About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Body Positioning (Supine vs. Semi-Fowler's Position)
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
Duration of invasive procedure
Time required to complete the invasive procedure (intravenous catheter insertion or blood sampling).
Locations
Sponsors and contacts
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Izmir Tinaztepe University
Lead sponsor
Ege University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: