Skip to main content
OpenTrials
Completed

NCT Number: NCT04513873

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain and Anxiety of Children During Phlebotomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manavgat State Hospital

Antalya, Manavgat, 07600, Turkey (Türkiye)

About this study

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?"

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Equipment to divert the focus of children

Device

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.

Primary outcomes

  1. Assessment of Children's Anxiety Level Change

    Time frame: Twice ( 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 outcomes

  1. Revised Face Pain Scale (FPS-R)

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2020
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.