<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/NCT03307239</url>
  </required_header>
  <id_info>
    <org_study_id>103044</org_study_id>
    <nct_id>NCT03307239</nct_id>
  </id_info>
  <brief_title>Cold Application on Pain During Chest Tube Removal</brief_title>
  <official_title>Efficacy of Cold Application on Pain During Chest Tube Removal: A Randomized Controlled Trial : A CONSORT Compliant Article</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiayi Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiayi Christian Hospital</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>
      Abstract Objectives: Use of analgesics is the most common method to alleviate the pain&#xD;
      induced by chest tube removal (CTR), but patient response to medication can vary and may not&#xD;
      be achieved complete relaxation. This study was to determine the effectiveness of cold&#xD;
      application in combination with standard analgesic administration before CTR on CTR-induced&#xD;
      pain.&#xD;
&#xD;
      Methods: A prospective, randomized, single-blind, placebo sham-controlled study was&#xD;
      conducted. In addition to the same routine care, subjects in the experimental group (n = 30)&#xD;
      received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the&#xD;
      placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to&#xD;
      measured pain intensity before, immediately after, and 10 minutes after CTR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2014</start_date>
  <completion_date type="Actual">September 15, 2015</completion_date>
  <primary_completion_date type="Actual">September 15, 2015</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>
    <intervention_model_description>subjects in the experimental group received cold application of 600 g ice packs 15 min before CTR, whereas subjects in the sham group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>the researcher assigned participants to one of the two groups: cold application (experimental group) or tap water packs application (sham group) according the random allocation sequence.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>numerical rating scale (NRS)</measure>
    <time_frame>before cold application</time_frame>
    <description>the intensity of pain at the chest tube replacement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>numerical rating scale (NRS)</measure>
    <time_frame>immediately after chest tube removal</time_frame>
    <description>the intensity of pain at the chest tube removal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>numerical rating scale (NRS)</measure>
    <time_frame>10 minutes after chest tube removal</time_frame>
    <description>the intensity of pain at the chest tube removal</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chest Tube Removal</condition>
  <arm_group>
    <arm_group_label>cold application (experimental group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tap water packs application (sham group)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>subjects in the sham group (n = 30) received tap water packs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cold application</intervention_name>
    <description>We manufactured two ice packs (17 × 12 cm) with a combined weight of 600 g. The ice packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the ice packs was approximately 25 cm in diameter around the chest tube.&#xD;
For patients of the experimental group, they were received 15-minutes cold application.</description>
    <arm_group_label>cold application (experimental group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tap water packs application</intervention_name>
    <description>We manufactured two tap water packs (17 × 12 cm) with a combined weight of 600 g. The tap water packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the tap water packs was approximately 25 cm in diameter around the chest tube.&#xD;
For patients of the sham group, they were received 15-minutes tap water application.</description>
    <arm_group_label>tap water packs application (sham group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (a) age greater than 20 years, (b) single chest-tube insertion, (c) first-time&#xD;
             insertion of the chest tube, (d) ability to verbally report pain, (e) body mass index&#xD;
             of &lt; 30 kg/m2, and (f) normal vital signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cold urticaria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03307239
org study id: 103044
nct id: NCT03307239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Abstract Objectives: Use of analgesics is the most common method to alleviate the pain
      induced by chest tube removal (CTR), but patient response to medication can vary and may not
      be achieved complete relaxation. This study was to determine the effectiveness of cold
      application in combination with standard analgesic administration before CTR on CTR-induced
      pain.

      Methods: A prospective, randomized, single-blind, placebo sham-controlled study was
      conducted. In addition to the same routine care, subjects in the experimental group (n = 30)
      received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the
      placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to
      measured pain intensity before, immediately after, and 10 minutes after CTR.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: subjects in the experimental group received cold application of 600 g ice packs 15 min before CTR, whereas subjects in the sham group
primary purpose: Treatment
masking: Single (Participant)
masking description: the researcher assigned participants to one of the two groups: cold application (experimental group) or tap water packs application (sham group) according the random allocation sequence.
measure: numerical rating scale (NRS)
time frame: before cold application
description: the intensity of pain at the chest tube replacement
measure: numerical rating scale (NRS)
time frame: immediately after chest tube removal
description: the intensity of pain at the chest tube removal
measure: numerical rating scale (NRS)
time frame: 10 minutes after chest tube removal
description: the intensity of pain at the chest tube removal
arm group label: cold application (experimental group)
arm group type: Experimental
description: subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR
arm group label: tap water packs application (sham group)
arm group type: Sham Comparator
description: subjects in the sham group (n = 30) received tap water packs.
intervention type: Other
intervention name: cold application
description: We manufactured two ice packs (17 × 12 cm) with a combined weight of 600 g. The ice packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the ice packs was approximately 25 cm in diameter around the chest tube.
For patients of the experimental group, they were received 15-minutes cold application.
arm group label: cold application (experimental group)
intervention type: Other
intervention name: tap water packs application
description: We manufactured two tap water packs (17 × 12 cm) with a combined weight of 600 g. The tap water packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the tap water packs was approximately 25 cm in diameter around the chest tube.
For patients of the sham group, they were received 15-minutes tap water application.
arm group label: tap water packs application (sham group)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No