Clinical trial NCT04772430: "The Effect of Snow Globe Used in Infancy Vaccination Applications on Pain Level."
Official title: Zonguldak Bulent Ecevit University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: pain
immunization
diverting attention
infancy
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this research is to determine the effect of the snow globe, which is used as a method of diverting attention, to the perception of pain that develops during the application of vaccines in infants between 2-6 months of age.

Detailed description: Atraumatic care philosophy developed by Donna Wong; it is a principle of therapeutic care aimed at minimizing or eliminating the physical and psychological problems experienced by the child and his/her family. Pediatric nurse; it is obliged to offer atraumatic care by ensuring the cooperation of the child and his/her family, reducing pain and controlling stressors.

In accordance with the principles of atraumatic care; limitation of painful initiatives to prevent or reduce physical stress sources, regulation of environmental conditions, use of pharmacological and nonpharmamological pain removal methods in the presence of pain; promoting family-centered care in order to ensure the unity of children and family members; informing the child and his family about care to ensure the development of a sense of control, resting recommendations on care, establishing a daily care program.

The American Pain Association considers pain the fifth life finding. Studies show that all babies, including preterm babies, suffer pain and can distinguish pain from other sensory experiences. Controlling pain in children is multidisciplinary team work. It makes the nurse different from other team members in the control of pain and ensures that she is in an indispensable position; the nurse spends a long time with children, learns about the child's previous pain experiences and methods of coping with pain and benefits from coping methods when necessary, teaching the child and his family strategies to cope with pain, guiding them, applying planned treatment, monitoring their effects, results and empathizing, in short, being able to practice the nursing process.

Children who are often subjected to painful invasive interventions from the newborn period; however, they have a structure that requires the consideration of their level of development, cognitive and communicative skills, previous experiences of pain. According to the American Academy of Pediatrics , newborns and children are exposed to a total of 24 injections due to vaccination in the first 2 years of their life. In Turkey, the total number of injections for routine vaccination of children up to 2 years of age is 18. The negative effects of pain, which cannot be managed effectively, in physiological and psychological dimensions can occur even years later. The pain and stress experienced with deterioration in the clinical condition of newborns brings many complications.

Pain in children is more difficult to assess than in adults. The perception of pain in children, age, gender, family reactions to pain, previous experiences, insomnia, fatigue, fear, sadness, anger, being in an unpleasant environment can affect.

Conditions caused by pain include short-term changes such as respiratory irregularity, hypoxemia, fading or redness, blood pressure changes, increased heart rate and oxygen consumption, enlargement of pupils, as well as permanent, structural and functional (endocrine, behavior and immune system) changes. It negatively affects the behavior, family infant interaction, diet and clinical course of babies who warn of long-term and frequent pain, as well as prevents the baby's adaptation to the outside world. Repeated painful interventions can lead to neurotoxia and lead to deterioration in social cohesion, anxiety, change in pain sensitivity, stress disorders, hyperactivity/attention deprivation in the future. That's why the American Pain Society (APS) and the American Academy Of Pediatrics (AAP) recommend minimizing pain and anxiety due to procedures. The high number of vaccines for children and infants and the psychological traumas caused by the pain caused by the vaccines make it mandatory to intervene in the pain that occurs during vaccination and are one of the ethical issues

Research shows that nurses do not make adequate pain assessments and do not use nonpharmamological methods effectively. Nonpharmaciological pain methods, which are effective in consequential or alone, can also be used in the elimination of pain, among the non-pharmacological methods such as hot cold application, diverting attention, listening to music, balloon blowing, reading books, watching movies, vibration, transcutaneous electrical nerve stimulation (transcutaneous electrical nerve stimulation) application.

Divert attention; it is a non-drug method that is often used in the management of pain in children. It removes the perception of pain by focusing the individual's attention away from pain and in another focus. More work is needed to improve pain management in children and illuminate optimal pain management and strategies that take into account children-specific needs

Eligibility criteria: Inclusion Criteria:

* Being registered at Bartın Family Health Center
* Being in the age range of 2-6 months
* Having parental consent
* Does not have a congenital or chronic health problem,
* Not taking an analgesic drug in the last 4 hours,
* Infants of families who have accepted to participate in the study and signed the informed consent form will be included in the study

Exclusion Criteria:

* Being aged between 0-1 months and over 6 months,
* No parental consent,
* Using analgesics in the last 4 hours,
* The child has a congenital or chronic health problem

Primary outcomes:
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale
timeFrame: 2-6 months
Secondary outcomes:
measure: Heart rate
timeFrame: 2-6 months
measure: oxygen saturation
timeFrame: 2-6 months
measure: crying duration of babies
timeFrame: 2-6 months
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Betül Akkoç
state: Bartın
Study officials:
References: