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Comparing Pain and Bruising of Subcutaneous Heparin Injection

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ClinicalTrials.gov Identifier: NCT01645774
Recruitment Status : Terminated
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):
Tayebe Pourghaznein, Mashhad University of Medical Sciences

Brief Summary:

Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study aimed to Identify and compare the effects of four different injection duration on pain and bruising associated with subcutaneous injection of heparin in 90 patients. Four injection methods were used for them:

A: 10s injections duration

B: 10s injection duration and waiting 10s before withdrawing the needle

C: 15s injection duration and waiting 5s before withdrawing the needle

D: 5s injection duration and waiting 15s before withdrawing the needle.

Bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was measured by pain visual analogue scale immediately after the injection. Data will be analyzed by SPSS.


Condition or disease Intervention/treatment Phase
Pain Bruising Procedure: 10s injections duration Procedure: 10s injection duration and waiting 10s before withdrawing the needle Procedure: 15s injection duration and waiting 5s before withdrawing the needle Procedure: 5s injection duration and waiting 15s before withdrawing the needle Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Study Start Date : January 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 10s injections duration
10s injections duration
Procedure: 10s injections duration
10s injections duration

Experimental: 10s injection duration , waiting 10s
10s injection duration and waiting 10s before withdrawing the needle
Procedure: 10s injection duration and waiting 10s before withdrawing the needle
10s injection duration and waiting 10s before withdrawing the needle

Experimental: 15s injection duration,waiting 5s
15s injection duration and waiting 5s before withdrawing the needle
Procedure: 15s injection duration and waiting 5s before withdrawing the needle
15s injection duration and waiting 5s before withdrawing the needle

Experimental: 5s injection duration , waiting 15s
5s injection duration and waiting 15s before withdrawing the needle
Procedure: 5s injection duration and waiting 15s before withdrawing the needle
5s injection duration and waiting 15s before withdrawing the needle




Primary Outcome Measures :
  1. decrease pain [ Time Frame: up to 6 months ]
    pain was measured by pain visual analogue scale immediately after the injection.

  2. bruising [ Time Frame: up to 6 months ]
    Bruising was measured by a flexible millimeter ruler 48h after each injection



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Ages Eligible for Study:   53 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclination to participate in the study; filling out the form of conscious satisfaction
  • Ability to answer the questions and determining the rate of pain
  • Not being affected by blood clotting difficulties, tissue damages, injuries, and bruises in the site of injection.

Exclusion Criteria:

  • Death,
  • Discharge

Responsible Party: Tayebe Pourghaznein, faculty member,MSc of Nursing, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01645774     History of Changes
Other Study ID Numbers: interventional
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: June 2012

Keywords provided by Tayebe Pourghaznein, Mashhad University of Medical Sciences:
subcutaneous injection heparin
injection duration
bruising pain
decrease pain
decrease bruising

Additional relevant MeSH terms:
Contusions
Wounds, Nonpenetrating
Wounds and Injuries
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action