07nzqNychVtr-JGBmXl0xNvb-QyrCXHFWZNmwVO7wViyJ2mQfY2aXBOeQhjkkSQllFMGpGh7_-B3uZn8bk9WTUtryhrKvYXtVQOpPUmZF-9E5UTVvM6Q0mdUWf_QeXRQW_zP4Cxef8JgRwIOoaUIpiHHgmWuxDKQwhlDqHchVBuM-fd48d5YPxJHb0DCtvbFw</recordid><startdate>20160913</startdate><enddate>20160913</enddate><creator>Messika, Jonathan</creator><creator>Hajage, David</creator><creator>Panneckoucke, Nataly</creator><creator>Villard, Serge</creator><creator>Martin, Yolaine</creator><creator>Renard, Emilie</creator><creator>Blivet, Annie</creator><creator>Reignier, Jean</creator><creator>Maquigneau, Natacha</creator><creator>Stoclin, Annabelle</creator><creator>Puechberty, Christelle</creator><creator>Guétin, Stéphane</creator><creator>Dechanet, Aline</creator><creator>Fauquembergue, Amandine</creator><creator>Gaudry, Stéphane</creator><creator>Dreyfuss, Didier</creator><creator>Ricard, Jean-Damien</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-2123-3527</orcidid></search><sort><creationdate>20160913</creationdate><title>Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA)</title><author>Messika, Jonathan ; Hajage, David ; Panneckoucke, Nataly ; Villard, Serge ; Martin, Yolaine ; Renard, Emilie ; Blivet, Annie ; Reignier, Jean ; Maquigneau, Natacha ; Stoclin, Annabelle ; Puechberty, Christelle ; Guétin, Stéphane ; Dechanet, Aline ; Fauquembergue, Amandine ; Gaudry, Stéphane ; Dreyfuss, Didier ; Ricard, Jean-Damien</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c527t-820f592ee8a95c84c456a88b3ea84abdd4e3aa285c10ec7653e0033c8e59f7fe3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Analysis</topic><topic>Anxiety</topic><topic>Artificial respiration</topic><topic>Caregivers</topic><topic>Clinical Protocols</topic><topic>Headphones</topic><topic>Humans</topic><topic>Intensive care</topic><topic>Intensive Care Units</topic><topic>Intervention</topic><topic>Intubation</topic><topic>Management</topic><topic>Medical protocols</topic><topic>Mortality</topic><topic>Music Therapy</topic><topic>Noninvasive Ventilation</topic><topic>Nursing</topic><topic>Patient satisfaction</topic><topic>Patient-Centered Care</topic><topic>Physiology</topic><topic>Prospective Studies</topic><topic>Study Protocol</topic><topic>Treatment outcome</topic><topic>Ventilators</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Messika, Jonathan</creatorcontrib><creatorcontrib>Hajage, David</creatorcontrib><creatorcontrib>Panneckoucke, Nataly</creatorcontrib><creatorcontrib>Villard, Serge</creatorcontrib><creatorcontrib>Martin, Yolaine</creatorcontrib><creatorcontrib>Renard, Emilie</creatorcontrib><creatorcontrib>Blivet, Annie</creatorcontrib><creatorcontrib>Reignier, Jean</creatorcontrib><creatorcontrib>Maquigneau, Natacha</creatorcontrib><creatorcontrib>Stoclin, Annabelle</creatorcontrib><creatorcontrib>Puechberty, Christelle</creatorcontrib><creatorcontrib>Guétin, Stéphane</creatorcontrib><creatorcontrib>Dechanet, Aline</creatorcontrib><creatorcontrib>Fauquembergue, Amandine</creatorcontrib><creatorcontrib>Gaudry, Stéphane</creatorcontrib><creatorcontrib>Dreyfuss, Didier</creatorcontrib><creatorcontrib>Ricard, Jean-Damien</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Messika, Jonathan</au><au>Hajage, David</au><au>Panneckoucke, Nataly</au><au>Villard, Serge</au><au>Martin, Yolaine</au><au>Renard, Emilie</au><au>Blivet, Annie</au><au>Reignier, Jean</au><au>Maquigneau, Natacha</au><au>Stoclin, Annabelle</au><au>Puechberty, Christelle</au><au>Guétin, Stéphane</au><au>Dechanet, Aline</au><au>Fauquembergue, Amandine</au><au>Gaudry, Stéphane</au><au>Dreyfuss, Didier</au><au>Ricard, Jean-Damien</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA)</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><addtitle>Trials</addtitle><date>2016-09-13</date><risdate>2016</risdate><volume>17</volume><issue>1</issue><spage>450</spage><epage>450</epage><pages>450-450</pages><artnum>450</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>Non-invasive ventilation (NIV) tolerance is a key factor of NIV success. Hence, numerous sedative pharmacological or non-pharmacological strategies have been assessed to improve NIV tolerance. Music therapy in various health care settings has shown beneficial effects. In invasively ventilated critical care patients, encouraging results of music therapy on physiological parameters, anxiety, and agitation have been reported. We hypothesize that a musical intervention improves NIV tolerance in comparison to conventional care. We therefore question the potential benefit of a receptive music session administered to patients by trained caregivers ("musical intervention") to enhance acceptance and tolerance of NIV.
We conduct a prospective, three-center, open-label, three-arm randomized trial involving patients in the intensive care unit (ICU) who require NIV, as assessed by the treating physician. Participants are allocated to a "musical intervention" arm ("musical intervention" applied during all NIV sessions), to a "sensory deprivation" arm (sight and hearing isolation during all NIV sessions), or to the control group. The primary endpoint is the change in respiratory comfort (measured with a digital visual scale) before the initiation and after 30 minutes of the first NIV session. The evaluation of the primary endpoint is performed blindly from the treatment group. Secondary endpoints include changes in respiratory and cardiovascular parameters during NIV sessions, the percentage of patients requiring endotracheal intubation, day-90 anxiety/depression and health-related quality of life, post-trauma stress induced by NIV, and the overall assessment of NIV. The follow-up for each participant is 90 days. We expect to randomize a total of 99 participants.
As music intervention is a simple and easy-to-implement non-pharmacological technique, efficacious in reducing anxiety in critically ill patients, it appeared logical to assess its efficacy in NIV, one of the most stressful techniques used in the ICU. Patient centeredness was crucial in choosing the outcomes assessed.
ClinicalTrials.gov: NCT02265458 . Registered on 25 August 2014.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>27618935</pmid><doi>10.1186/s13063-016-1574-z</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0003-2123-3527</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Current controlled trials in cardiovascular medicine, 2016-09, Vol.17 (1), p.450-450, Article 450 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; SpringerNature Journals; PubMed Central Open Access; PubMed Central; Springer Nature OA/Free Journals |
| subjects | Adult Analysis Anxiety Artificial respiration Caregivers Clinical Protocols Headphones Humans Intensive care Intensive Care Units Intervention Intubation Management Medical protocols Mortality Music Therapy Noninvasive Ventilation Nursing Patient satisfaction Patient-Centered Care Physiology Prospective Studies Study Protocol Treatment outcome Ventilators |
| title | Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA) |
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