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Comparison of the Effect of Body Position (Supine and Semi-Fowler's) on Pain Level During Invasive Procedures in Children Aged 1-6 Years

NCT07547137 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2026-07-07

No results posted yet for this study

Summary

The purpose of this clinical trial is to find out whether different body positions (lying on the back or semi-sitting) can reduce pain in children aged 1-6 years during procedures such as blood sampling and intravenous line insertion.

This study will be conducted specifically with children aged 1-6 years and aims to determine which position is less painful for them.

The main questions this study aims to answer are:

Which position causes less pain: lying on the back (supine) or semi-sitting (Semi-Fowler's)? Does the level of pain experienced by children during the procedure change depending on the position? The researchers will compare children in these two different positions to evaluate which one results in less pain.

What is expected from participants:

Children will undergo routine hospital procedures such as blood sampling or intravenous line insertion.

During the procedure, children will be randomly placed in either the supine or semi-sitting position.

Researchers will observe and record the child's pain level using a special assessment scale.

This study aims to identify the most suitable position that may help children feel less pain during these procedures.

Conditions

  • FLACC Scale
  • Behavioral Pain Scale
  • Supine Position

Interventions

BEHAVIORAL

Body Positioning (Supine vs. Semi-Fowler's Position)

Participants will be assigned to one of two body positioning interventions during invasive procedures (intravenous catheter insertion or blood sampling). In the supine position group, children will be placed lying flat on their back. In the semi-Fowler's position group, children will be positioned in a semi-sitting posture with the upper body elevated at approximately 30-45 degrees. The assigned position will be maintained throughout the procedure. No additional pharmacological or non-pharmacological pain interventions will be applied beyond routine clinical practice. Pain levels will be assessed during the procedure using the FLACC (Face, Legs, Activity, Cry, Consolability) Behavioral Pain Scale.

Sponsors & Collaborators

  • Ege University

    collaborator OTHER

  • Izmir Tinaztepe University

    lead OTHER

Principal Investigators

  • Rabia GENÇ, PROF. DR · Ege University

  • AYSUN EKŞİOĞLU, Associate Professor · Ege University

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2026-11-01
Completion
2026-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07547137 on ClinicalTrials.gov