The Effect of Sticker Intervention on Pain and Anxiety

NCT ID: NCT07245043

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-10-24

Brief Summary

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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.

Detailed Description

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The study consists of an sticker group and a control group. Participants will be assigned to groups using stratified randomization. Anxiety levels in both groups will be assessed using the Children's Anxiety Scale-State (ÇAS-D), while pain levels will be evaluated by both the child and the researcher using a visual pain scale before, during, and after the procedure.For children in both groups, 10 minutes before the intravenous procedure, both the child and the researcher will rate the child's anxiety and pain using scales.During the IV procedure, the researcher will place the sticker chosen by the child on the IV insertion site. Meanwhile, the researcher will rate the child's anxiety and pain using scales. No sticker will be placed on the IV insertion site of the control group, and the child's anxiety and pain will be rated using scales.For both groups, 10 minutes after the intravenous procedure, both the child and the researcher will rate the child's anxiety and pain using scales.

Conditions

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INTRAVENOUS CATHETER APPLICATION Pain Pain Management Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sticker Group

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.

Group Type EXPERIMENTAL

control group

Intervention Type BEHAVIORAL

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.

Interventions

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control group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harran University

OTHER

Sponsor Role lead

Responsible Party

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HASRET YAĞMUR SEVİNÇ AKIN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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HASRET YAĞMUR SEVİNÇ AKIN, Assistant Professor

Role: STUDY_DIRECTOR

Harran University

MAKSUDE YILDIRIM, Assistant Professor

Role: STUDY_CHAIR

Adiyaman University

BARIŞ AKIN, Specialist Nurse

Role: PRINCIPAL_INVESTIGATOR

MARDIN EDUCATION AND RESEARCH HOSPITAL

Locations

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Mardin Education and Research Hospital

Mardin, Artuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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HRU/25.12.67

Identifier Type: -

Identifier Source: org_study_id

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