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

November 25, 2025 updated by: Sinem Yalnızoglu Caka, Kocaeli University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İzmit
      • Kocaeli, İzmit, Turkey (Türkiye), 41001
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bubble Blowing Group
Before the procedure, each child was given a bubble toy and instructed to blow bubbles throughout the procedure. The procedure duration was recorded with a stopwatch. Post-procedural pain and anxiety were assessed using standardized scales. A single-use bubble toy was used for each child.
Other: Bubble Blowing Group
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.
Experimental: Positive Reinforcement Group
Before the procedure, the researcher established communication with the child, and a short cognitive activity chosen by the child (e.g., counting numbers, word game) was implemented throughout the procedure. The parent provided physical and verbal support to the child. After the procedure, the child received verbal positive reinforcement.
Other: Positive Reinforcement Group
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").
No Intervention: Standard Procedure Blood Sampling Group
Children in the control group underwent the standard blood sampling procedure in accordance with routine clinical practice. Outcome measurements were conducted after the procedure. Once data collection was completed, children in this group also received verbal feedback. All measurements were performed immediately before and after venipuncture. A single-needle insertion technique was used, and all blood draws were performed by the same pediatric nurse, who was permanently assigned to the unit, to ensure procedural standardization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.
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.
A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18.11.2025
  • 2209 (TÜBİTAK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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