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

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ClinicalTrials.gov Identifier: NCT03730493
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Rahul Ranjan, Institute of Liver and Biliary Sciences, India

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inpatient Facililty Diagnoses Behavioral: Teaching subjects regarding self-care of PIVC with Pictorial Flashcard. Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : October 29, 2018
Actual Primary Completion Date : December 9, 2018
Actual Study Completion Date : December 9, 2018
Arms and Interventions
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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.
 Behavioral: Teaching subjects regarding self-care of PIVC with 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 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730493


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Rahul Ranjan, Principal Investigator, Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03730493    
Other Study ID Numbers: ILBS-01
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No