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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-6
SponsorIzmir Tinaztepe University

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
During the procedure
2

Duration of invasive procedure

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

Time frame
During the procedure

Secondary outcomes

Other outcomes

Locations

This trial has no 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: