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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03233321
Enrollment
60
Registered
2017-07-28
Start date
2015-11-30
Completion date
2017-06-30
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruise, Pain

Keywords

Dry cold application, Pain, Bruise, Subcutaneous injection

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.

Interventions

OTHERsub cutaneous injection (low molecular weight heparin)

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

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.

Sponsors

Maharishi Markendeswar University (Deemed to be University)
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

having altered sensorium suffering from any skin disease at injection site

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Assessment Scale20 minutesTo 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

MeasureTime frameDescription
Bruise Assessment Scale12 hoursBruise 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026