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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06186518
Enrollment
100
Registered
2024-01-02
Start date
2023-12-15
Completion date
2024-04-15
Last updated
2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERPİKSEÇ

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.

OTHERRoutine care

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

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Zonguldak Bulent Ecevit University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
PIVC success rate at first insertionFrom 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 attemptsStarts 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 durationMeasured with a stopwatch for 4 months.It starts with the attachment of the tourniquet during the first PIVC attempt and ends with the fixation of the PIVC.
Wong-Baker Faces Pain Rating Scale Score during PIVC attemptIt 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.
Emotional Indicators Scale in Children Score during PIVC attemptIt 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026