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Cold Application on the Subcutaneous Injection

Primary Purpose

Injection Site Bruising, Bruising, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold application
Sponsored by
Yuksek Ihtisas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Injection Site Bruising focused on measuring bruising, cold application, haematoma, low molecular weight heparin, nursing, pain, subcutaneous injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: to receive LMWH (pre-filled syringe containing 40 mg enoxaparin sodium in 0.4 ml) treatment at least once a day not to have any visual or auditory disorders not to have any foreknown coagulation disorders to have platelet, PTT and international normalized ratio (INR) values within the normal limits for beginning enoxaparin sodium injections not to have any hematologic disorders or any bruising or injuries at the abdominal wall to receive no injections at the abdominal site, other than the enoxaparin sodium during the research protocol to will to participate in this study Exclusion Criteria: to be pregnant have bleeding in the injection site have pain at any site of their body prior to the injection have any incision, drain, scar tissue, lipodystrophy or infection symptoms at the abdominal site which hinder the application of injection not to will to participate in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Group with two-minute pre-injection application of cold

    Group with five-minute pre-injection application of cold

    Control group

    Arm Description

    Before applying the subcutaneous injection, cold application pack was applied on the injection site for two minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours.

    Before applying the subcutaneous injection, cold application pack was applied on the injection site for five minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours.

    Without applying any tools or processes, the low molecular weight heparin injection was applied in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours.

    Outcomes

    Primary Outcome Measures

    Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection.
    It was evaluated whether bruise occurred 2 times at 48th and 72nd hours after heparin injection.
    Compare of the bruise sizes change of the patients at 48th and 72nd hours.
    If bruise developed after heparin injection, its size was measured 2 times at 48th and 72nd hours and recorded.
    Compare of the Visual Analogue Scale pain scores of the patients
    The level of pain felt after the heparin injection administration was measured with the visual analogue scale. Visual Analogue Scale (VAS) was used to measure the extent of pain during the injection. VAS is widely used to measure the clinical symptoms such as pain, panic, depression, and fatigue. VAS consists of 100 mm on a horizontal line. On the scale "0" means no pain and "100" shows severe pain. The patients were asked to mark the extent of pain they had immediately after the subcutaneous injection on the scale with 'X'. The distance from "no pain" to the place that the patient has marked quantitatively represents the pain of the patient.

    Secondary Outcome Measures

    Occurrence of haematoma at 48th and 72nd hours after the heparin injection.
    Changes in hematoma formation were evaluated at 48 and 72 hours after heparin injection.

    Full Information

    First Posted
    December 22, 2022
    Last Updated
    March 4, 2023
    Sponsor
    Yuksek Ihtisas University
    Collaborators
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05771285
    Brief Title
    Cold Application on the Subcutaneous Injection
    Official Title
    The Effect of Cold Application on the Occurrence of Bruising, Hematoma and Pain in the Subcutaneous Low Molecular Weight Heparin Injection: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yuksek Ihtisas University
    Collaborators
    Saglik Bilimleri Universitesi

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare the effect of cold application at different periods of time on the occurrence of bruising, haematoma and pain in the subcutaneous low molecular weight heparin (LMWH) injected patients.
    Detailed Description
    The study was a single-blind randomised control trial. Patients were allocated randomly to three groups: (i) Cold was applied for two minutes before the injection in the first group (n=26); (ii) Cold was applied for 5 min before the injection in the second group (n=26); and (iii) control group (n=26). All participating patients were injected 40 mg enoxaparin sodium in 0.4 ml in the pre-filled syringes using standard LMWH injection protocol. Post-injection VAS (Visual Analogue Scale) assessment and assessment of the presence and size of bruise and haematoma were conducted at 48th and 72nd hours after the injections for all groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injection Site Bruising, Bruising, Pain
    Keywords
    bruising, cold application, haematoma, low molecular weight heparin, nursing, pain, subcutaneous injection

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group with two-minute pre-injection application of cold
    Arm Type
    Active Comparator
    Arm Description
    Before applying the subcutaneous injection, cold application pack was applied on the injection site for two minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours.
    Arm Title
    Group with five-minute pre-injection application of cold
    Arm Type
    Active Comparator
    Arm Description
    Before applying the subcutaneous injection, cold application pack was applied on the injection site for five minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Without applying any tools or processes, the low molecular weight heparin injection was applied in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours.
    Intervention Type
    Other
    Intervention Name(s)
    Cold application
    Intervention Description
    To evaluate the effect of cold application applied before subcutaneous low molecular weight heparin injection on post-injection pain, ecchymosis and hematoma formation.
    Primary Outcome Measure Information:
    Title
    Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection.
    Description
    It was evaluated whether bruise occurred 2 times at 48th and 72nd hours after heparin injection.
    Time Frame
    after 48th and 72nd hours from injection
    Title
    Compare of the bruise sizes change of the patients at 48th and 72nd hours.
    Description
    If bruise developed after heparin injection, its size was measured 2 times at 48th and 72nd hours and recorded.
    Time Frame
    after 48th and 72nd hours from injection
    Title
    Compare of the Visual Analogue Scale pain scores of the patients
    Description
    The level of pain felt after the heparin injection administration was measured with the visual analogue scale. Visual Analogue Scale (VAS) was used to measure the extent of pain during the injection. VAS is widely used to measure the clinical symptoms such as pain, panic, depression, and fatigue. VAS consists of 100 mm on a horizontal line. On the scale "0" means no pain and "100" shows severe pain. The patients were asked to mark the extent of pain they had immediately after the subcutaneous injection on the scale with 'X'. The distance from "no pain" to the place that the patient has marked quantitatively represents the pain of the patient.
    Time Frame
    after 1 minute from injection administration
    Secondary Outcome Measure Information:
    Title
    Occurrence of haematoma at 48th and 72nd hours after the heparin injection.
    Description
    Changes in hematoma formation were evaluated at 48 and 72 hours after heparin injection.
    Time Frame
    after 48th and 72nd hours from injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: to receive LMWH (pre-filled syringe containing 40 mg enoxaparin sodium in 0.4 ml) treatment at least once a day not to have any visual or auditory disorders not to have any foreknown coagulation disorders to have platelet, PTT and international normalized ratio (INR) values within the normal limits for beginning enoxaparin sodium injections not to have any hematologic disorders or any bruising or injuries at the abdominal wall to receive no injections at the abdominal site, other than the enoxaparin sodium during the research protocol to will to participate in this study Exclusion Criteria: to be pregnant have bleeding in the injection site have pain at any site of their body prior to the injection have any incision, drain, scar tissue, lipodystrophy or infection symptoms at the abdominal site which hinder the application of injection not to will to participate in this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cevahir İlkim BULDAK
    Organizational Affiliation
    ilkimbuldak@yiu.edu.tr
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cold Application on the Subcutaneous Injection

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