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

COMPARİSON OF THE EFFECT OF BODY POSİTİON (SUPİNE AND SEMİ-FOWLER'S) ON PAİN LEVEL DURİNG INVASİVE PROCEDURES İN CHİLDREN AGED 1-6 YEARS

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Supine Position; FLACC Scale; Behavioral Pain Scale
• Intervention / Treatment: Behavioral: Body Positioning (Supine vs. Semi-Fowler's Position)

Detailed Description

Invasive medical procedures performed in pediatric emergency departments (such as intravenous catheter insertion) may cause significant pain and distress in children. The pain experienced during such procedures can negatively affect both the physical and psychological well-being of children. Pain perception may vary depending on factors such as the child's age, developmental level, previous experiences, and the position in which the procedure is performed. Accurate assessment of pain is particularly challenging in children aged 1-6 years due to their limited communication skills. In this age group, behavioral observation-based pain assessment tools are widely used. The FLACC (Face, Legs, Activity, Cry, Consolability) scale is a behavioral assessment tool developed for children aged 2 months to 7 years, with established validity and reliability. Recent systematic reviews support the reliability of this scale across various clinical settings.

This study is designed as a quantitative, prospective, randomized controlled experimental study to evaluate the effect of body position on pain levels during invasive procedures (blood sampling and intravenous catheter insertion) in children aged 1-6 years. The study will be conducted in the pediatric emergency department of a hospital located in the Aegean region, and the study population will consist of children aged 1-6 years who present to this unit and require invasive procedures.

The sample will consist of a total of 64 children who meet the inclusion criteria and whose parents provide written informed consent. After enrollment, participants will be assigned to two groups using a simple randomization method. The randomization process will be carried out using computer-generated random numbers or the sealed envelope method to ensure impartiality. Each participant will be assigned according to a pre-generated randomization list, thereby minimizing selection bias. As a result, children will be equally divided into two groups, with 32 children in each group:

Supine position group Semi-Fowler's (semi-sitting) position group

Children aged 1-6 years who require invasive procedures, have no chronic illness, do not use regular analgesics, and whose parents provide consent will be included in the study. Children with chronic pain, neurological or psychiatric disorders, physical conditions preventing appropriate positioning, or without parental consent will be excluded.

Data will be collected by the researchers through face-to-face observation and interviews in the pediatric emergency department. Two main instruments will be used for data collection: a Descriptive Information Form developed by the researchers and the FLACC (Face, Legs, Activity, Cry, Consolability) Behavioral Pain Assessment Scale, which is a valid and reliable tool for assessing pain in children. During the procedure, children's pain levels will be assessed based on direct observation and recorded in a standardized manner for each participant.

During the study, invasive procedures will be performed according to the position determined by randomization, and pain assessment will be conducted during the procedure. The collected data will be anonymized and coded, with no personal identifying information recorded. All data will be stored in accordance with confidentiality principles. The coding key will be kept only by the principal investigator and will not be shared with third parties.

After data collection, the data will be transferred to an electronic environment and analyzed using appropriate statistical software (SPSS). Descriptive statistics will be calculated first, followed by normality tests. Depending on the data distribution, either the independent samples t-test or the Mann-Whitney U test will be used to compare the two groups. The level of statistical significance will be set at p < 0.05.

The study will be conducted within the specified time frame after obtaining ethical approval, and all processes will be carried out in strict accordance with ethical principles, participant rights, and data security. This study aims to determine the position that causes less pain during invasive procedures in children.

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: Ayşe Akyar, LECTURER; Phone Number: +905538507280; Email: ayse.akyar@tinaztepe.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Izmir Tinaztepe University
• Collaborators: Ege University
• Investigators: Principal Investigator: AYSUN EKŞİOĞLU, Associate Professor, Ege University; Study Director: Rabia GENÇ, PROF. DR, Ege University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: supine position; positioning; behavioral pain scale; FLACC scale, behavioral pain scale, positioning, supine position, semi-Fowler's position
• Additional Relevant MeSH Terms: Behavior; Social Behavior; Deception; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Posture
• Other Study ID Numbers: 26-2.1T/75

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be publicly available. All collected data will be anonymized and used only for the purposes of this study. Data confidentiality will be strictly maintained in accordance with ethical and institutional guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No