Effectiveness of a Pictorial Flashcard Regarding Self-care of Peripheral Intravenous Cannula (PIVC) on Its Indwelling Time and Related Complications Among Inpatients

April 12, 2019 updated by: Rahul Ranjan, Institute of Liver and Biliary Sciences, India

A Study to Evaluate the Effectiveness of a Pictorial Flashcard Regarding Self-Care of Peripheral Intravenous Cannula (PIVC) on Its Indwelling Time and Related Complications Among Inpatients at ILBS, New Delhi

The study title is "A Study to evaluate the Effectiveness of a Pictorial Flashcard regarding Self-Care of Peripheral Intravenous Cannula (PIVC) on its indwelling time and related complications among inpatients at ILBS, New Delhi." and it aim to evaluate the Effectiveness of a Pictorial Flashcard regarding Self-Care of PIVC on its indwelling time and related complications among inpatients.

Study Overview

Detailed Description

Objectives of the Study

  1. To evaluate the Effectiveness of a Pictorial Flashcard regarding Self-Care of PIVC on its indwelling time and related complications among inpatients.
  2. To find out the association between indwelling time of PIVC with selected demographic and clinical variables.
  3. To find out the association between PIVC related complications with selected demographic and clinical variables.

Setting of the Study General wards of ILBS, New Delhi

Population Inpatients with PIVC

Sampling Technique Convenient sampling technique.

Data collection Data will be collected from the study subjects as well as from medical records. Subjects were taken from General wards of Institute of Liver and Biliary Sciences, New Delhi.

Methodology Research Approach: Quantitative research approach. Research Design: Quasi Experimental Research design (Post-test only comparison group Design) Sample size: 80 (40 in each group), finalize after power analysis

Data Analysis Method Descriptive statistics: Mean, frequency, percentage distribution and Standard Deviation Inferential Statistics: Chi Square, t- test ANOVA, RM-ANOVA and Man-Whitney U test.

Study Type

Interventional

Enrollment (Actual)

80

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 Locations

    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of liver and Biliary Sciences

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients who:

  • were conscious & oriented.
  • could understand Hindi or English.
  • were between the age group of 18 to 60 years.
  • were admitted in general wards and scheduled for PIVC insertion
  • received IV infusion and/or medication for at least 3 days (72 hours)

Exclusion Criteria

Patients who:

  • were on physical restraints
  • were on sedative drugs.
  • in whom PIVC was removed for the sole purpose of discharge before 72 hours.
  • had short admission period, i.e less than 72 hours

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pictorial flashcard
In the experimental group researcher explained self-care of PIVC using pictorial flashcard on one to one basis. Patients were explained Do's and Don'ts, they have to keep in mind during self-care. Doubts of the patients were also addressed simultaneously. After this a copy of pictorial flashcard was given to the subjects to be used in future (during PIVC in-situ). Time was noted and kept for observation till 72 hours or removal in between.
In the experimental group researcher explained self-care of PIVC using pictorial flashcard on one to one basis. Patients were explained Do's and Don'ts, they have to keep in mind during self-care or management. Doubts of the patients were also addressed simultaneously. After this a copy of pictorial flashcard was given to the subjects to be used in future (during PIVC in-situ). In control group, standard care was given as per the hospital protocol. After 24 hours/one day, PIVC was observed for presence of any complications such as Phlebitis, Infiltration, Pain, Blockage and Dislodgement using V.I.P. Score, Infusion nurses society infiltration scale, Universal pain assessment tool and PIVC Documentation Tool and need for PIVC removal was also assessed. After 72 hours PIVC removed (whatever applicable) site of PIVC was reassessed, reason for removal was recorded and indwelling time was noted.
No Intervention: Comparison Group
In control group, standard care was given as per the hospital protocol.Time was noted and kept for observation till 72 hours or removal in between.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Pictorial Flashcard on Indwelling time of Peripheral Intravenous Cannula (PIVC) among inpatients.
Time Frame: 72 hours

Effectiveness refers to the significant increase in indwelling time of PIVC and reduction in PIVC related complication after using pictorial flash card on self-care of PIVC which calculated in hours i.e. 72 hours.

Indwelling time refers to the time duration i.e. 72 hours between insertion and removal of PIVC.

72 hours
Adverse events (complications related to PIVC) in both groups.
Time Frame: 72 hours
Adverse events or complications related to PIVC refers to complications, such as Phlebitis, Infiltration, Pain,Blockage and Dislodgement which occurs on PIVC site during the indwelling time of PIVC i.e. within or till 72 hours.
72 hours

Collaborators and Investigators

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

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)

October 29, 2018

Primary Completion (Actual)

December 9, 2018

Study Completion (Actual)

December 9, 2018

Study Registration Dates

First Submitted

October 13, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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