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

Dilek Kucuk Alemdar

Status: Not yet enrolling

Conditions: Child; Pain Management; Fear Anxiety

Treatments: Combination Product: Pediatric Invasive Pictorial Shield (PIPS); Behavioral: Distraction cards

Study type: Interventional

Funder types: Other

Identifiers

NCT06841289

KAEK360

Details and patient eligibility

About

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).

Full 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).

Enrollment: 153 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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153 participants in 3 patient groups

Pediatric Invasive Pictorial Shield (PIPS)

Experimental group

Description:

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.

Treatment:

Combination Product: Pediatric Invasive Pictorial Shield (PIPS)

Distraction cards

Other group

Description:

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.

Treatment:

Behavioral: Distraction cards

Control

No Intervention group

Description:

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.