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Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol.

Identifieur interne : 000019 ( Main/Exploration ); précédent : 000018; suivant : 000020

Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol.

Auteurs : Sylvie Le May [Canada] ; Argerie Tsimicalis [Canada] ; Melanie Noel [Canada] ; Pierre Rainville [Canada] ; Christelle Khadra [Canada] ; Ariane Ballard [Canada] ; Estelle Guingo [Canada] ; Casey Cotes-Turpin [Canada] ; Sofia Addab [Canada] ; Khadidja Chougui [Canada] ; Maxime Francoeur [Canada] ; Nicole Hung [Canada] ; Mitchell Bernstein [Canada] ; Stéphane Bouchard [Canada] ; Stefan Parent [Canada] ; Mathilde Hupin Debeurme [Canada]

Source :

RBID : pubmed:33098330

Abstract

AIMS

To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures.

DESIGN

Three-centre randomized clinical trial using a parallel design with two groups: experimental and control.

METHODS

Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019. Children, from 7-17 years old, requiring bone pins and/or suture removal procedures will be recruited. The intervention group (N = 94) will receive a virtual reality game (Dreamland), whereas the control group (N = 94) will receive a tablet with video games. The primary outcomes will be both the mean self-reported pain score measured by the Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale. Recalls of pain and anxiety will be measured 1 week after the procedure using the same scales. We aim to recruit 188 children to achieve a power of 80% with a significance level (alpha) of 5%.

DISCUSSION

While multiple pharmacological methods have previously been tested for children, no studies have evaluated the impact of immersive virtual reality distraction for pain and anxiety management in the orthopaedic setting.

IMPACT

Improved pain management can be achieved using virtual reality during medical procedures for children. This method is innovative, non-pharmacological, adapted to the hospital setting, and user-friendly.

TRIAL REGISTRATION

NCT03680625, registered on clinicaltrials.gov.


DOI: 10.1111/jan.14607
PubMed: 33098330


Affiliations:


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


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<b>AIMS</b>
</p>
<p>To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>DESIGN</b>
</p>
<p>Three-centre randomized clinical trial using a parallel design with two groups: experimental and control.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019. Children, from 7-17 years old, requiring bone pins and/or suture removal procedures will be recruited. The intervention group (N = 94) will receive a virtual reality game (Dreamland), whereas the control group (N = 94) will receive a tablet with video games. The primary outcomes will be both the mean self-reported pain score measured by the Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale. Recalls of pain and anxiety will be measured 1 week after the procedure using the same scales. We aim to recruit 188 children to achieve a power of 80% with a significance level (alpha) of 5%.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>DISCUSSION</b>
</p>
<p>While multiple pharmacological methods have previously been tested for children, no studies have evaluated the impact of immersive virtual reality distraction for pain and anxiety management in the orthopaedic setting.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>IMPACT</b>
</p>
<p>Improved pain management can be achieved using virtual reality during medical procedures for children. This method is innovative, non-pharmacological, adapted to the hospital setting, and user-friendly.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>TRIAL REGISTRATION</b>
</p>
<p>NCT03680625, registered on clinicaltrials.gov.</p>
</div>
</front>
</TEI>
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<Year>2021</Year>
<Month>02</Month>
<Day>22</Day>
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<ISSN IssnType="Electronic">1365-2648</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>77</Volume>
<Issue>1</Issue>
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<Year>2021</Year>
<Month>Jan</Month>
</PubDate>
</JournalIssue>
<Title>Journal of advanced nursing</Title>
<ISOAbbreviation>J Adv Nurs</ISOAbbreviation>
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<ArticleTitle>Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol.</ArticleTitle>
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<AbstractText Label="AIMS" NlmCategory="OBJECTIVE">To examine the efficacy of an immersive virtual reality distraction compared with an active non-immersive distraction, such as video games on a tablet, for pain and anxiety management and memory of pain and anxiety in children requiring percutaneous bone pins and/or suture removal procedures.</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="METHODS">Three-centre randomized clinical trial using a parallel design with two groups: experimental and control.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Study to take place in the orthopaedic department of three children hospital of the Montreal region starting in 2019. Children, from 7-17 years old, requiring bone pins and/or suture removal procedures will be recruited. The intervention group (N = 94) will receive a virtual reality game (Dreamland), whereas the control group (N = 94) will receive a tablet with video games. The primary outcomes will be both the mean self-reported pain score measured by the Numerical Rating Scale and mean anxiety score, measured by the Child Fear Scale. Recalls of pain and anxiety will be measured 1 week after the procedure using the same scales. We aim to recruit 188 children to achieve a power of 80% with a significance level (alpha) of 5%.</AbstractText>
<AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">While multiple pharmacological methods have previously been tested for children, no studies have evaluated the impact of immersive virtual reality distraction for pain and anxiety management in the orthopaedic setting.</AbstractText>
<AbstractText Label="IMPACT" NlmCategory="CONCLUSIONS">Improved pain management can be achieved using virtual reality during medical procedures for children. This method is innovative, non-pharmacological, adapted to the hospital setting, and user-friendly.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">NCT03680625, registered on clinicaltrials.gov.</AbstractText>
<CopyrightInformation>© 2020 John Wiley & Sons Ltd.</CopyrightInformation>
</Abstract>
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<Author ValidYN="Y">
<LastName>Le May</LastName>
<ForeName>Sylvie</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Research Center, CHU Sainte-Justine, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Faculty of Nursing, Université de Montréal, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Tsimicalis</LastName>
<ForeName>Argerie</ForeName>
<Initials>A</Initials>
<AffiliationInfo>
<Affiliation>Ingram School of Nursing, McGill University, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Shriners' Hospital for children in Montreal, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Noel</LastName>
<ForeName>Melanie</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Department of Psychology, University of Calgary, Calgary, AB, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Rainville</LastName>
<ForeName>Pierre</ForeName>
<Initials>P</Initials>
<AffiliationInfo>
<Affiliation>Faculty of Dental Medicine, Université de Montréal, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Khadra</LastName>
<ForeName>Christelle</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>Faculty of Medicine, McGill University, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Ballard</LastName>
<ForeName>Ariane</ForeName>
<Initials>A</Initials>
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<Affiliation>Ingram School of Nursing, McGill University, Montreal, QC, Canada.</Affiliation>
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<LastName>Guingo</LastName>
<ForeName>Estelle</ForeName>
<Initials>E</Initials>
<AffiliationInfo>
<Affiliation>UQAT Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada.</Affiliation>
</AffiliationInfo>
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<LastName>Cotes-Turpin</LastName>
<ForeName>Casey</ForeName>
<Initials>C</Initials>
<AffiliationInfo>
<Affiliation>UQAT Université du Québec en Abitibi-Témiscamingue, Rouyn-Noranda, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Addab</LastName>
<ForeName>Sofia</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Shriners' Hospital for children in Montreal, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Chougui</LastName>
<ForeName>Khadidja</ForeName>
<Initials>K</Initials>
<AffiliationInfo>
<Affiliation>Shriners' Hospital for children in Montreal, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Department of Psychology, Université de Montréal, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Francoeur</LastName>
<ForeName>Maxime</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Research Center, CHU Sainte-Justine, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Hung</LastName>
<ForeName>Nicole</ForeName>
<Initials>N</Initials>
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<AffiliationInfo>
<Affiliation>Research Center, CHU Sainte-Justine, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Faculty of Medicine, Université de Montréal, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bernstein</LastName>
<ForeName>Mitchell</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Division of Orthopaedic Surgery, McGill University Health Centre, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Bouchard</LastName>
<ForeName>Stéphane</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>UQO Université du Québec en Outaouais, Saint-Jérôme, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Parent</LastName>
<ForeName>Stefan</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Department of Surgery, CHU Sainte-Justine, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Hupin Debeurme</LastName>
<ForeName>Mathilde</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Department of Surgery, CHU Sainte-Justine, Montreal, QC, Canada.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
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<DataBank>
<DataBankName>ClinicalTrials.gov</DataBankName>
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<AccessionNumber>NCT03680625</AccessionNumber>
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</DataBankList>
<GrantList CompleteYN="Y">
<Grant>
<Agency>Centre de recherche du CHU Sainte-Justine</Agency>
<Country></Country>
</Grant>
</GrantList>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic">
<Year>2020</Year>
<Month>10</Month>
<Day>24</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>England</Country>
<MedlineTA>J Adv Nurs</MedlineTA>
<NlmUniqueID>7609811</NlmUniqueID>
<ISSNLinking>0309-2402</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
<CitationSubset>N</CitationSubset>
<OtherAbstract Type="Publisher" Language="chi">
<AbstractText>目标: 比较沉浸式虚拟现实分心与主动非沉浸式分心(如平板电脑上的电子游戏)对需要经皮骨针和/或缝线移除手术的儿童的疼痛和焦虑管理以及疼痛和焦虑记忆的有效性。 设计: 采用平行设计的三中心随机临床试验分为两组:实验组和对照组。 方法: 研究将于2019年在蒙特利尔地区三所儿童医院骨科进行。将招募7-17岁需要骨钉和/或缝线移除程序的儿童。干预组(N=94)将收到一个虚拟现实游戏(Dreamland),而对照组(N=94)将收到一个带有视频游戏的平板电脑。主要结果是数字评分量表测量的平均自我报告疼痛评分和儿童恐惧量表测量的平均焦虑评分。疼痛和焦虑的记忆将在手术后1周使用相同的量表进行测量。我们的目标是招募188名儿童达到80%的能力,显著性水平(α)为5%。 讨论: 虽然多种药理学方法之前已经在儿童身上进行过测试,但没有研究评估沉浸式虚拟现实分心对骨科环境中疼痛和焦虑管理的影响。 影响: 在儿童医疗过程中使用虚拟现实技术可以改善疼痛管理。该方法具有创新性、非药理学、适应医院环境、用户友好。.</AbstractText>
</OtherAbstract>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">anxiety</Keyword>
<Keyword MajorTopicYN="N">distraction</Keyword>
<Keyword MajorTopicYN="N">nurses</Keyword>
<Keyword MajorTopicYN="N">nursing</Keyword>
<Keyword MajorTopicYN="N">orthopaedic</Keyword>
<Keyword MajorTopicYN="N">paediatric</Keyword>
<Keyword MajorTopicYN="N">pain</Keyword>
<Keyword MajorTopicYN="N">randomized control trial</Keyword>
<Keyword MajorTopicYN="N">video games</Keyword>
<Keyword MajorTopicYN="N">virtual reality</Keyword>
</KeywordList>
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<Year>2020</Year>
<Month>07</Month>
<Day>20</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2020</Year>
<Month>09</Month>
<Day>03</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2020</Year>
<Month>09</Month>
<Day>29</Day>
</PubMedPubDate>
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<Year>2020</Year>
<Month>10</Month>
<Day>25</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<Year>2020</Year>
<Month>10</Month>
<Day>25</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="entrez">
<Year>2020</Year>
<Month>10</Month>
<Day>24</Day>
<Hour>8</Hour>
<Minute>34</Minute>
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<PublicationStatus>ppublish</PublicationStatus>
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