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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03730493
Other study ID # ILBS-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 29, 2018
Est. completion date December 9, 2018

Study information

Verified date April 2019
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 9, 2018
Est. primary completion date December 9, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
India Institute of Liver and Biliary Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of Pictorial Flashcard on Indwelling time of Peripheral Intravenous Cannula (PIVC) among inpatients. 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
Primary Adverse events (complications related to PIVC) in both groups. 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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