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NCT Number: NCT07245043

The Effect of Sticker Intervention on Pain and Anxiety

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.

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Key information

Conditions

INTRAVENOUS CATHETER APPLICATION Agnosia Anxiety Anxiety Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mardin Education and Research Hospital

Mardin, Artuklu, 47100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

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.

Primary outcomes

  1. 1. Outcome Measures

    Time frame: 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.

    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.

Other outcomes

  1. 2. Outcome Measures

    Time frame: 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.

    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.

  2. 3. Outcome Measures

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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