<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/NCT02223845</url>
  </required_header>
  <id_info>
    <org_study_id>RHMO&amp;G0201</org_study_id>
    <nct_id>NCT02223845</nct_id>
  </id_info>
  <brief_title>Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.</brief_title>
  <official_title>Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southampton</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether listening to music at the time of embryo transfer reduces anxiety&#xD;
      levels in women undergoing assisted conception treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An assessor-blinded randomized case control study in an IVF center, England UK will randomise&#xD;
      women into 'music' (listened to self-selected music during embryo transfer) or 'control' (no&#xD;
      music) groups. Participants will complete the Spielberger State-Trait Anxiety Inventory prior&#xD;
      to, and immediately following a post-treatment observation period. Total scores will be&#xD;
      compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety level</measure>
    <time_frame>20 minutes</time_frame>
    <description>Participants completed the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores were compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Background anxiety</measure>
    <time_frame>20 minutes prior to ET</time_frame>
    <description>Background anxiety is the state anxiety of the women</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life scores</measure>
    <time_frame>20 minutes prior to ET</time_frame>
    <description>Quality of life scores as measured by a specific fertility questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>At 2 weeks and 6 weeks after ET</time_frame>
    <description>Ongoing pregnancy rate as measured by BHG and ultrasound</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Played music during embryo transfer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No music played during embryo transfer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music</intervention_name>
    <description>Self-selected music played via headphones</description>
    <arm_group_label>Music</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible participants were women aged between 25-40 years, undergoing IVF or ICSI with&#xD;
        fresh or frozen embryos to completion from February 2013 to December 2013.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Women unable to consent or with hearing impairment were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Complete Fertility</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 5YA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Music, Anxiety, IVF</keyword>
  <!-- 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/NCT02223845
org study id: RHMO&G0201
nct id: NCT02223845
lead sponsor: 
has dmc: Yes
To investigate whether listening to music at the time of embryo transfer reduces anxiety
      levels in women undergoing assisted conception treatment.
An assessor-blinded randomized case control study in an IVF center, England UK will randomise
      women into 'music' (listened to self-selected music during embryo transfer) or 'control' (no
      music) groups. Participants will complete the Spielberger State-Trait Anxiety Inventory prior
      to, and immediately following a post-treatment observation period. Total scores will be
      compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Anxiety level
time frame: 20 minutes
description: Participants completed the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores were compared.
measure: Background anxiety
time frame: 20 minutes prior to ET
description: Background anxiety is the state anxiety of the women
measure: Quality of life scores
time frame: 20 minutes prior to ET
description: Quality of life scores as measured by a specific fertility questionnaire
measure: Ongoing pregnancy rate
time frame: At 2 weeks and 6 weeks after ET
description: Ongoing pregnancy rate as measured by BHG and ultrasound
arm group label: Music
arm group type: Experimental
description: Played music during embryo transfer
arm group label: Control
arm group type: No Intervention
description: No music played during embryo transfer
intervention type: Other
intervention name: Music
description: Self-selected music played via headphones
arm group label: Music
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor