Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03233321
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Supreet Rupam, Maharishi Markendeswar University

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.

Condition or disease Intervention/treatment Phase
Pain Bruise Other: Dry cold application Other: sub cutaneous injection (low molecular weight heparin) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bruises
Drug Information available for: Heparin

Arm Intervention/treatment
Experimental: Experimental group
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.
Other: Dry cold application
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.

Other: sub cutaneous injection (low molecular weight heparin)
sub cutaneous injection (low molecular weight heparin) has been administered on injection site

No Intervention: Comparison group
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.



Primary Outcome Measures :
  1. Numeric Pain Assessment Scale [ Time Frame: 20 minutes ]

    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 :
  1. Bruise Assessment Scale [ Time Frame: 12 hours ]

    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


  2. Bruise Assessment Scale [ Time Frame: 48 hours ]

    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


  3. Bruise Assessment Scale [ Time Frame: 72 hours ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233321


Sponsors and Collaborators
Maharishi Markendeswar University
Investigators
Layout table for investigator information
Study Director: Dr. Poonam Sheoran, PhD,Nursing MM university, Mullana, Ambala, Haryana, India.

Publications:
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. Erratum in: Circulation. 2005 Apr 19;111(15):2013.

Layout table for additonal information
Responsible Party: Supreet Rupam, Student, Msc nursing, Maharishi Markendeswar University
ClinicalTrials.gov Identifier: NCT03233321     History of Changes
Other Study ID Numbers: 774
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Supreet Rupam, Maharishi Markendeswar University:
Dry cold application
Pain
Bruise
Subcutaneous injection

Additional relevant MeSH terms:
Layout table for MeSH terms
Contusions
Ecchymosis
Wounds, Nonpenetrating
Wounds and Injuries
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action