ShotBloker and Helfer Skin Tap Technique During Intramuscular Injection in Children

Study Overview
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Brief Summary
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To examine the effect of the Helfer skin tap technique and ShotBloker application on pain and fear experienced during intramuscular injection in children aged 6-12 in the pediatric emergency unit. It was planned as a randomized controlled experimental study to determine its effect on fear. The population of the study will be children aged 6-12 years who applied to the Tarsus State Hospital, and Pediatric Emergency Clinic and the sample will be 177 children who will undergo intramuscular intervention and meet the criteria for inclusion in the study. In data collection; Data collection form, Wong-Baker Scale, and Child fear scale will be used. In order to examine the mean scores of pain and fear according to intramuscular administration techniques in children, appropriate tests will be used by making an analysis of conformity to normal distribution.

Detailed Description
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Pain is an experience of complex perceptions that overwhelms the patient, distorts their behavior and thoughts, prompts them to perform activities that require immediate attention and aim to stop the pain, and causes behavioral reactions and automatic changes. To examine the effect of the Helfer skin tap technique and ShotBloker application on pain and fear experienced during intramuscular injection in children aged 6-12 in the pediatric emergency unit. Type of Study: It was planned as a randomized controlled experimental study to determine the effect of Helfer skin tap technique and Shot Blocker application on pain and fear experienced during intramuscular injection in children aged 6-12 years who applied to the pediatric emergency clinic. Research Population and Sample Selection The population of the study will be children aged 6-12 years who applied to the Tarsus State Hospital, Pediatric Emergency Clinic, and the sample will be 177 children who will undergo intramuscular intervention, meeting the criteria for inclusion in the research. According to the results of the G-power analysis for the sample size, in accordance with the literature of Canbulat and Bal (2015), Canbulat et al (2014) and Mutlu (2012) to find a medium power effect size difference of 0.25 between the groups, type I error 0.05, power of the test. While 0.80 (α= 0.05, β= 0.20), the minimal sample size was 177 (n=59 for each group). Data collection Stages of Research Stage 1: A pilot study will be conducted with 20 children in order to evaluate the appropriateness of the forms and scales used before the research. Stage 2: The purpose of the research and how to record the data will be explained to the nurse who will administer the intramuscular injection procedure using the ventrogluoteal region and to the nurse who will observe the child's pain and fear during the procedure. The children in the sample group and their parents will be informed about the path followed in practice and the research, and their verbal and written consent will be obtained. Stage 3: The patients who meet the sample selection criteria will be randomly and equally distributed into 3 groups through a program in the computer environment, and randomization will be provided. (http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html) (1st experimental group Helfer skin tap technique suitable group, 2nd experimental group Shot Blocker group, 3rd group control group) Children in each group will be provided with their parents. Stage 4: The nurse observing the children in all groups before the procedure will fill in the demographic data form, measure the child's pulse, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent. Stage 5: Intramuscular injection will be given to the ventrogluoteal region by following the procedure steps for the children in all groups. The intramuscular injection procedure will be performed by the same nurse. During the procedure, the child's pain and fear will be observed by the observing nurse and recorded in the observation form. At this stage; First Experimental group; During the intramuscular injection to be applied to the ventrogluoteal region, the level of pain and fear will be examined using the Helfer skin tap technique. Second Experiment group; During the intramuscular injection to be applied to the ventrogluoteal region, the level of pain and fear will be examined by using Shot Blocker. To the control group; The level of pain and fear will be examined during intramuscular injection into the ventrogluotealregion without any intervention. Stage 6: 5 minutes after the procedure, the pain and fear level of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse. Stage 7: The analysis and reporting of the obtained data will be done.

Official Title
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The Effect of ShotBloker and Helfer Skin Tap Technique on Pain and Fear During Intramuscular Injection in Children Aged 6-12 in the Pediatric Emergency Unit

Conditions
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Pain, Acute, Fear, Emergencies, Child, Only, Injection Fear

Intervention / Treatment
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* Other: Helfer skin tap technique
* Device: Shot Blocker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be 6-12 years old, Volunteering to participate in the research, Not having a chronic disease, not having a mental or neurological disability, Being able to communicate verbally, Not taking any medication that has an analgesic effect at least 6 hours before applying to the emergency room. Not have a life-threatening (sepsis, shock, respiratory/cardiogenic arrest, etc.) disease Exclusion Criteria: Not to be between the ages of 6-12, Not volunteering to participate in the research, Having a chronic disease, mental or neurological disability, Taking any analgesic medication at least 6 hours before applying to the emergency room Having a life-threatening (sepsis, shock, respiratory/cardiogenic arrest, etc.) disease

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helfer Skin Tap<br>Helfer Skin Tap (rhythmic tapping of the skin at the injection site to relax the muscles during injection) is an effective method in reducing pain in intramuscular applications in studies performed with the injection technique. Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent. During the intramuscular injection to be applied to the ventrogluteal region, the level of pain and fear will be examined using the Helfer skin tap technique. 5 minutes after the injection, the pain and fear level of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse. | Other: Helfer skin tap technique<br>* Using the Helfer skin tap technique during intramuscular injection to the ventrogluteal region.<br>|
| Experimental: Shotblocker<br>Shotblocker is a flat, horseshoe-shaped device with short, non-sharp 2 mm thick blunt protrusions that connect with the skin, and a hole in the middle to expose the injection site used to reduce pain during subcutaneous or intramuscular injection applications. Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent. During the intramuscular injection to be applied to the ventrogluteal region, the level of pain and fear will be examined by using Shot Blocker. 5 minutes after the injection, the pain and fear levels of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse. | Device: Shot Blocker<br>* Shot Blocker will be used during intramuscular injection to be applied to the ventrogluteal region.<br>|
| No Intervention: control group<br>Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent. The level of pain and fear will be examined during intramuscular injection into the ventrogluteal region without any intervention. 5 minutes after the injection, the pain and fear level of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker Scale score | Wong-Baker Scale (Pain Face Rating Scale): In the Wong-Baker scale, there are faces representing increasing pain severity from left to right, ranging from zero to five. The leftmost face has a smiling expression, indicating a pain-free state, while the right-most face has a crying expression, corresponding to the most severe pain. Below each facial expression is a short description describing the severity of pain: 0 - no pain, 1- a little pain, 2- a little more pain, 3- even more pain, 4- a lot of pain, 5- the most severe pain. Before, during, and 5 minutes after the injection, the pain level of the children in all groups will be re-evaluated. | 1 day | 
| Child Fear Scale score | Child Fear Scale: The Child Fear Scale is a scale used to assess the anxiety level of children with 5 face shapes scored between 0-4. 0 = no anxiety, 4 = severe anxiety. Before, during, and 5 minutes after the injection, the fear level of the children in all groups will be re-evaluated. | 1 day | 
| mean arterial pressure | The mean arterial pressureof the child was evaluated and recorded before during, and 5 minutes after the injection | 1 day | 
| heart rate | The heart rate of the child was evaluated and recorded before during, and 5 minutes after the injection | 1 day | 
| saturation | The saturation of the child was evaluated and recorded before during, and 5 minutes after the injection | 1 day |