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Completed

NCT Number: NCT07249723

Comparison of the Effectiveness of Two Active Distraction Techniques During Venipuncture in Children

This study was conducted to compare the effects of two active distraction methods-bubble blowing and a material-free cognitive distraction/positive reinforcement technique-applied during venous blood sampling on pain, fear, and anxiety levels in children aged 7-12 years.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, İzmit, 41001, Turkey (Türkiye)

About this study

Distraction is an effective non-pharmacological nursing intervention used to reduce pain, fear, and anxiety in children during invasive procedures. This approach aims to decrease the child's emotional distress by diverting attention away from the perceived threat.

In particular, among children aged 7-12 years, procedure-related fear and avoidance behaviors may increase due to the impact of previous medical experiences; therefore, there is a need for comparative evaluation of effective distraction strategies tailored to this age group. While sensory-kinesthetic methods such as bubble blowing promote active participation, material-free cognitive techniques can be implemented in any setting and offer easily accessible options. However, studies directly comparing these methods remain limited.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged between 7 and 12 years,
  • Literate (able to read and write),
  • Having no diagnosed visual, hearing, intellectual, or neurological disorder,
  • With no history of analgesic, sedative, or narcotic use within 24 hours prior to admission,
  • Children who, together with their parent, volunteered to participate.

Exclusion criteria

  • Children who do not meet the inclusion criteria,
  • Children or parents who wish to withdraw from the study at any stage,
  • Children from whom a blood sample could not be obtained with a single venipuncture attempt.

Treatment and study plan

Bubble Blowing Group

Other

In the Bubble Blowing Group, children were given a bubble toy during the procedure and asked to blow bubbles. This method, which requires active motor participation, was used to divert the children's attention away from the stress of the procedure.

Positive Reinforcement Group

Other

In the Positive Reinforcement Group, children performed a non-material cognitive activity of their choice during the procedure (such as counting, reciting a short poem/song, or a word game). At the end of the procedure, verbal positive reinforcement was provided (e.g., "Well done," "You were very brave").

Primary outcomes

  1. Wong-Baker FACES Pain Rating Scale (WB-FACES)

    Time frame: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.

    Developed by Wong and Baker (1988), this scale assesses pain intensity in children aged 3-18 years based on facial expressions, using a 0-5 scoring system. Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale (0-10; higher scores indicate worse pain).

  2. Children's Fear and Anxiety Scale (CFS)

    Time frame: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.

    Developed by McMurtry et al. (2011) and adapted into Turkish by Gerçeker et al. (2018), this scale evaluates fear and anxiety during the procedure on a 0-4 rating scale. 0-10; higher scores indicate greater fear and anxiety.

Secondary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.

    The VAS is a valid and reliable scale that measures pain intensity on a 0-10 cm linear line (Wewers & Lowe, 1990). All scales were administered before and after the procedure.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Comparison of the Effectiveness of Two Active Distraction Methods in Reducing Pain, Fear, and Anxiety in Children Undergoing Venous Blood Sampling

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Dec 3, 2025

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.

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