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CompletedNCT03233321Updated Jul 28, 2017

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

An interventional study of Dry cold application and sub cutaneous injection (low molecular weight heparin) in Pain and Bruise, sponsored by Maharishi Markendeswar University (Deemed to be University). Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-07-28.

Sponsored by Maharishi Markendeswar University (Deemed to be University) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain
  • Bruise

Keywords

  • Dry cold application
  • Pain
  • Bruise
  • Subcutaneous injection
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

having altered sensorium suffering from any skin disease at injection site

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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 · Other: sub cutaneous injection (low molecular weight heparin)

  • 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.

Interventions

  • OtherDry 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.

  • Othersub cutaneous injection (low molecular weight heparin)

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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 20 minutes

Secondary outcomes

  1. 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

    Time frame: 12 hours

  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

    Time frame: 48 hours

  3. 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

    Time frame: 72 hours

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 16512825 ↗
  • 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. PubMed 15289388 ↗
  • 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. PubMed 25558251 ↗
  • 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. PubMed 25625201 ↗
08

Registry details

Key details

Study ID
NCT03233321
Lead sponsor
Maharishi Markendeswar University (Deemed to be University)
Responsible party
Supreet Rupam (Student, Msc nursing, Maharishi Markendeswar University (Deemed to be University)) — Principal investigator
First posted
Jul 28, 2017
Start date
Nov 2015
Primary completion
Jan 2017
Completion
Jun 2017
Last update
Jul 28, 2017

Study contacts

Dr. Poonam Sheoran, PhD,Nursing
study director · MM university, Mullana, Ambala, Haryana, India.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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