Effect of Patterned Versus Plain Fixation on Pain During IV Therapy in Children (P-FLACC)

The Effect of Patterned Versus Plain Fixation Materials on Pain and Physiological Parameters in Children Receiving Intravenous Therapy: A Randomized Two-Period Crossover Trial

The goal of this clinical trial is to learn whether using patterned fixation materials during intravenous therapy can reduce pain and affect physiological responses in children.

Children who regularly receive intravenous therapy will take part in this study. Each participant will receive both patterned and plain fixation materials on different treatment days. Pain levels will be measured using an observation-based pain scale, and oxygen saturation and pulse rate will be recorded before and after the procedure.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Intravenous Therapy; Kronik hastalık
• Intervention / Treatment: Device: Patterned fixation tape; Device: Plain fixation tape

Detailed Description

This study is a randomized two-period crossover clinical trial designed to examine whether patterned fixation materials used during intravenous (IV) catheter placement reduce pain and influence physiological responses in children. The trial focuses on children who regularly receive IV therapy for chronic conditions and aims to compare two commonly used fixation materials: patterned fixation tape and plain fixation tape.

Participants are randomly assigned to one of two sequences. In Sequence AB, children receive the patterned fixation material during their first IV procedure and the plain fixation material during their next scheduled IV procedure. In Sequence BA, children receive the plain fixation material first and the patterned fixation material during their next procedure. A washout period of at least one week naturally occurs between visits because children attend the day treatment unit weekly or every three weeks for routine therapy. This interval is considered sufficient to prevent carry-over effects, as the intervention is a short-term non-pharmacological distraction method.

During each IV procedure, pain is assessed using the FLACC behavioral pain scale by two independent observers, and physiological parameters (oxygen saturation and pulse rate) are measured one minute before and one minute after the procedure. Each child serves as their own control, allowing within-participant comparisons between the patterned and plain fixation conditions.

The primary objective of the study is to determine whether patterned fixation materials lower pain scores compared with plain fixation materials. Secondary objectives include examining whether patterned fixation materials lead to more favorable physiological responses during IV catheter insertion.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Meram
    • Konya, Meram, Turkey (Türkiye), 42000
      • Necmettin Erbakan Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:- Children aged between 3 and 12 years

• Children who regularly receive intravenous therapy for chronic conditions
• Ability of the child and parent/legal guardian to understand the study procedures
• Written informed consent obtained from the parent or legal guardian
• Assent obtained from the child when appropriate

Exclusion Criteria:

• - Presence of acute pain at the time of the procedure
• Diagnosis of conditions that may interfere with pain assessment, such as cerebral palsy or neuromuscular or peripheral nervous system disorders
• Requirement for more than one intravenous catheter insertion attempt during the procedure
• Withdrawal of consent by the child or parent/legal guardian

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patterned Fixation Material; Children receive intravenous catheter fixation using patterned fixation materials during routine intravenous therapy.	Device: Patterned fixation tape; Patterned fixation tape is applied to secure the intravenous catheter after insertion, with the patterned surface remaining visible to the child during the procedure.; Device: Plain fixation tape; Plain fixation tape is applied to secure the intravenous catheter after insertion using standard, non-patterned fixation materials.
Active Comparator: Plain Fixation Material; Children receive intravenous catheter fixation using standard plain fixation materials during routine intravenous therapy.	Device: Patterned fixation tape; Patterned fixation tape is applied to secure the intravenous catheter after insertion, with the patterned surface remaining visible to the child during the procedure.; Device: Plain fixation tape; Plain fixation tape is applied to secure the intravenous catheter after insertion using standard, non-patterned fixation materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity was assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational pain scale. The total score ranges from 0 to 10, with higher scores indicating more severe pain.	Immediately after intravenous fixation during each study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological parameters, Spo2	Oxygen saturation (SpO₂) measured before and after intravenous fixation.	Immediately before and immediately after each intervention period
Physiological parameters, heart rate	heart rate measured before and after intravenous fixation.	Immediately before and immediately after each intervention period

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): December 20, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: January 1, 2026
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: January 1, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: çocuklarda ağrı; desenli tespit malzemesi; non farmakolojik yöntemler; fizyolojik parametreler; ağrı puanı
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: NEU-IV-FLACC-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves pediatric patients and includes sensitive clinical information. The informed consent forms and ethical approval for this thesis project do not allow the sharing of identifiable or individual-level data with external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No