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Completed

NCT Number: NCT06841289

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

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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Key information

Conditions

Pain Management Agnosia Child Fear Anxiety Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu Üniversitesi

Ordu, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.).

Treatment and study plan

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.

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.

Primary outcomes

  1. Oucher Scale

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

    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.

  2. Child Anxiety Scale-Dispositional (CAS-D)

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

    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

  3. Child Fear Scale (CFS)

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

    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)

  4. Venham Pictorial Anxiety Scale (VRAQ)

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

    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

Secondary outcomes

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

    Time frame: 5 minute after the blood collection procedure.

    Nurse-Patient Cooperation Level and Parental Satisfaction Form was developed by Aydemir in 2020. "Nurse-Patient Cooperationsection consists of two questions directed to the nurse who performed the procedure. The scope of the questioning includes rating how the patient's compliance is during the application process and whether the continuity of the application is desired. The patient is asked to rate the patient's compliance with the procedure between zero and 10 points. Zero is the worst and 10 the best compliance. The status of wanting the application again was graded with the responses of I would like, I am undecided and I do not want. In the "Satisfaction of the Patient's Parent" section, there are two questions directed to the parents regarding the satisfaction and continuity of the application. Parental satisfaction was scaled on a five-point Likert scale one to five, with one being the most dissatisfied

Sponsors and collaborators

Lead sponsor

Dilek Kucuk Alemdar

Other

Registry information

Official study title

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

Acronym: PIPS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Jun 29, 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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