The Effect of Pediatric Invasive Pictorial Shield (PIPS) and Distraction Card Use in Blood Collection Procedure

NCT06841289 | Completed

• 1 other identifier: KAEK360
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned as a randomized controlled experimental study to minimize the pain, anxiety and fear of the child during venous blood sampling in order to avoid a painful experience in the future. The research will be conducted in the Pediatric Blood Collection Unit of Giresun Gynecology and Obstetrics Training and Research Hospital in children aged 6-10 years. The research data will be collected using the "Information Form on Descriptive Characteristics of the Child and Blood Collection Procedure, Child Anxiety Scale-Disposition (CAS-D), Oucher Scale, Child Fear Scale (CFS), Venham Pictorial Anxiety Scale (VRAAS)" and Nurse-Patient Cooperation and Parent Satisfaction Form (NPPS-EMF).

Conditions

Pain Management; Fear Anxiety; Child

Outcome Measures

Primary Outcomes (4)

• Oucher Scale

  Oucher is a poster-like tool designed to help children self-report the intensity of their pain. The Oucher consists of two scales: a numerical scale from 0-10 for older children and a photographic scale with six pictures for younger children. The Oucher can be used to assess pain intensity whenever the child is awake and conscious. Oucher can be used in children aged 3-12 years.

  1 minute before, during procedure and 1 minute after the blood collection procedure.

• Child Anxiety Scale-Dispositional (CAS-D)

  The CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. In this scale for children aged four to ten, children instructed to "Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer". "If you are a little worried or nervous, the emotions might go up a little on the thermometer. If you are very, very anxious or nervous, emotions all the way to the top. Put a line on the thermometer showing how anxious or nervous you are". To measure state anxiety (CAS-D), the child is asked to mark how they feel "right now". The score can vary between 0 and 10

  1 minute before, during procedure and 1 minute after the blood collection procedure.

• Child Fear Scale (CFS)

  This scale is used to determine the child's level of fear. The child fear scale is a visual scale consisting of five facial expressions characterized as no reaction (0=no anxiety) and scared face (4=severe anxiety) and can be scored from 0 to 4. It is intended for children aged 5-10 years (Gerçeker et al., 2018)

  1 minute before, during procedure and 1 minute after the blood collection procedure.

• Venham Pictorial Anxiety Scale (VRAQ)

  It was developed as a situational anxiety scale for children. It measures anxiety appropriate for children in stressful situations. The scale was developed by Venham et al. in 1979. The scale is used for children over 3 years of age. The scale consists of eight sections and each section two pictures. The pictures in each section are shown to the child in order. The picture with anxiety is given 1 point and the picture without anxiety is 0 point. The lowest score is 0 and the highest score is 8 points. In the scoring system from 0 to 8, as the number of points increases, the rate of anxiety increases

  1 minute before, during procedure and 1 minute after the blood collection procedure.

Secondary Outcomes (1)

• Nurse-Patient Collaboration and Parental Satisfaction Form (NPPC-EMF)

  5 minute after the blood collection procedure.

Study Arms (3)

Pediatric Invasive Pictorial Shield (PIPS)

EXPERIMENTAL

It is a device used to distract children during clinical procedures (blood sampling, invasive procedures, etc.) by making them feel less pain, stress and fear. It is an 18x15 cm 3D printed device designed to be worn around the upper arm, above the elbow, and used to hide the procedure from view and attract the child's attention with stickers printed on one side.

Combination Product: Pediatric Invasive Pictorial Shield (PIPS)

Distraction cards

OTHER

Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns can only seen by the child if he/she looks carefully. During the procedure, the child is expected to focus on the cards and answerabout the pictures and shapes on the cards. In this study, 5X8 cm cards with various pictures and shapes will be used . For the children in this group, the pain, fear will be scored 1 minute before, during and 1 minute after the blood collection procedure.

Behavioral: Distraction cards

Control

NO INTERVENTION

No distraction method will be applied to the children in the control group before the blood collection procedure. After explaining the procedure according to the developmental level of the child, blood collection will be performed by the same nurse in accordance with the institutional policy.

Interventions

Pediatric Invasive Pictorial Shield (PIPS) COMBINATION_PRODUCT

It is a device used to distract children during clinical procedures (blood sampling, invasive procedures, etc.) by making them feel less pain, stress and fear. It is an 18x15 cm 3D printed device designed to be worn around the upper arm, above the elbow, and used to hide the procedure from view and attract the child's attention with stickers printed on one side. The device is fixed on the child's arm by means of a tourniquet that can be interchangeably attached. The child asked questions about the pictures related to the stickers to distract his/her attention from the procedure. While answering these questions, the child will not see the procedures and will pay attention to the pictures, while the procedural procedure (such as blood sampling, intravenous intervention) will be performed. For the children in this group, the pain, fear will be scored 1 minute before, during and 1 minute after the blood collection procedure.

Pediatric Invasive Pictorial Shield (PIPS)

Distraction cards BEHAVIORAL

Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns can only seen by the child if he/she looks carefully. During the procedure, the child is expected to focus on the cards and answerabout the pictures and shapes on the cards. In this study, 5X8 cm cards with various pictures and shapes will be used.

Distraction cards

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child must be between 6-10 years old, and the child and parents must agree to participate in the study
• Blood collection is done by the same nurse
• Standard information is given to the child and family before blood collection - - The blood collection method to be used for the procedure (butterfly set
• Children should have the perception level to evaluate the pain/fear/anxiety scale (successfully complete the scale tests)
• The child does not have any auditory, mental or neurological disability that may affect the child's participation in the research
• The child has no hearing, speech or visual impairment Blood collection from the antecubital region
• Single attempt intervention.

You may not qualify if:

• The child has any special needs (physical, sensory or mental)
• The child is admitted to the hospital with a complaint of acute pain
• Body temperature outside the range of 36.5-37.2°C153
• Having a disease that can cause chronic pain The child has taken analgesics in the last 6 hours
• The child has a health problem that may affect the level of pain (tissue trauma, burn, fracture, etc.).

Sponsors & Collaborators

• Dilek Kucuk Alemdar: lead

Study Sites (1)

Ordu Üniversitesi

Ordu, Ordu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Küçük Alemdar, Professor

  Ordu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: After the children who met the inclusion criteria were assigned to the study groups by stratified block randomization, their written informed consent will be obtained through the informed consent form without informing their parents which group they are included in. Since the researcher will administer the PIPS and distraction cards to the children, blinding will not be possible. However, in order to prevent detection bias, the output measurements of the study will be made by the nurse working in the blood collection unit where the study will be conducted, who does not know who is in the experimental group and who is in the control group. In order to prevent bias in the evaluation of the data, the study groups will be coded in the database as A, B and C by someone other than the researcher, and the data be analyzed by a statistical expert independent of the research. It was aimed to prevent statistical and reporting bias by blinding in terms of output measurements, statistical analysis
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The study was a randomized controlled experimental, prospective study.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: February 17, 2025
• Primary Completion: April 15, 2025
• Study Completion: June 15, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)