<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/NCT03233321</url>
  </required_header>
  <id_info>
    <org_study_id>774</org_study_id>
    <nct_id>NCT03233321</nct_id>
  </id_info>
  <brief_title>Effectiveness of Dry Cold Application on Pain and Bruise at the Subcutaneous Injection Site Among Patients Admitted in ICU</brief_title>
  <official_title>A Study to Assess the Effectiveness of Dry Cold Application on Pain Intensity and Bruise at the Subcutaneous Injection Site Among Patients Admitted in Selected Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maharishi Markendeswar University (Deemed to be University)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maharishi Markendeswar University (Deemed to be University)</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The study evaluate the effectiveness of dry cold application on pain intensity and bruise at&#xD;
      the subcutaneous injection site among patients admitted in medical I.C.U. Purposive sampling&#xD;
      technique was used to select 60 hospitalized patients (30 in experimental and 30 in&#xD;
      comparison group). Dry cold was applied to the subcutaneous injection site using ice bag&#xD;
      filled with crushed ice with half table spoon of salt for 20 minutes after the administration&#xD;
      of injection and no intervention was given in comparison group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Setting was randomized by lottery method. Subjects were selected by purposive sampling&#xD;
      technique. Self-introduction was given to the subjects. Rapport was developed with subjects.&#xD;
      Nature and purpose of the study was explained to the subjects. Subjects were assured about&#xD;
      the confidentiality of their responses and informed written consent was taken prior to the&#xD;
      data collection. Subjects in the experimental and comparison group were administered low&#xD;
      molecular weight heparin injection subcutaneously by the researcher itself. After&#xD;
      administration of subcutaneous injection of low molecular weight heparin, dry cold&#xD;
      application using ice bag (Crushed ice was filled in ice bag with ½ table spoon of salt and&#xD;
      then covered by clean linen to prevent moisture) was placed over the injection site for about&#xD;
      20 minutes in experimental group and no intervention was given in comparison group. Pain was&#xD;
      assessed using numerical pain rating scale after 20 minutes of subcutaneous injection in both&#xD;
      the groups (experimental and comparison). At 12 hr, 48 hr and 72 hr after the subcutaneous&#xD;
      injection, bruise was assessed in both the groups using bruise assessment scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Pain Assessment Scale</measure>
    <time_frame>20 minutes</time_frame>
    <description>To assess pain at subcutaneous injection site. It is a standardized and well established pain scale.&#xD;
Description of the tool: The 0-10 pain rating scale is a tool commonly used to describe the intensity of pain. The person is asked to identify how much pain he/she is having by choosing a number from 0(no pain) to 10 (worst pain). Pain scoring is further classified into none (0), mild(1-3), moderate (4-6 )and severe (7-10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bruise Assessment Scale</measure>
    <time_frame>12 hours</time_frame>
    <description>Bruise score was checked according to its length in terms of mm2, which was measured by bruise assessment scale. Bruise was checked at different time points i.e. 12 hrs, 48 hrs and 72 hrs after subcutaneous injection. The millimeter ruler was used to measure the size of the bruise as under:&#xD;
Scoring of bruise assessment scale is as follows:&#xD;
Bruise Assessment Scale&#xD;
&lt;2mm2 0&#xD;
2-5 mm2 1&#xD;
Above 5 mm2 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bruise Assessment Scale</measure>
    <time_frame>48 hours</time_frame>
    <description>Bruise score was checked according to its length in terms of mm2, which was measured by bruise assessment scale. Bruise was checked at different time points i.e. 12 hrs, 48 hrs and 72 hrs after subcutaneous injection. The millimeter ruler was used to measure the size of the bruise as under:&#xD;
Scoring of bruise assessment scale is as follows:&#xD;
Bruise Assessment Scale&#xD;
&lt;2mm2 0&#xD;
2-5 mm2 1&#xD;
Above 5 mm2 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bruise Assessment Scale</measure>
    <time_frame>72 hours</time_frame>
    <description>Bruise score was checked according to its length in terms of mm2, which was measured by bruise assessment scale. Bruise was checked at different time points i.e. 12 hrs, 48 hrs and 72 hrs after subcutaneous injection. The millimeter ruler was used to measure the size of the bruise as under:&#xD;
Scoring of bruise assessment scale is as follows:&#xD;
Bruise Assessment Scale&#xD;
&lt;2mm2 0&#xD;
2-5 mm2 1&#xD;
Above 5 mm2 2</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain</condition>
  <condition>Bruise</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 patients were selected in experimental group. Dry cold was applied to the subcutaneous injection site using ice bag filled with crushed ice with half table spoon of salt for 20 minutes after the administration of injection.Pain intensity was measured using numeric pain rating scale immediately after dry cold application and bruise size was assessed using bruise assessment scale after 12, 48 and 72 hrs of injection administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention was given. Pain intensity was measured using numeric pain rating after 20 minutes of subcutaneous injection and bruise size was assessed using bruise assessment scale after 12, 48 and 72 hrs of injection administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry cold application</intervention_name>
    <description>Dry cold application using ice bag (Crushed ice was filled in ice bag with ½ table spoon of salt and then covered by clean linen to prevent moisture) was placed over the injection site for about 20 minutes.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sub cutaneous injection (low molecular weight heparin)</intervention_name>
    <description>sub cutaneous injection (low molecular weight heparin) has been administered on injection site</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        admitted in medical intensive care unit between the age group of 18-75 yrs willing for&#xD;
        participation in the study receiving subcutaneous injection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        having altered sensorium suffering from any skin disease at injection site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Poonam Sheoran, PhD,Nursing</last_name>
    <role>Study Director</role>
    <affiliation>MM university, Mullana, Ambala, Haryana, India.</affiliation>
  </overall_official>
  <reference>
    <citation>Baglin T, Barrowcliffe TW, Cohen A, Greaves M; British Committee for Standards in Haematology. Guidelines on the use and monitoring of heparin. Br J Haematol. 2006 Apr;133(1):19-34. doi: 10.1111/j.1365-2141.2005.05953.x. No abstract available.</citation>
    <PMID>16512825</PMID>
  </reference>
  <reference>
    <citation>Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). Circulation. 2004 Aug 3;110(5):588-636. doi: 10.1161/01.CIR.0000134791.68010.FA. No abstract available. Erratum In: Circulation. 2005 Apr 19;111(15):2013.</citation>
    <PMID>15289388</PMID>
  </reference>
  <reference>
    <citation>Dehghani K, Najari Z, Dehghani H. Effect of subcutaneous Enoxaparin injection duration on bruising size in acute coronary syndrome patients. Iran J Nurs Midwifery Res. 2014 Nov;19(6):564-8.</citation>
    <PMID>25558251</PMID>
  </reference>
  <reference>
    <citation>Thomas O, Lybeck E, Strandberg K, Tynngard N, Schott U. Monitoring low molecular weight heparins at therapeutic levels: dose-responses of, and correlations and differences between aPTT, anti-factor Xa and thrombin generation assays. PLoS One. 2015 Jan 27;10(1):e0116835. doi: 10.1371/journal.pone.0116835. eCollection 2015.</citation>
    <PMID>25625201</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 15, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maharishi Markendeswar University (Deemed to be University)</investigator_affiliation>
    <investigator_full_name>Supreet Rupam</investigator_full_name>
    <investigator_title>Student, Msc nursing</investigator_title>
  </responsible_party>
  <keyword>Dry cold application</keyword>
  <keyword>Pain</keyword>
  <keyword>Bruise</keyword>
  <keyword>Subcutaneous injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ecchymosis</mesh_term>
    <mesh_term>Contusions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Dalteparin</mesh_term>
  </intervention_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/NCT03233321
org study id: 774
nct id: NCT03233321
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study evaluate the effectiveness of dry cold application on pain intensity and bruise at
      the subcutaneous injection site among patients admitted in medical I.C.U. Purposive sampling
      technique was used to select 60 hospitalized patients (30 in experimental and 30 in
      comparison group). Dry cold was applied to the subcutaneous injection site using ice bag
      filled with crushed ice with half table spoon of salt for 20 minutes after the administration
      of injection and no intervention was given in comparison group.
Setting was randomized by lottery method. Subjects were selected by purposive sampling
      technique. Self-introduction was given to the subjects. Rapport was developed with subjects.
      Nature and purpose of the study was explained to the subjects. Subjects were assured about
      the confidentiality of their responses and informed written consent was taken prior to the
      data collection. Subjects in the experimental and comparison group were administered low
      molecular weight heparin injection subcutaneously by the researcher itself. After
      administration of subcutaneous injection of low molecular weight heparin, dry cold
      application using ice bag (Crushed ice was filled in ice bag with ½ table spoon of salt and
      then covered by clean linen to prevent moisture) was placed over the injection site for about
      20 minutes in experimental group and no intervention was given in comparison group. Pain was
      assessed using numerical pain rating scale after 20 minutes of subcutaneous injection in both
      the groups (experimental and comparison). At 12 hr, 48 hr and 72 hr after the subcutaneous
      injection, bruise was assessed in both the groups using bruise assessment scale.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Numeric Pain Assessment Scale
time frame: 20 minutes
description: To assess pain at subcutaneous injection site. It is a standardized and well established pain scale.
Description of the tool: The 0-10 pain rating scale is a tool commonly used to describe the intensity of pain. The person is asked to identify how much pain he/she is having by choosing a number from 0(no pain) to 10 (worst pain). Pain scoring is further classified into none (0), mild(1-3), moderate (4-6 )and severe (7-10).
measure: Bruise Assessment Scale
time frame: 12 hours
description: Bruise score was checked according to its length in terms of mm2, which was measured by bruise assessment scale. Bruise was checked at different time points i.e. 12 hrs, 48 hrs and 72 hrs after subcutaneous injection. The millimeter ruler was used to measure the size of the bruise as under:
Scoring of bruise assessment scale is as follows:
Bruise Assessment Scale
<2mm2 0
2-5 mm2 1
Above 5 mm2 2
measure: Bruise Assessment Scale
time frame: 48 hours
description: Bruise score was checked according to its length in terms of mm2, which was measured by bruise assessment scale. Bruise was checked at different time points i.e. 12 hrs, 48 hrs and 72 hrs after subcutaneous injection. The millimeter ruler was used to measure the size of the bruise as under:
Scoring of bruise assessment scale is as follows:
Bruise Assessment Scale
<2mm2 0
2-5 mm2 1
Above 5 mm2 2
measure: Bruise Assessment Scale
time frame: 72 hours
description: Bruise score was checked according to its length in terms of mm2, which was measured by bruise assessment scale. Bruise was checked at different time points i.e. 12 hrs, 48 hrs and 72 hrs after subcutaneous injection. The millimeter ruler was used to measure the size of the bruise as under:
Scoring of bruise assessment scale is as follows:
Bruise Assessment Scale
<2mm2 0
2-5 mm2 1
Above 5 mm2 2
arm group label: Experimental group
arm group type: Experimental
description: 30 patients were selected in experimental group. Dry cold was applied to the subcutaneous injection site using ice bag filled with crushed ice with half table spoon of salt for 20 minutes after the administration of injection.Pain intensity was measured using numeric pain rating scale immediately after dry cold application and bruise size was assessed using bruise assessment scale after 12, 48 and 72 hrs of injection administration.
arm group label: Comparison group
arm group type: No Intervention
description: No intervention was given. Pain intensity was measured using numeric pain rating after 20 minutes of subcutaneous injection and bruise size was assessed using bruise assessment scale after 12, 48 and 72 hrs of injection administration.
intervention type: Other
intervention name: Dry cold application
description: Dry cold application using ice bag (Crushed ice was filled in ice bag with ½ table spoon of salt and then covered by clean linen to prevent moisture) was placed over the injection site for about 20 minutes.
arm group label: Experimental group
intervention type: Other
intervention name: sub cutaneous injection (low molecular weight heparin)
description: sub cutaneous injection (low molecular weight heparin) has been administered on injection site
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dr. Poonam Sheoran, PhD,Nursing
role: Study Director
affiliation: MM university, Mullana, Ambala, Haryana, India.
citation: Baglin T, Barrowcliffe TW, Cohen A, Greaves M; British Committee for Standards in Haematology. Guidelines on the use and monitoring of heparin. Br J Haematol. 2006 Apr;133(1):19-34. doi: 10.1111/j.1365-2141.2005.05953.x. No abstract available.
PMID: 16512825
citation: Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). Circulation. 2004 Aug 3;110(5):588-636. doi: 10.1161/01.CIR.0000134791.68010.FA. No abstract available. Erratum In: Circulation. 2005 Apr 19;111(15):2013.
PMID: 15289388
citation: Dehghani K, Najari Z, Dehghani H. Effect of subcutaneous Enoxaparin injection duration on bruising size in acute coronary syndrome patients. Iran J Nurs Midwifery Res. 2014 Nov;19(6):564-8.
PMID: 25558251
citation: Thomas O, Lybeck E, Strandberg K, Tynngard N, Schott U. Monitoring low molecular weight heparins at therapeutic levels: dose-responses of, and correlations and differences between aPTT, anti-factor Xa and thrombin generation assays. PLoS One. 2015 Jan 27;10(1):e0116835. doi: 10.1371/journal.pone.0116835. eCollection 2015.
PMID: 25625201
responsible party type: Principal Investigator
investigator affiliation: Maharishi Markendeswar University (Deemed to be University)
investigator full name: Supreet Rupam
investigator title: Student, Msc nursing
mesh term: Ecchymosis
mesh term: Contusions
mesh term: Heparin
mesh term: Heparin, Low-Molecular-Weight
mesh term: Tinzaparin
mesh term: Dalteparin