The Effect of the PİKSEÇ App on Peripheral Intravenous Catheter Insertion on Success, Pain and Emotional Level in Children

Pain Clinical Trial

Official title:

The Effect of the PİKSEÇ App on Peripheral Intravenous Catheter Insertion on Success, Pain and Emotional Level in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186518
• Other study ID #: BEU-YTASDELEN-002
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2023
• Source: Zonguldak Bulent Ecevit University
• Contact: Yeliz Tasdelen
• Phone: +905435290540
• Email: tasdelenyeliz90[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.)

Related Conditions & MeSH terms

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

Intervention

Other:
• PIKSEÇ
In designing the PIKSEÇ 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
The pediatric unit's PIVC insertion process will be routinely performed in routine care.

Locations

Country	Name	City	State
Turkey	Karabük Educational and Research Hospital	Karabük	Center

Sponsors (2)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University	TUBITAK

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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..