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The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy

Not Applicable
Completed
Conditions
Pain and Anxiety of Children During Phlebotomy
Interventions
Device: Equipment to divert the focus of children
Registration Number
NCT04513873
Lead Sponsor
Afyonkarahisar Health Sciences University
Brief Summary

This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.

Detailed Description

The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
256
Inclusion Criteria
  • making a request for the phlebotomy
  • being in the 7-12 age group
  • having the consent of the parent
  • willing to participate in the research
  • with the history of invasive procedure
  • not using any medication with analgesic effect in the last 12 hours
  • without any communication barriers of either child or the parent
  • with a normal level of consciousness during the process
  • without the history of passing out during the phlebotomy
Exclusion Criteria
  • not being in the 7-12 age group
  • not having the consent of the parent
  • not willing to participate in the research
  • without the history of invasive procedure
  • had medication with analgesic effect in the last 12 hours
  • with communication barriers of either child or the parent
  • with an abnormal level of consciousness during the process
  • with the history of passing out during the phlebotomy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Equipment Intervention GroupEquipment to divert the focus of childrenThe intervention group had equipment that looks like a blood tube in front of them during the blood collection process to divert their attention from the blood collection process to the equipment. This equipment was with a fixed arm on the right and a moving arm on the left with a total height of 80 cm as well as a red light-emitting diode(LED) to stimulate the blood collection. It had some answers to common questions of parents as well as the key concerns of the children like " Will it hurt me?". The equipment was made a musical device by loading the most popular children's songs into its database.
Primary Outcome Measures
NameTimeMethod
Assessment of Children's Anxiety Level ChangeTwice ( Immediately after the procedure and 14 days after the procedure)

Children's Fear Scale is an instrument with five different face images changing from neutral (0= no fear) to most scared (4= with the most fear) to evaluate the scare level of the children during the procedure.

Secondary Outcome Measures
NameTimeMethod
Revised Face Pain Scale (FPS-R)Twice ( During the procedure and 5-10 minutes after the procedure)

The FPS-R is a scale to measure how children feel in their inner world than how their faces look. It is designed on the widely accepted 0-to-10 metric according to the chosen face. "0" equals "No pain" and "10" equals "Very much pain."

Trial Locations

Locations (1)

Manavgat State Hospital

🇹🇷

Antalya, Manavgat, Turkey

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