NCT03730493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

October 13, 2018

Last Update Submit

April 12, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Pictorial flashcard

EXPERIMENTAL

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.

Comparison Group

NO INTERVENTION

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.

Interventions

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.

Pictorial flashcard

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2018

First Posted

November 5, 2018

Study Start

October 29, 2018

Primary Completion

December 9, 2018

Study Completion

December 9, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations