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

NCT03233321 | Completed DMC

• 1 other identifier: 774
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Bruise

Keywords

Dry cold application; Pain; Bruise; Subcutaneous injection

Outcome Measures

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).

  20 minutes

Secondary Outcomes (3)

• Bruise Assessment Scale

  12 hours

• Bruise Assessment Scale

  48 hours

• Bruise Assessment Scale

  72 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

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)

Comparison group

NO INTERVENTION

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

Dry cold application OTHER

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.

Experimental group

sub cutaneous injection (low molecular weight heparin) OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• having altered sensorium suffering from any skin disease at injection site

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Related Publications (4)

• 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 BACKGROUND

• 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.

  PMID: 15289388 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain; Contusions

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds, Nonpenetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Dr. Poonam Sheoran, PhD,Nursing

  MM university, Mullana, Ambala, Haryana, India.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student, Msc nursing

Study Record Dates

• First Submitted: July 15, 2017
• First Posted: July 28, 2017
• Study Start: November 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07