<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/NCT01687933</url>
  </required_header>
  <id_info>
    <org_study_id>Virtual Reality System</org_study_id>
    <nct_id>NCT01687933</nct_id>
  </id_info>
  <brief_title>The Effect of Virtual Reality Glasses on Labor Pain</brief_title>
  <official_title>Principal Investigator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are different medicinal and non medicinal methods to control labor pain. Today, much&#xD;
      attention has been on non medicinal methods because of limitations and complications of&#xD;
      medical procedures. Virtual reality is a new and promising method of diversion of mind that&#xD;
      may have an impact on labor pain. This study was conducted to determine the effect of virtual&#xD;
      reality on the first stage of labor pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>Phase 2/Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain and anxiety</measure>
    <time_frame>up to 8 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Labor Pain</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>three-dimensional glasses (Virtual Reality glasses)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in case group used the glasses for 30 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in control group did not use the glasses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>three-dimensional glasses(manufactor Vuzix,wrap 920)</intervention_name>
    <description>The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain.</description>
    <arm_group_label>three-dimensional glasses (Virtual Reality glasses)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>Women in Control group did not use the glasses.</description>
    <arm_group_label>usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Iranian&#xD;
&#xD;
          -  low risk pregnancy&#xD;
&#xD;
          -  primipara&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vision or ear disorders&#xD;
&#xD;
          -  History of motion sickness or headaches&#xD;
&#xD;
          -  psychological disease or Addiction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 15, 2012</last_update_submitted>
  <last_update_submitted_qc>September 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Samira Ebrahimzadeh Zagami</investigator_full_name>
    <investigator_title>MUMS</investigator_title>
  </responsible_party>
  <keyword>Labor pain</keyword>
  <keyword>Virtual reality</keyword>
  <keyword>the first stage of labor</keyword>
  <keyword>Pain relief</keyword>
  <keyword>Simulator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT01687933
org study id: Virtual Reality System
nct id: NCT01687933
lead sponsor: 
has dmc: Yes
There are different medicinal and non medicinal methods to control labor pain. Today, much
      attention has been on non medicinal methods because of limitations and complications of
      medical procedures. Virtual reality is a new and promising method of diversion of mind that
      may have an impact on labor pain. This study was conducted to determine the effect of virtual
      reality on the first stage of labor pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain and anxiety
time frame: up to 8 months
arm group label: three-dimensional glasses (Virtual Reality glasses)
arm group type: Experimental
description: Women in case group used the glasses for 30 minutes
arm group label: usual care
arm group type: Experimental
description: Women in control group did not use the glasses.
intervention type: Device
intervention name: three-dimensional glasses(manufactor Vuzix,wrap 920)
description: The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain.
arm group label: three-dimensional glasses (Virtual Reality glasses)
intervention type: Other
intervention name: usual care
description: Women in Control group did not use the glasses.
arm group label: usual care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: Samira Ebrahimzadeh Zagami
investigator title: MUMS
mesh term: Labor Pain