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

Necmettin Erbakan University

Status: Active, not recruiting

Conditions: Pain; Intravenous Therapy; Kronik hastalık

Treatments: Device: Plain fixation tape; Device: Patterned fixation tape

Study type: Interventional

Funder types: Other

Identifiers

NCT07316036

NEU-IV-FLACC-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Patterned Fixation Material

Active Comparator group

Description:

Children receive intravenous catheter fixation using patterned fixation materials during routine intravenous therapy.

Treatment:

Device: Patterned fixation tape

Device: Plain fixation tape

Plain Fixation Material

Active Comparator group

Description:

Children receive intravenous catheter fixation using standard plain fixation materials during routine intravenous therapy.

Treatment:

Device: Patterned fixation tape

Device: Plain fixation tape