NCT07316036

Effect of Patterned Versus Plain Fixation on Pain During IV Therapy in Children

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pain
• Intravenous Therapy
• Kronik hastalık

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-20
• Completion: 2026-01-30
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

1 site across 1 country: Turkey (Türkiye)