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Comparing Pain and Bruising of Subcutaneous Heparin Injection

Primary Purpose

Pain, Bruising

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

10s injections duration

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

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

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

About this trial

This is an interventional prevention trial for Pain focused on measuring subcutaneous injection heparin, injection duration, bruising pain, decrease pain, decrease bruising

Eligibility Criteria

53 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

10s injections duration

10s injection duration , waiting 10s

15s injection duration,waiting 5s

5s injection duration , waiting 15s

Arm Description

10s injections duration

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

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

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

Outcomes

Primary Outcome Measures

decrease pain

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

bruising

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01645774

First Posted

May 19, 2012

Last Updated

July 19, 2012

Sponsor

Mashhad University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01645774

Brief Title

Comparing Pain and Bruising of Subcutaneous Heparin Injection

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Terminated

Study Start Date

January 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Bruising

Keywords

subcutaneous injection heparin, injection duration, bruising pain, decrease pain, decrease bruising

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10s injections duration

Arm Type

Experimental

Arm Description

10s injections duration

Arm Title

10s injection duration , waiting 10s

Arm Type

Experimental

Arm Description

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

Arm Title

15s injection duration,waiting 5s

Arm Type

Experimental

Arm Description

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

Arm Title

5s injection duration , waiting 15s

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

10s injections duration

Intervention Description

10s injections duration

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

decrease pain

Description

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

Time Frame

up to 6 months

Title

bruising

Description

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

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

53 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Learn more about this trial

Comparing Pain and Bruising of Subcutaneous Heparin Injection

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