Clinical trial NCT06186518: Impact of the PIKSEC App on Intravenous Insertion Success, Pain, and Emotional Manifestation in Pediatric Patients: a Non-Randomized Controlled Trial
Official title: Impact of the PIKSEC App on Intravenous Insertion Success, Pain, and Emotional Manifestation in Pediatric Patients: a Non-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Peripheral Venous Catheterization
Pain
Emotional Stress
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: PIVC success rate at first insertion
timeFrame: From the day the first sample was included in the study to the day the last sample was included, an estimated 4 months.
measure: Number of PIVC attempts
timeFrame: 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.
measure: PIVC attempts duration
timeFrame: Measured with a stopwatch for 4 months.
measure: Wong-Baker Faces Pain Rating Scale Score during PIVC attempt
timeFrame: 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.
measure: Emotional Indicators Scale in Children Score during PIVC attempt
timeFrame: 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..
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabük Educational and Research Hospital
state: Center
Study officials:
References: