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

NCT ID: NCT07316036

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-01-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patterned Fixation Material

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

Group Type: ACTIVE_COMPARATOR

Patterned fixation tape

Intervention Type: DEVICE

Patterned fixation tape is applied to secure the intravenous catheter after insertion, with the patterned surface remaining visible to the child during the procedure.

Plain fixation tape

Intervention Type: DEVICE

Plain fixation tape is applied to secure the intravenous catheter after insertion using standard, non-patterned fixation materials.

Plain Fixation Material

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

Group Type: ACTIVE_COMPARATOR

Patterned fixation tape

Intervention Type: DEVICE

Patterned fixation tape is applied to secure the intravenous catheter after insertion, with the patterned surface remaining visible to the child during the procedure.

Plain fixation tape

Intervention Type: DEVICE

Plain fixation tape is applied to secure the intravenous catheter after insertion using standard, non-patterned fixation materials.

Interventions

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.

Intervention Type: DEVICE

Plain fixation tape

Plain fixation tape is applied to secure the intravenous catheter after insertion using standard, non-patterned fixation materials.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Müberra Ahsen Kalburcu

Pediatric Nurse, Graduate Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Necmettin Erbakan Üniversitesi

Konya, Meram, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

NEU-IV-FLACC-2025

Identifier Type: -

Identifier Source: org_study_id