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

NCT07316036 | Active Not Recruiting

• 1 other identifier: NEU-IV-FLACC-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Intravenous Therapy; Kronik hastalık

Keywords

çocuklarda ağrı; desenli tespit malzemesi; non farmakolojik yöntemler; fizyolojik parametreler; ağrı puanı

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Physiological parameters, Spo2

  Immediately before and immediately after each intervention period

• Physiological parameters, heart rate

  Immediately before and immediately after each intervention period

Study Arms (2)

Patterned Fixation Material

ACTIVE COMPARATOR

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

Device: Patterned fixation tape; Device: Plain fixation tape

Plain Fixation Material

ACTIVE COMPARATOR

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

Device: Patterned fixation tape; Device: Plain fixation tape

Interventions

Patterned fixation tape 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.

Patterned Fixation Material; Plain Fixation Material

Plain fixation tape DEVICE

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

Patterned Fixation Material; Plain Fixation Material

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan Üniversitesi

Konya, Meram, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was applied because the intervention involved visibly different fixation materials (patterned versus plain), making blinding of participants and healthcare providers not feasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Nurse, Graduate Researcher

Model Details: This study uses a two-period randomized crossover design. Participants are assigned to one of two sequences (patterned fixation first, then plain; or plain fixation first, then patterned). Each child receives both interventions on different treatment days, serving as their own control.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 5, 2026
• Study Start: April 1, 2025
• Primary Completion: December 20, 2025
• Study Completion: January 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)