<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426110</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200330</org_study_id>
    <nct_id>NCT04426110</nct_id>
  </id_info>
  <brief_title>Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches</brief_title>
  <acronym>PLAY</acronym>
  <official_title>Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches in Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to measure the effect of music therapy on pain and anxiety levels&#xD;
      during stitches procedure in an adult emergency department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Wounds represent a frequent reason for admission to emergency department (5 to 7% of visits),&#xD;
      inducing pain and anxiety due to the trauma itself and also to the treatment, stitches being&#xD;
      the most frequently used procedure.&#xD;
&#xD;
      Alternative, non-pharmacologic strategies may help reduce pain and anxiety associated with&#xD;
      painful bedside procedures. Music is one of them, easy to use and without any side effects.&#xD;
&#xD;
      Music therapy has already been shown to reduce pain and anxiety levels in children during&#xD;
      medical procedures (blood test, vaccination, lumbar puncture) and in adults during surgical&#xD;
      or anaesthetic procedures.&#xD;
&#xD;
      Our objective is to apply this technic to adults in emergency departments during stitches&#xD;
      wound management.&#xD;
&#xD;
      This is a study before / after the implementation of a music therapy protocol during stiches&#xD;
      wound management. During the music period, the participant will choose and listen to one of&#xD;
      the five playlists (vocal jazz, instrumental jazz, piano, world music, Mozart) created by a&#xD;
      professional music therapist, via headphones. There will be no change in stitches wound&#xD;
      management.&#xD;
&#xD;
      Pain and anxiety levels will be measured by visual analog scale before, during and after the&#xD;
      stitches procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">December 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal pain level</measure>
    <time_frame>Day 0</time_frame>
    <description>Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal anxiety level</measure>
    <time_frame>Day 0</time_frame>
    <description>Maximum anxiety level experienced during the procedure, measured by visual analog scale immediately after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final pain level</measure>
    <time_frame>Day 0</time_frame>
    <description>Final pain level measured by visual analog scale immediately after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final anxiety level</measure>
    <time_frame>Day 0</time_frame>
    <description>Final anxiety level measured by visual analog scale immediately after the procedure.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">144</enrollment>
  <condition>Wound</condition>
  <arm_group>
    <arm_group_label>Period 1 &quot;Control&quot;</arm_group_label>
    <description>No Music. Wound stitches procedure conducted according to clinical practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 2 &quot;Music&quot;</arm_group_label>
    <description>Music by headphones. Wound stitches procedure conducted according to clinical practice</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients visiting the emergency department for an acute skin wound with need for&#xD;
        stitches.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  Acute skin wound with need for stitches&#xD;
&#xD;
          -  National health service coverage&#xD;
&#xD;
          -  No opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conditions interfering with consent or measures (no French-fluent, acute intoxication,&#xD;
             neurologic or psychiatric pathology)&#xD;
&#xD;
          -  Wound requiring surgical exploration&#xD;
&#xD;
          -  Wound localized on or around an ear&#xD;
&#xD;
          -  Major insufficiency of auditory function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre-Clément THIEBAUD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency Department Saint Antoine Hospital (AP-HP)</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.</citation>
    <PMID>16625614</PMID>
  </reference>
  <reference>
    <citation>Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005.</citation>
    <PMID>18355741</PMID>
  </reference>
  <reference>
    <citation>Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.</citation>
    <PMID>29665028</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 15, 2021</last_update_submitted>
  <last_update_submitted_qc>October 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wound</keyword>
  <keyword>Stitches</keyword>
  <keyword>Pain</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Music</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426110
org study id: APHP200330
nct id: NCT04426110
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to measure the effect of music therapy on pain and anxiety levels
      during stitches procedure in an adult emergency department.
Wounds represent a frequent reason for admission to emergency department (5 to 7% of visits),
      inducing pain and anxiety due to the trauma itself and also to the treatment, stitches being
      the most frequently used procedure.

      Alternative, non-pharmacologic strategies may help reduce pain and anxiety associated with
      painful bedside procedures. Music is one of them, easy to use and without any side effects.

      Music therapy has already been shown to reduce pain and anxiety levels in children during
      medical procedures (blood test, vaccination, lumbar puncture) and in adults during surgical
      or anaesthetic procedures.

      Our objective is to apply this technic to adults in emergency departments during stitches
      wound management.

      This is a study before / after the implementation of a music therapy protocol during stiches
      wound management. During the music period, the participant will choose and listen to one of
      the five playlists (vocal jazz, instrumental jazz, piano, world music, Mozart) created by a
      professional music therapist, via headphones. There will be no change in stitches wound
      management.

      Pain and anxiety levels will be measured by visual analog scale before, during and after the
      stitches procedure.
observational model: Other
time perspective: Prospective
measure: Maximal pain level
time frame: Day 0
description: Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.
measure: Maximal anxiety level
time frame: Day 0
description: Maximum anxiety level experienced during the procedure, measured by visual analog scale immediately after the procedure.
measure: Final pain level
time frame: Day 0
description: Final pain level measured by visual analog scale immediately after the procedure.
measure: Final anxiety level
time frame: Day 0
description: Final anxiety level measured by visual analog scale immediately after the procedure.
arm group label: Period 1 "Control"
description: No Music. Wound stitches procedure conducted according to clinical practice.
arm group label: Period 2 "Music"
description: Music by headphones. Wound stitches procedure conducted according to clinical practice
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre-Clément THIEBAUD, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
citation: Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
PMID: 16625614
citation: Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005.
PMID: 18355741
citation: Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
PMID: 29665028
responsible party type: Sponsor
sharing ipd: Undecided