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

NCT07249723 | Completed

• 2 other identifiers: 18.11.20252209
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nursing Care; Pain Management; Anxiety; Children

Keywords

Acute pain; Distraction; Bubble blowing; Positive reinforcement; Acute pain; Distraction; Bubble blowing; Positive reinforcement

Outcome Measures

Primary Outcomes (2)

• Wong-Baker FACES Pain Rating Scale (WB-FACES)

  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)

  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 Outcomes (1)

• Visual Analog Scale (VAS)

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

Study Arms (3)

Bubble Blowing Group

EXPERIMENTAL

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

Positive Reinforcement Group

EXPERIMENTAL

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

Standard Procedure Blood Sampling Group

NO INTERVENTION

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.

Interventions

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").

Positive Reinforcement Group

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.

Bubble Blowing Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, İzmit, 41001, Turkey (Türkiye)

Location

Related Publications (9)

• Czech O, Wrzeciono A, Rutkowska A, Guzik A, Kiper P, Rutkowski S. Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jul 23;10(15):3248. doi: 10.3390/jcm10153248.

  PMID: 34362032 BACKGROUND

• Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.

  PMID: 2197679 BACKGROUND

• Yu Z, Zhou Y, Xu X, Lin L, Le Q, Gu Y. Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial. BMC Pediatr. 2023 Feb 3;23(1):58. doi: 10.1186/s12887-023-03855-z.

  PMID: 36737707 BACKGROUND

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 BACKGROUND

• Lawson SL, Hogg MM, Moore CG, Anderson WE, Osipoff PS, Runyon MS, Reynolds SL. Pediatric Pain Assessment in the Emergency Department: Patient and Caregiver Agreement Using the Wong-Baker FACES and the Faces Pain Scale-Revised. Pediatr Emerg Care. 2021 Dec 1;37(12):e950-e954. doi: 10.1097/PEC.0000000000001837.

  PMID: 31335787 BACKGROUND

• Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.

  PMID: 30362982 BACKGROUND

• Gerçeker, G.Ö., Ayar, D., Özdemir, E. Z., & Bektaş, M. (2018). Gaining of Children's state anxiety and Children's fear scale to Turkish language. E- Journal of Dokuz Eylul University Nursing Faculty, 11(1), 9-13. https://dergipark.org.tr/tr/pub/deuhfed/issue/46786/586670

  BACKGROUND

• Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21.

  PMID: 33485746 BACKGROUND

• Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.

  PMID: 35068011 BACKGROUND

MeSH Terms

Conditions

Agnosia; Anxiety Disorders; Acute Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (third party blinding- Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: April 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 15, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)