Impact of the PIKSEC App on Intravenous Insertion Success, Pain, and Emotional Manifestation in Pediatric Patients: a Non-Randomized Controlled Trial
October 13, 2024 updated by: Yeliz Taşdelen, Zonguldak Bulent Ecevit University
The study employed a post-test non-randomized controlled trial to assess the impact of the PİKSEÇ (Peripheral Intravenous Catheter Selection) application on the success of peripheral intravenous catheter (PIVC) placement, as well as on the pain and emotional level scores of hospitalized preschool children aged 3-6 years.
In preschool children, aged 3-6 years, who were hospitalized, anxiety about losing body integrity is commonly observed.
Children tend to think that all the material inside their bodies can come out through a wound or hole during invasive procedures.
Therefore, it becomes crucial to reduce anxiety related to invasive procedures in children of this age group.
In this context, the study aimed to be conducted in preschool children.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
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
-
-
Center
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Karabük, Center, Turkey, 78000
- Karabük Educational and Research Hospital
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-
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
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being a child in the 3-6 age group
- PIVC to be inserted
- Parents volunteering their child to participate in the study and signing the consent form
- Parents are literate
Exclusion Criteria:
- Physical and mental disabilities,
- The parent has an obstacle to communication (being mentally stable, etc.)
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: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group
|
The pediatric unit's PIVC insertion process will be routinely performed in routine care.
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Experimental: PİKSEÇ group
|
In designing the PİKSEÇ application, the Turkish validity and reliability version of the 'Difficult Intravenous Access Score' and a literal translation of the miniMAGIC instructions were utilized. The application serves as a guideline for nurses during peripheral intravenous catheter insertion, taking into account parameters such as the patient's age, urgency status, anxiety, and vein characteristics, providing tailored suggestions. By utilizing the application, nurses can follow evidence-based guidelines more efficiently, ensuring a faster and more practical adherence to the PIVC intervention procedure, ultimately contributing to a safer peripheral intravenous catheter insertion process. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PIVC success rate at first insertion
Time Frame: From the day the first sample was included in the study to the day the last sample was included, an estimated 4 months.
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From the day the first sample was included in the study to the day the last sample was included, an estimated 4 months.
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Number of PIVC attempts
Time Frame: Starts with the first PIVC attempt in each sample and ends with the successful PIVC attempt, an estimated 15 minutes.. Can be between 1 and 4 attempts.
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Starts with the first PIVC attempt in each sample and ends with the successful PIVC attempt, an estimated 15 minutes.. Can be between 1 and 4 attempts.
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PIVC attempts duration
Time Frame: Measured with a stopwatch for 4 months.
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It starts with the attachment of the tourniquet during the first PIVC attempt and ends with the fixation of the PIVC.
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Measured with a stopwatch for 4 months.
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|
Wong-Baker Faces Pain Rating Scale Score during PIVC attempt
Time Frame: It starts with the attachment of the tourniquet during the first PIVC attempt and ends with the fixation of the PIVC, an estimated 2 minutes.
|
The Wong-Baker Faces Pain Rating Scale has a minimum score of 0 and a maximum score of 5.
An increase in score means an increase in pain.
|
It starts with the attachment of the tourniquet during the first PIVC attempt and ends with the fixation of the PIVC, an estimated 2 minutes.
|
|
Emotional Indicators Scale in Children Score during PIVC attempt
Time Frame: It starts with the attachment of the tourniquet during the first PIVC attempt and ends with the fixation of the PIVC, an estimated 2 minutes..
|
The scale has a minimum score of 5 and a maximum score of 25.
An increase in the score indicates a worsening of the emotional state.
|
It starts with the attachment of the tourniquet during the first PIVC attempt and ends with the fixation of the PIVC, an estimated 2 minutes..
|
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)
December 15, 2023
Primary Completion (Actual)
April 15, 2024
Study Completion (Actual)
April 15, 2024
Study Registration Dates
First Submitted
December 5, 2023
First Submitted That Met QC Criteria
December 29, 2023
First Posted (Actual)
January 2, 2024
Study Record Updates
Last Update Posted (Actual)
October 16, 2024
Last Update Submitted That Met QC Criteria
October 13, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEU-YTASDELEN-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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