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

The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04513873
Enrollment
256
Registered
2020-08-14
Start date
2019-01-18
Completion date
2019-03-28
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and Anxiety of Children During Phlebotomy

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?

Interventions

DEVICEEquipment to divert the focus of children

The equipment was placed in an area where the children would be able to see easily during the blood collection process. It was turned on as soon as the children sat on to the chair where the process would take place to divert the focus of the children at the equipment.

Sponsors

Afyonkarahisar Health Sciences University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026