NCT05161416

Brief Summary

Active and passive distraction methods are frequently used in the nursing management of procedural pain in children. There are no studies comparing the effects of cartoon watching (passive) and bubble blowing (active) as distraction methods on pain, anxiety, and fear associated with venipuncture in children. This study aimed to compare the effects of bubble blowing (active distraction) and cartoon watching (passive distraction) techniques on pain, anxiety, and fear during venipuncture in children aged 6-8 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

December 5, 2021

Last Update Submit

September 2, 2024

Conditions

Keywords

NursingPain ManagementDistractionChildren

Outcome Measures

Primary Outcomes (3)

  • Pain assesed by Wong-Baker FACES

    The Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

    Procedure (during the venipuncture)

  • Anxiety assesed by Children's State Anxiety Scale

    The Children's State Anxiety Scale assesses children's anxiety. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.

    Procedure (during the venipuncture)

  • Fear by Children's Fear Scale

    The Child Fear Scale was used.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to 4 (extreme fear). Higher scores mean a worse outcome.

    Procedure (during the venipuncture)

Secondary Outcomes (3)

  • Pain assesed by Wong-Baker FACES

    After procedure (at 3rd minutes after the venipuncture)

  • Anxiety assesed by Children's State Anxiety Scale

    After procedure (at 3rd minutes after the venipuncture)

  • Fear by Children's Fear Scale

    After procedure (at 3rd minutes after the venipuncture)

Study Arms (2)

Bubble Group

EXPERIMENTAL

The children started to blow bubbles 3 minutes before the procedure. The procedure and the bubble blowing intervention were terminated simultaneously.

Behavioral: Bubble Blowing

Cartoon Group

EXPERIMENTAL

The children started to watch the cartoon 3 minutes before the procedure. The children were supported by their parents in holding the tablet. The procedure and the cartoon watching intervention were terminated simultaneously.

Behavioral: Cartoon Watching

Interventions

Bubble BlowingBEHAVIORAL

Active Distraction Methods

Bubble Group

Passive Distraction Methods

Cartoon Group

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child aged 6-8 years
  • Child with need or plan for venipuncture (antecubital fossa)

You may not qualify if:

  • Child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease
  • Child with use of opioids, narcotics, analgesics or sedatives in the last 24 hours before the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Hospital

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

Related Publications (1)

  • Ugucu G, Akdeniz Uysal D, Guzel Polat O, Artuvan Z, Polat Kulcu D, Aksu D, Gulgun Altintas M, Cetin H, Orekici Temel G. Effects of cartoon watching and bubble-blowing during venipuncture on pain, fear, and anxiety in children aged 6-8 years: A randomized experimental study. J Pediatr Nurs. 2022 Jul-Aug;65:e107-e114. doi: 10.1016/j.pedn.2022.03.016. Epub 2022 Apr 8.

MeSH Terms

Conditions

PainAnxiety DisordersAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The children and their parents were blinded to the groups. The principal researchers (R2, R3) were blinded to the research hypotheses. Data entry researchers (R4, R5, R6) were blinded (masked) to both research hypotheses and intervention groups. Data entries (R4, R5) were performed using the codes A and B, and shared with the researchers (R1, R7, R8) after statistical analyses were conducted and the research report was written.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2021

First Posted

December 17, 2021

Study Start

October 15, 2019

Primary Completion

March 2, 2020

Study Completion

March 2, 2020

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available due to ethical considerations.

Locations