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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Child Fear Scale score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Helfer Skin Tap
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.
干预措施: Helfer skin tap technique (Other)
Shotblocker
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.
干预措施: Shot Blocker (Device)
control group
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.
结局指标
主要结局
Child Fear Scale score
时间窗: 1 day
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.
heart rate
时间窗: 1 day
The heart rate of the child was evaluated and recorded before during, and 5 minutes after the injection
mean arterial pressure
时间窗: 1 day
The mean arterial pressureof the child was evaluated and recorded before during, and 5 minutes after the injection
saturation
时间窗: 1 day
The saturation of the child was evaluated and recorded before during, and 5 minutes after the injection
Wong-Baker Scale score
时间窗: 1 day
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.
次要结局
未报告次要终点
研究者
Atiye Karakul
Principal Investigator
Tarsus University