Impact of the PIKSEC App on Intravenous Insertion Success, Pain, and Emotional Manifestation in Pediatric Patients: a Non-Randomized Controlled Trial

NCT06186518 | Completed

• 1 other identifier: BEU-YTASDELEN-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nurse's Role; Peripheral Venous Catheterization; Pain; Emotional Stress

Outcome Measures

Primary Outcomes (5)

• PIVC success rate at first insertion

  From the day the first sample was included in the study to the day the last sample was included, an estimated 4 months.

• Number of PIVC attempts

  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.

• PIVC attempts duration

  It starts with the attachment of the tourniquet during the first PIVC attempt and ends with the fixation of the PIVC.

  Measured with a stopwatch for 4 months.

• Wong-Baker Faces Pain Rating Scale Score during PIVC attempt

  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

  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..

Study Arms (2)

Control group

OTHER

Other: Routine care

PİKSEÇ group

EXPERIMENTAL

Other: PİKSEÇ

Interventions

PİKSEÇ OTHER

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.

PİKSEÇ group

Routine care OTHER

The pediatric unit's PIVC insertion process will be routinely performed in routine care.

Control group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Physical and mental disabilities,
• The parent has an obstacle to communication (being mentally stable, etc.)

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Karabük Educational and Research Hospital

Karabük, Center, 78000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Stress, Psychological

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse, RN

Model Details: The study will be conducted in the pediatric clinic of a training and research hospital. Initially, control group data will be gathered through the routine peripheral intravenous catheter placement practices within the service. Subsequently, data for the experimental group will be collected using the PİKSEÇ application.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 2, 2024
• Study Start: December 15, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-05

Locations

TU (1)