NCT06371599

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 watching cartoon (passive) and playing game (active) as distraction methods on pain and fear associated with peripheral intravenous cannula placement in children aged 6-9 years. This study aimed to compare the effects of playing game (active distraction) and watching cartoon (passive distraction) techniques on pain and fear during peripheral intravenous cannula placement in children aged 6-9 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2024

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

April 14, 2024

Last Update Submit

February 7, 2026

Conditions

Keywords

painfearchildren

Outcome Measures

Primary Outcomes (2)

  • 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).

    during the the peripheral intravenous cannula placement

  • 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.

    during the the peripheral intravenous cannula placement

Secondary Outcomes (2)

  • Pain assesed by Wong-Baker FACES

    at 3rd minutes after the the peripheral intravenous cannula placement

  • Fear by Children's Fear Scale

    at 3rd minutes after the the peripheral intravenous cannula placement

Study Arms (2)

Playing game

EXPERIMENTAL

The children will be asked which game they want to play before the procedure. They will start to play the game 3 minutes before the procedure.

Behavioral: Playing game

Watching cartoon

ACTIVE COMPARATOR

The children will be asked which cartoon they want to watch before the procedure. They will start to watch the cartoon 3 minutes before the procedure.

Behavioral: Watching cartoon

Interventions

Playing gameBEHAVIORAL

Active Distraction Methods

Playing game

Passive Distraction Methods

Watching cartoon

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child aged 6-9 years
  • Child with need or plan for the peripheral intravenous cannula placement (antecubital fossa of arm, superficial dorsal venous of hand)

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

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

Related Publications (1)

  • Uysal DA, Polat OG, Ugucu G, Karakul A, Olcay AZ, Tuzun O, Yigit R. A comparison of watching cartoons versus playing games as a distraction method on pain and fear of pain during peripheral intravenous cannula placement in children aged 6-9 years: A randomized experimental study. J Pediatr Nurs. 2025 Jan-Feb;80:161-166. doi: 10.1016/j.pedn.2024.11.023. Epub 2024 Nov 30.

MeSH Terms

Conditions

Pain, ProceduralPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guzide UGUCU, PhD, MScN

    Mersin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A and B. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2024

First Posted

April 17, 2024

Study Start

May 1, 2024

Primary Completion

July 7, 2024

Study Completion

July 7, 2024

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations