Comparing Pain and Bruising of Subcutaneous Heparin Injection

NCT01645774 | Terminated Phase 2 DMC

• 1 other identifier: interventional
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Bruising

Keywords

subcutaneous injection heparin; injection duration; bruising pain; decrease pain; decrease bruising

Outcome Measures

Primary Outcomes (2)

• decrease pain

  pain was measured by pain visual analogue scale immediately after the injection.

  up to 6 months

• bruising

  Bruising was measured by a flexible millimeter ruler 48h after each injection

  up to 6 months

Study Arms (4)

10s injections duration

EXPERIMENTAL

10s injections duration

Procedure: 10s injections duration

10s injection duration , waiting 10s

EXPERIMENTAL

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

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

15s injection duration,waiting 5s

EXPERIMENTAL

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

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

5s injection duration , waiting 15s

EXPERIMENTAL

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

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

Interventions

10s injections duration PROCEDURE

10s injections duration

10s injections duration

10s injection duration and waiting 10s before withdrawing the needle PROCEDURE

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

10s injection duration , waiting 10s

15s injection duration and waiting 5s before withdrawing the needle PROCEDURE

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

15s injection duration,waiting 5s

5s injection duration and waiting 15s before withdrawing the needle PROCEDURE

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

5s injection duration , waiting 15s

Eligibility Criteria

• Age: 53 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Death,
• Discharge

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

MeSH Terms

Conditions

Pain; Contusions

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: faculty member,MSc of Nursing

Study Record Dates

• First Submitted: May 19, 2012
• First Posted: July 20, 2012
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 20, 2012

Record last verified: 2012-06