Clinical trial NCT06841289: The Effect of Pediatric Invasive Pictorial Shield (PIPS) and Distraction Card Use in Blood Collection Procedure
Official title: The Effect of Pediatric Invasive Pictorial Shield (PIPS) and Distraction Card Use on Pain, Fear and Anxiety in Blood Collection Procedure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Management
Fear Anxiety
Child
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 153
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a randomized controlled experimental, prospective study.
Primary purpose: SUPPORTIVE_CARE

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).

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).

Eligibility criteria: 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.).

Primary outcomes:
measure: Oucher Scale
timeFrame: 1 minute before, during procedure and 1 minute after the blood collection procedure.
measure: Child Anxiety Scale-Dispositional (CAS-D)
timeFrame: 1 minute before, during procedure and 1 minute after the blood collection procedure.
measure: Child Fear Scale (CFS)
timeFrame: 1 minute before, during procedure and 1 minute after the blood collection procedure.
measure: Venham Pictorial Anxiety Scale (VRAQ)
timeFrame: 1 minute before, during procedure and 1 minute after the blood collection procedure.
Secondary outcomes:
measure: Nurse-Patient Collaboration and Parental Satisfaction Form (NPPC-EMF)
timeFrame: 5 minute after the blood collection procedure.
Other outcomes:
Locations:
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Dilek Küçük Alemdar, Professor
role: STUDY_DIRECTOR
References: