The Effect of Standardizing Procedures for SC Injections of LMWH on Patients With CVD (LMWH)

September 10, 2025 updated by: CHEUNG Pui Yu Frankie, The Hong Kong Polytechnic University

The Effect of Standardizing Procedures for Subcutaneous Injections of Low-molecular-weight Heparin on Patients With Cardiovascular Diseases: A Cluster Randomized Controlled Trial

Improper subcutaneous administration of LMWH may cause complications at the injection site. Standardized protocol for subcutaneous LMWH injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • Recruiting
        • Hospital Authority, Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients who are in cardiac care units suffering from cardiovascular diseases prescribed with LMWH injections two times per day
  • Chinese

Exclusion Criteria:

  • cognitively impaired
  • unconscious
  • refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Control
The control group participants will receive the usual practice of subcutaneous LMWH injection administered by nurses.
Other: Active Control
Patients in the control group will receive the usual practice of subcutaneous LMWH injection administered by nurses.
Experimental: Standardized injection protocol
The intervention group participants will receive standardized LMWH injection administered by nurses.
Other: Standardized injection protocol
Nurses administer LMWH according to the standardized evidence-based protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bruising
Time Frame: 24 hours, 48 hours, 72 hours
The bruising diameter will be measured by a ruler and the incidence of bruising will be recorded.
24 hours, 48 hours, 72 hours
Pain
Time Frame: Immediately after injection, 24 hours, 48 hours, 72 hours
Patients' pain levels are assessed using the Verbal Descriptor Scale: 'severe pain,' 'moderate pain,' 'mild pain,' and 'no pain.' 'Severe pain' indicates the worst outcome, followed by 'moderate pain,' then 'mild pain,' with 'no pain' representing the best outcome.
Immediately after injection, 24 hours, 48 hours, 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Experience
Time Frame: Immediately after receiving the injection
a Patient Experience Surveys to evaluate their perceived nurse's attitude
Immediately after receiving the injection
Communicative Competence
Time Frame: Immediately before and after injection
Communicative Competence Scale consists of 36 items across five dimensions (General Competence, Empathy Affiliation/Support, Behavioural Flexibility, and Social Relaxation), using a 5-point Likert scales ranging from strongly agree to strongly disagree (coded from 1 to 5). Higher the score means worse the outcome.
Immediately before and after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Arkers Wong, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250301
  • CHEUNGPuiYu (Other Identifier: Hong Kong PolyU)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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