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Effectiveness of Dry Cold Application on Pain and Bruise at the Subcutaneous Injection Site Among Patients Admitted in ICU

Primary Purpose

Pain, Bruise

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry cold application
sub cutaneous injection (low molecular weight heparin)
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Dry cold application, Pain, Bruise, Subcutaneous injection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

admitted in medical intensive care unit between the age group of 18-75 yrs willing for participation in the study receiving subcutaneous injection

Exclusion Criteria:

having altered sensorium suffering from any skin disease at injection site

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group

    Comparison group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Numeric Pain Assessment Scale
    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).

    Secondary Outcome Measures

    Bruise Assessment Scale
    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
    Bruise Assessment Scale
    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
    Bruise Assessment Scale
    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

    Full Information

    First Posted
    July 15, 2017
    Last Updated
    July 27, 2017
    Sponsor
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03233321
    Brief Title
    Effectiveness of Dry Cold Application on Pain and Bruise at the Subcutaneous Injection Site Among Patients Admitted in ICU
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharishi Markendeswar University (Deemed to be University)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Bruise
    Keywords
    Dry cold application, Pain, Bruise, Subcutaneous injection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm 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 Title
    Comparison group
    Arm Type
    No Intervention
    Arm 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(s)
    Dry cold application
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    sub cutaneous injection (low molecular weight heparin)
    Intervention Description
    sub cutaneous injection (low molecular weight heparin) has been administered on injection site
    Primary Outcome Measure Information:
    Title
    Numeric Pain Assessment Scale
    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).
    Time Frame
    20 minutes
    Secondary Outcome Measure Information:
    Title
    Bruise Assessment Scale
    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
    Time Frame
    12 hours
    Title
    Bruise Assessment Scale
    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
    Time Frame
    48 hours
    Title
    Bruise Assessment Scale
    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
    Time Frame
    72 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: admitted in medical intensive care unit between the age group of 18-75 yrs willing for participation in the study receiving subcutaneous injection Exclusion Criteria: having altered sensorium suffering from any skin disease at injection site
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr. Poonam Sheoran, PhD,Nursing
    Organizational Affiliation
    MM university, Mullana, Ambala, Haryana, India.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16512825
    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.
    Results Reference
    background
    PubMed Identifier
    15289388
    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.
    Results Reference
    background
    PubMed Identifier
    25558251
    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.
    Results Reference
    background
    PubMed Identifier
    25625201
    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.
    Results Reference
    background

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    Effectiveness of Dry Cold Application on Pain and Bruise at the Subcutaneous Injection Site Among Patients Admitted in ICU

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