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Comparing Pain and Bruising of Subcutaneous Heparin Injection

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Tayebe Pourghaznein, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01645774
First received: May 19, 2012
Last updated: July 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • decrease pain [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    pain was measured by pain visual analogue scale immediately after the injection.

  • bruising [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Bruising was measured by a flexible millimeter ruler 48h after each injection


Enrollment: 90
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   53 Years to 69 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: May 19, 2012
Last Updated: July 19, 2012
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Contusions
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on May 19, 2013