<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/NCT01663909</url>
  </required_header>
  <id_info>
    <org_study_id>Scoliosis</org_study_id>
    <nct_id>NCT01663909</nct_id>
  </id_info>
  <brief_title>Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion</brief_title>
  <official_title>The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Justine's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain&#xD;
      management a complex task. Several studies have found out that pharmacological interventions&#xD;
      alone were not enough to provide optimal pain management for these patients. The&#xD;
      investigators developed a DVD on guided imagery, customized for teenagers, to help them cope&#xD;
      better with their pain. The investigators believe that this type of intervention combined&#xD;
      with their usual analgesic medication will help them to control their pain and foster&#xD;
      rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of pain intensity</measure>
    <time_frame>Level of pain intensity at two weeks after the surgery</time_frame>
    <description>Pain was measured before the patients left the hospital on their 7th postoperative day (T-1, time of discharge from hospital). It was measured again at two week post-discharge (T-2) and also at one month post-discharge (T-3) on their visit to the orthopedic clinic. Our primary outcome was at T-2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of anxiety</measure>
    <time_frame>Level of anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery</time_frame>
    <description>Anxiety was measured as baseline data on the pre-operative visit (24 hrs before surgery). It was also measured at two weeks post-discharge and at one month on the day of the visit to the orthopedic clinic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of coping</measure>
    <time_frame>Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery</time_frame>
    <description>Coping strategies of adolescents regarding their pain management were also measured pre-operatively (24 hrs before surgery), at two weeks and one month post-surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pain</condition>
  <condition>Scoliosis</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Guided imagery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Guided imagery intervention</intervention_name>
    <description>A 30-min DVD was developed which included general information on pain management as well as a section on guided imagery using sounds and images.</description>
    <arm_group_label>Guided imagery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 11 and 20 years old&#xD;
&#xD;
          -  Have undergone a posterior/anterior arthrodesis surgery for idiopathic scoliosis&#xD;
&#xD;
          -  Able to write and understand French&#xD;
&#xD;
          -  Requires a computer or DVD player at home.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with a moderate cognitive deficit or severe mental retardation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvie Le May, RN, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Ste-Justine Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>June 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>August 9, 2012</last_update_submitted>
  <last_update_submitted_qc>August 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Justine's Hospital</investigator_affiliation>
    <investigator_full_name>Sylvie Charette</investigator_full_name>
    <investigator_title>Clinical Nurse Specialist</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Scoliosis</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Cognitive-behavioral interventions</keyword>
  <keyword>Adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</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/NCT01663909
org study id: Scoliosis
nct id: NCT01663909
lead sponsor: 
has dmc: No
Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain
      management a complex task. Several studies have found out that pharmacological interventions
      alone were not enough to provide optimal pain management for these patients. The
      investigators developed a DVD on guided imagery, customized for teenagers, to help them cope
      better with their pain. The investigators believe that this type of intervention combined
      with their usual analgesic medication will help them to control their pain and foster
      rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Level of pain intensity
time frame: Level of pain intensity at two weeks after the surgery
description: Pain was measured before the patients left the hospital on their 7th postoperative day (T-1, time of discharge from hospital). It was measured again at two week post-discharge (T-2) and also at one month post-discharge (T-3) on their visit to the orthopedic clinic. Our primary outcome was at T-2.
measure: Level of anxiety
time frame: Level of anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery
description: Anxiety was measured as baseline data on the pre-operative visit (24 hrs before surgery). It was also measured at two weeks post-discharge and at one month on the day of the visit to the orthopedic clinic.
measure: Level of coping
time frame: Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery
description: Coping strategies of adolescents regarding their pain management were also measured pre-operatively (24 hrs before surgery), at two weeks and one month post-surgery.
arm group label: Standard care
arm group type: No Intervention
arm group label: Guided imagery
arm group type: Experimental
intervention type: Behavioral
intervention name: Guided imagery intervention
description: A 30-min DVD was developed which included general information on pain management as well as a section on guided imagery using sounds and images.
arm group label: Guided imagery
criteria: 
gender: All
minimum age: 11 Years
maximum age: 20 Years
healthy volunteers: No
last name: Sylvie Le May, RN, PhD
role: Study Director
affiliation: Université de Montréal
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Justine's Hospital
investigator full name: Sylvie Charette
investigator title: Clinical Nurse Specialist
mesh term: Scoliosis