Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Child Self-reported Pain: Wong-Baker Faces Pain Rating Scale |
Pain outcomes are assessed by child himself or herself using Wong-Baker Faces Pain Rating Scale. The scale includes 6 facial expressions with correlating numbers of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot), 10(hurts worst). Children pick a facial expression, that corresponds with their pain and see a number that matches it. The minimum value is 0 and the maximum value is 10, the higher score means a worse outcome (children having higher level of pain). |
Immediately after completing peripheral venipuncture. |
|
Primary |
Parents Reported Pain (Outcomes Assessor ): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) |
The effectiveness is analyzed by outcomes assessors using r-FLACC via video taken during the procedure. The outcomes assessor is blind for the study design. The r-FLACC is a tool which evaluates pain-related behavior on facial expression, leg movement, activity, cry and consolability. Total score of the scale is summed in range 0 to 10. 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.the higher scores mean a worse outcome. |
Immediately after completing all participants' interventions. |
|
Primary |
Observer Reported Pain (Parents): Revised Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (r-FLACC) |
Pain outcomes are assessed by parents using the r-FLACC scale. The r-FLACC is a tool which evaluates pain-related behavior on facial expression, leg movement, activity, cry and consolability. Total score of the scale is summed in range 0 to 10. 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain. The higher scores means a worse outcome |
Immediately after completing peripheral venipuncture. |
|
Secondary |
Concentration of Salivary Cortisol |
Physiological stress levels are measured by means of salivary cortisol as an indicator. The salivary samples (1-2 milliliter) are taken with sterile collection devices immediately after children reporting pain score. The salivary samples are immediately stored at -20? freezer. Cortisol levels are determined by human salivary cortisol ELISA Kit (Jianglai, Shanghai, China). This si no cut-off score and the higher scores means a worse outcomes |
Immediately after children reporting pain score |
|
Secondary |
Heart Rate |
Evaluate the physiological response (heart rate) caused by peripheral intravenous puncture. A portable recording pulse oximeter is connected to children's index finger. Heart rate (beats per minute) is measured and recorded. |
During the peripheral intravenous insertion procedure. |
|
Secondary |
Pulse Oximetry Saturation |
Evaluate the physiological response (pulse oximetry saturation) secondary to peripheral intravenous puncture. A portable recording pulse oximeter is connected to children's index finger. Pulse oximetry saturation(percentage)is measured and recorded. |
During the peripheral intravenous insertion procedure. |
|
Secondary |
Retaining Time of Intravenous Cannula |
Time (hours) from needle insertion to remove. |
When the needle is removed. |
|
Secondary |
Venipuncture Duration |
record how long is children's first venipuncture duration |
During children's first venipuncture |
|