<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/NCT03828760</url>
  </required_header>
  <id_info>
    <org_study_id>Tuning Out</org_study_id>
    <nct_id>NCT03828760</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Music on Pain and Anxiety in IUD Insertion</brief_title>
  <official_title>Tuning Out: The Effectiveness of Music on Pain and Anxiety in Intrauterine Device Insertion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</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>
      Although intrauterine devices (IUDs) are a highly effective contraceptive method, fear of&#xD;
      pain during insertion is one barrier to use. A review of literature reveals little&#xD;
      investigation of interventions for anxiety management during the procedure. Furthermore,&#xD;
      evidence of non-pharmacological interventions for both anxiety and pain management is&#xD;
      limited. Music has been shown to be effective at reducing anxiety and pain in a variety of&#xD;
      contexts, however to the investigators' knowledge, its effectiveness for anxiety and pain&#xD;
      relief during the IUD insertion procedure has not been formally examined. This study will&#xD;
      therefore examine the effectiveness of listening to music on anxiety and pain during IUD&#xD;
      insertion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized controlled trial of patients at least 16 years of age undergoing an&#xD;
      IUD insertion. The experimental group will receive music, self-selected, with a music-playing&#xD;
      device prior and during the procedure and the control group will receive standard care. Data&#xD;
      for pain and anxiety will be collected prior to the procedure, and during, and after IUD&#xD;
      insertion. In addition, a post-procedure questionnaire will be given to patients and&#xD;
      providers to ask about satisfaction and acceptability of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 12, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The investigators and statisticians performing final data analysis will be blinded to the group allocations</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in self-reported anxiety (in the moment)</measure>
    <time_frame>Baseline, immediately after the procedure, immediately after uterine sounding</time_frame>
    <description>100 mm visual analog scale (VAS) measures anxiety reported by patients; values range 0-100 with higher values representing higher anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported pain (in the moment)</measure>
    <time_frame>Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure</time_frame>
    <description>100 mm visual analog scale (VAS) measures pain reported by patients; values range 0-100 with higher values representing higher pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety</measure>
    <time_frame>Baseline, immediately after the procedure</time_frame>
    <description>The trait anxiety subscale of the State-Trait Anxiety Inventory (Spielberger et al.,1983) will be used to measure trait anxiety. It contains 20 items, each item is rated on a 4-point scale (not at all, somewhat, moderately so, very much so), with higher values representing higher anxiety. Scores range from 20-80 (higher scores represent higher trait anxiety).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications related to IUD insertion procedure</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>Patients and providers are asked to identify any significant adverse reactions experienced (by the patient) during the IUD insertion procedure (e.g., bleeding, vasovagal responses) with open-ended survey developed for the study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perceived facilitators and barriers</measure>
    <time_frame>At study end, approximately 4 months</time_frame>
    <description>Open-ended questionnaire developed for the study asking the provider whether there are any methods to help implement listening to music during the IUD insertion procedure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Provider satisfaction and acceptability</measure>
    <time_frame>At study end, approximately 4 months</time_frame>
    <description>Open-ended questionnaire developed for the study asking provider about their opinions regarding the use of music during IUD insertion, whether they would recommend the intervention to patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient satisfaction and acceptability</measure>
    <time_frame>Immediately after the procedure</time_frame>
    <description>Open-ended questionnaire developed for the study asking patient about their opinions regarding the use of music during IUD insertion, whether they would recommend the intervention to friends.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>IUD Insertion Complication</condition>
  <condition>Pain, Acute</condition>
  <condition>Anxiety Acute</condition>
  <arm_group>
    <arm_group_label>Music Listening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive music of choice to listen to using a music-playing device in the waiting room prior to IUD insertion, as well as during the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive standard care (excluding the use of music) from providers at the clinic to minimize pain and anxiety during the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music listening</intervention_name>
    <description>Patients will be asked to either use their personal phones to listen to preferred music which is already on their device, or if they do not have a phone or other personal device capable of playing music of their choice, we will use a device (e.g. iPod) to load music of their choice. While in the waiting room, participants will listen to music through headphones/earphones, however they will need to remove their headphones/earphones during the initial consultation with the family physician (explaining risks, etc.), and resume listening to music through the phone speakers once in the examination room as patients will need to be able to hear instructions from the physician during the procedure.</description>
    <arm_group_label>Music Listening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sufficient understanding of English to complete questionnaires&#xD;
&#xD;
          -  Women who will attend the clinic for an IUD insertion and accept to participate in the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with chronic pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Lennox, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robin Lennox, MD</last_name>
    <phone>(905) 525 - 9140</phone>
    <email>robin.lennox@medportal.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>McMaster Family Practice</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Robin Lennox</investigator_full_name>
    <investigator_title>Assistant Professor and Family Physician</investigator_title>
  </responsible_party>
  <keyword>Intrauterine Device</keyword>
  <keyword>IUD</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Pain</keyword>
  <keyword>Music</keyword>
  <keyword>Contraception</keyword>
  <keyword>Visual analog scale</keyword>
  <keyword>VAS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <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/NCT03828760
org study id: Tuning Out
nct id: NCT03828760
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although intrauterine devices (IUDs) are a highly effective contraceptive method, fear of
      pain during insertion is one barrier to use. A review of literature reveals little
      investigation of interventions for anxiety management during the procedure. Furthermore,
      evidence of non-pharmacological interventions for both anxiety and pain management is
      limited. Music has been shown to be effective at reducing anxiety and pain in a variety of
      contexts, however to the investigators' knowledge, its effectiveness for anxiety and pain
      relief during the IUD insertion procedure has not been formally examined. This study will
      therefore examine the effectiveness of listening to music on anxiety and pain during IUD
      insertion.
The study is a randomized controlled trial of patients at least 16 years of age undergoing an
      IUD insertion. The experimental group will receive music, self-selected, with a music-playing
      device prior and during the procedure and the control group will receive standard care. Data
      for pain and anxiety will be collected prior to the procedure, and during, and after IUD
      insertion. In addition, a post-procedure questionnaire will be given to patients and
      providers to ask about satisfaction and acceptability of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: The investigators and statisticians performing final data analysis will be blinded to the group allocations
measure: Change in self-reported anxiety (in the moment)
time frame: Baseline, immediately after the procedure, immediately after uterine sounding
description: 100 mm visual analog scale (VAS) measures anxiety reported by patients; values range 0-100 with higher values representing higher anxiety.
measure: Change in self-reported pain (in the moment)
time frame: Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure
description: 100 mm visual analog scale (VAS) measures pain reported by patients; values range 0-100 with higher values representing higher pain.
measure: Change in anxiety
time frame: Baseline, immediately after the procedure
description: The trait anxiety subscale of the State-Trait Anxiety Inventory (Spielberger et al.,1983) will be used to measure trait anxiety. It contains 20 items, each item is rated on a 4-point scale (not at all, somewhat, moderately so, very much so), with higher values representing higher anxiety. Scores range from 20-80 (higher scores represent higher trait anxiety).
measure: Complications related to IUD insertion procedure
time frame: Immediately after the procedure
description: Patients and providers are asked to identify any significant adverse reactions experienced (by the patient) during the IUD insertion procedure (e.g., bleeding, vasovagal responses) with open-ended survey developed for the study.
measure: Perceived facilitators and barriers
time frame: At study end, approximately 4 months
description: Open-ended questionnaire developed for the study asking the provider whether there are any methods to help implement listening to music during the IUD insertion procedure.
measure: Provider satisfaction and acceptability
time frame: At study end, approximately 4 months
description: Open-ended questionnaire developed for the study asking provider about their opinions regarding the use of music during IUD insertion, whether they would recommend the intervention to patients.
measure: Patient satisfaction and acceptability
time frame: Immediately after the procedure
description: Open-ended questionnaire developed for the study asking patient about their opinions regarding the use of music during IUD insertion, whether they would recommend the intervention to friends.
arm group label: Music Listening
arm group type: Experimental
description: Patients will receive music of choice to listen to using a music-playing device in the waiting room prior to IUD insertion, as well as during the procedure.
arm group label: Standard Care
arm group type: No Intervention
description: Patients will receive standard care (excluding the use of music) from providers at the clinic to minimize pain and anxiety during the procedure.
intervention type: Behavioral
intervention name: Music listening
description: Patients will be asked to either use their personal phones to listen to preferred music which is already on their device, or if they do not have a phone or other personal device capable of playing music of their choice, we will use a device (e.g. iPod) to load music of their choice. While in the waiting room, participants will listen to music through headphones/earphones, however they will need to remove their headphones/earphones during the initial consultation with the family physician (explaining risks, etc.), and resume listening to music through the phone speakers once in the examination room as patients will need to be able to hear instructions from the physician during the procedure.
arm group label: Music Listening
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Robin Lennox, MD
role: Principal Investigator
affiliation: McMaster University
last name: Robin Lennox, MD
phone: (905) 525 - 9140
email: robin.lennox@medportal.ca
facility: 
status: Recruiting
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Robin Lennox
investigator title: Assistant Professor and Family Physician
mesh term: Acute Pain
mesh term: Anxiety Disorders
sharing ipd: Undecided