- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03730493
Effectiveness of a Pictorial Flashcard Regarding Self-care of Peripheral Intravenous Cannula (PIVC) on Its Indwelling Time and Related Complications Among Inpatients
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives of the Study
- To evaluate the Effectiveness of a Pictorial Flashcard regarding Self-Care of PIVC on its indwelling time and related complications among inpatients.
- To find out the association between indwelling time of PIVC with selected demographic and clinical variables.
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
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New Delhi, Delhi, India, 110070
- Institute of liver and Biliary Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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