Comparison of the Effect of Body Position (Supine and Semi-Fowler's) on Pain Level During Invasive Procedures in Children Aged 1-6 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Body Positioning (Supine vs. Semi-Fowler's Position).
- Who it may be relevant to
- Registry conditions: FLACC Scale, Behavioral Pain Scale, Supine Position. Basic parameters: 1 year — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COMPARİSON OF THE EFFECT OF BODY POSİTİON (SUPİNE AND SEMİ-FOWLER'S) ON PAİN LEVEL DURİNG INVASİVE PROCEDURES İN CHİLDREN AGED 1-6 YEARS
Overview
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.
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.
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-pharmacol
Primary outcome measures
- Pain level during invasive procedure (FLACC score) [Time frame: During the procedure]
- Duration of invasive procedure [Time frame: During the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07547137 · 26-2.1T/75