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 | Not Yet Recruiting DMC

• 1 other identifier: 26-2.1T/75
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

FLACC scale, behavioral pain scale, positioning, supine position, semi-Fowler's position; behavioral pain scale; supine position; positioning

Outcome Measures

Primary Outcomes (2)

• Pain level during invasive procedure (FLACC score)

  Pain levels will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) Behavioral Pain Scale during invasive procedures. This scale consists of five items: facial expression (Face), leg movements (Legs), overall activity (Activity), crying (Cry), and consolability (Consolability). Each item is scored between 0 and 2 (minimum 0, maximum 2). The total scale score ranges from 0 to 10 (minimum 0, maximum 10). Higher scores indicate a worse condition (e.g., greater pain or discomfort).

  During the procedure

• Duration of invasive procedure

  Time required to complete the invasive procedure (intravenous catheter insertion or blood sampling).

  During the procedure

Interventions

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

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.

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1-6 years presenting to the pediatric emergency department of a hospital in the Aegean region for invasive procedures (intravenous catheter insertion or blood sampling), who meet the inclusion criteria and whose parents provide written informed consent.

You may qualify if:

• Children aged 1-6 years
• Children presenting to the emergency department for invasive procedures (intravenous catheter insertion)
• Children whose parents have provided written informed consent
• Children without any chronic illness
• Children undergoing only invasive procedures such as intravenous catheter insertion or blood sampling
• Children not using analgesics regularly

You may not qualify if:

• Children with chronic pain or those using analgesics
• Children outside the 1-6 years age range
• Children with neurological or psychiatric disorders
• Children with physical disabilities that prevent appropriate positioning for the invasive procedure
• Children whose parents do not provide consent for participation

Sponsors & Collaborators

• Izmir Tinaztepe University: lead
• Ege University: collaborator

MeSH Terms

Conditions

Deception

Interventions

Posture

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rabia GENÇ, PROF. DR

  Ege University

  STUDY DIRECTOR

• AYSUN EKŞİOĞLU, Associate Professor

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Akyar, LECTURER

CONTACT

+905538507280; ayse.akyar@tinaztepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share