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Completed

NCT Number: NCT06186518

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

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.

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Key information

Conditions

Nurse's Role Behavior Behavioral Symptoms Emotional Stress Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Peripheral Venous Catheterization Signs and Symptoms Stress, Psychological

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karabük Educational and Research Hospital

Karabük, Center, 78000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Routine care

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. PIVC attempts duration

    Time frame: Measured 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 2, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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