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

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

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-17

Study Completion Date

2025-06-15

Brief Summary

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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).

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Detailed Description

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Invasive procedures are the most common and important sources of pain, anxiety, stress and fear for children. Painful procedures also cause reluctance to medical procedures and distrust of nurses in both children and parents. Pain, anxiety and fear from needle procedures in childhood can persist into adulthood. It may cause negative emotional effects in the long term. Therefore, it is very important to reduce or eliminate pain during stressful and uncomfortable procedures in children. Nurses should also provide atraumatic care to children by minimizing pain. Eliminating pain and improving the quality of life of children should be one of the main goals of nursing care. The methods used in pain control in children are pharmacologic and nonpharmacologic methods. One of the non-pharmacologic methods, the technique of distraction, is the concentration of attention on a stimulus other than pain. Unlike what we have previously encountered in the literature, the Pediatric Invasive Pictorial Shield (PIPS) also aims to minimize the impact of the intervention by preventing the child from seeing the procedure being performed. Distraction cards are also known to be an effective method in children. 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

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Pain Management Fear Anxiety Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was a randomized controlled experimental, prospective study.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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

Study Groups

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Pediatric Invasive Pictorial Shield (PIPS)

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.

Group Type EXPERIMENTAL

Pediatric Invasive Pictorial Shield (PIPS)

Intervention Type 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.

Distraction cards

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.

Group Type OTHER

Distraction cards

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pediatric Invasive Pictorial Shield (PIPS)

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.

Intervention Type COMBINATION_PRODUCT

Distraction cards

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.).

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No