The Effect of Sticker Intervention on Pain and Anxiety

The Effect of Sticker Intervention on Pain and Anxiety Experienced During IV Intervention

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Pain Management; INTRAVENOUS CATHETER APPLICATION
• Intervention / Treatment: Behavioral: control group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Artuklu
    • Mardin, Artuklu, Turkey (Türkiye), 47100
      • Mardin Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2. Outcome Measures	Visual Pain Scale: The scale is a 10 cm line scaled from 1 to 10 to determine the severity of pain in children, with 10 representing maximum pain and 0 representing no pain. Patients are asked to mark a spot on the scale according to the pain they feel.	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	Child Anxiety Scale-State (CAS-D): The scale is designed in the shape of a thermometer. Each horizontal line on the thermometer represents one point, and the light bulb at the bottom represents 0 points. As you move upward, the score increases, with a maximum of 10 points. A score of 0 on the scale indicates no anxiety, while a score of 10 indicates the highest level of anxiety.	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.

Collaborators and Investigators

• Sponsor: Harran University
• Investigators: Study Director: HASRET YAĞMUR SEVİNÇ AKIN, Assistant Professor, Harran University; Study Chair: MAKSUDE YILDIRIM, Assistant Professor, Adiyaman University; Principal Investigator: BARIŞ AKIN, Specialist Nurse, Mardin Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): September 24, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: children; anxiety; pain management; intravenous catheter application
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Agnosia; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: HRU/25.12.67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data from the study will be published as a scientific article.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No