Clinical Trials Directory

Trials / Completed

CompletedNCT06841289

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

The Effect of Pediatric Invasive Pictorial Shield (PIPS) and Distraction Card Use on Pain, Fear and Anxiety in Blood Collection Procedure

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
153 (actual)
Sponsor
Dilek Kucuk Alemdar · Academic / Other
Sex
All
Age
6 Years – 10 Years
Healthy volunteers
Not accepted

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).

Detailed description

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

Interventions

TypeNameDescription
COMBINATION_PRODUCTPediatric 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.
BEHAVIORALDistraction cardsDistraction 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.

Timeline

Start date
2025-02-17
Primary completion
2025-04-15
Completion
2025-06-15
First posted
2025-02-24
Last updated
2025-06-29

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06841289. Inclusion in this directory is not an endorsement.