NCT07245043

Brief Summary

Peripheral venous catheterization, which involves the placement of an invasive device into the lumen of a peripheral vein, is a commonly used procedure in children receiving hospital treatment.IV insertion is a particularly painful and stressful experience for children. This is because children have more limited coping skills than adults. This study was designed as a randomized controlled trial to examine the effect of sticker intervention on pain and anxiety experienced during IV insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

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

Study Start

First participant enrolled

July 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 14, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

intravenous catheter applicationchildrenpain managementanxiety

Outcome Measures

Primary Outcomes (1)

  • 1. Outcome Measures

    The outcome measures for the sociodemographic data of the study will be collected using an "Information Form" containing questions about the child's age, gender, and descriptive characteristics such as whether they have previously had an intravenous catheter inserted.

    For children in both groups: Ten minutes before the intravenous procedure, during the procedure, and ten minutes after the procedure, both the child and the researcher will rate the child's anxiety and pain using scales.

Other Outcomes (2)

  • 2. Outcome Measures

    For children in both groups: Ten minutes before the intravenous procedure, during the procedure, and ten minutes after the procedure, both the child and the researcher will rate the child's pain using scales.

  • 3. Outcome Measures

    For children in both groups: Ten minutes before the intravenous procedure, during the procedure, and ten minutes after the procedure, both the child and the researcher will rate the child's anxiety using scales.

Study Arms (1)

Sticker Group

EXPERIMENTAL

The researcher will provide stickers that children in the sticker group can choose according to their own preferences during the application phase.Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers.

Behavioral: control group

Interventions

control groupBEHAVIORAL

Children in the control group will not undergo any procedures other than routine hospital procedures. Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers.

Sticker Group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5-10 years,
  • Children undergoing painful procedures
  • Children undergoing IV procedures

You may not qualify if:

  • Children who have undergone surgery,
  • Children who have undergone procedures other than intravenous interventions,
  • Children whose parents are not present,
  • Children with any chronic illness or additional complaints that may trigger pain from the procedure,
  • Children with mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Education and Research Hospital

Mardin, Artuklu, 47100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAgnosiaAnxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • HASRET YAĞMUR SEVİNÇ AKIN, Assistant Professor

    Harran University

    STUDY DIRECTOR
  • MAKSUDE YILDIRIM, Assistant Professor

    Adiyaman University

    STUDY CHAIR
  • BARIŞ AKIN, Specialist Nurse

    MARDIN EDUCATION AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Before implementing data collection tools, children and mothers will be informed, and data will be collected through face-to-face interviews using data collection forms after obtaining consent from those who agree to participate in the study. Children in the sticker group will be provided with stickers by the researcher during the application phase, which they can choose according to their own preferences.Children's anxiety and pain will be assessed based on both the researcher's and the child's reports before, during, and after the procedure, following consent from the mothers.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 24, 2025

Study Start

July 1, 2025

Primary Completion

September 24, 2025

Study Completion

October 24, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The data from the study will be published as a scientific article.

Locations