Comparison of Two Different Skin Stimulation Techniques on Intramuscular Injection Pain and Emotional Responses in Children: Helfer Skin Tap Technique and ShotBlocker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Children's Emotional Indicator Scale
研究概览
简要总结
Study Aim: This study aims to determine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional indicators, and physiological parameters during intramuscular (IM) drug administration in children aged 7-12 years.
Study Design This research is designed as a randomized controlled experimental study.
Study Setting and Characteristics The study will be conducted at the Pediatric Emergency Clinic of Fırat University Hospital. The Pediatric Emergency Clinic consists of two observation rooms with a total of 12 beds, where children's medication administration and follow-ups are carried out.
The study population comprises children aged 7-12 years who received Vastus Lateralis IM drug administration (ZOFER® 8mg/4ml Injectable Solution - Ondansetron Hydrochloride Dihydrate) at the Pediatric Emergency Clinic of Fırat University Hospital and met the inclusion criteria during the specified study period.
For sample size estimation, the pain scores from the study by Sivri, Bilgen, and Balcı (2019) were considered. Based on their findings (d = 0.82; α = 0.05), it was determined that a sample size of 40 children per group (HST, ShotBlocker, and control) would be sufficient. Considering potential dropouts, the sample size was increased by 10%, and the study was planned to include a total of 132 children who met the inclusion criteria and provided informed consent along with their parents.
详细描述
This randomized controlled experimental study aimed to examine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional responses, and physiological parameters in children aged 7-12 years undergoing intramuscular (IM) drug administration. The study was conducted at the Pediatric Emergency Clinic of Fırat University Hospital between October 1, 2024, and January 31, 2025. The clinic consisted of two observation rooms with 12 beds, where children's medication administration and follow-ups were carried out. The study population included children aged 7-12 years who received Vastus Lateralis IM drug administration (ZOFER® 8mg/4ml Injectable Solution - Ondansetron Hydrochloride Dihydrate) and met the inclusion criteria.
The sample size was determined based on the pain scores from the study by Sivri, Bilgen, and Balcı (2019), with an effect size of d = 0.82 and α = 0.05, indicating that a sample of 40 children per group (HST, ShotBlocker, and control) was sufficient. To account for potential dropouts, the sample size was increased by 10%, resulting in a total of 132 children who met the inclusion criteria and provided informed consent along with their parents.
Participants' pre-test data were collected by the researcher before randomization. To ensure homogeneity, children were stratified based on age, gender, quality of life, and fatigue levels before being assigned to groups using a simple random sampling method. Blinding among researchers was not feasible, and patients in different groups were assigned to different hospital beds. To minimize selection bias, simple randomization was applied. The study protocol was registered in the ClinicalTrials.gov database, supported by the U.S. National Library of Medicine and the National Institutes of Health (NIH). Patients were unaware of their assigned groups (experimental or control).
Data Collection and Measurement Tools
Data were collected using the following tools:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 7 to 12 years old,
- •BMI level in the appropriate range according to age,
- •IM drug administered to the Vastus Lateralis muscle,
- •No disease that causes chronic pain,
- •Not taking any analgesic medication in the last 8 hours before the procedure,
- •No mental or neurological disability,
- •No visual or auditory problems preventing the application of the scales,
- •Speaks and understands Turkish,
- •Children whose parents and themselves agreed to participate in the study were included in the study.
排除标准
- •- BMI level is not in the appropriate range according to age,
- •Forms with incomplete or incorrect answers,
- •Children who did not volunteer to participate in the study were excluded from the study.
研究组 & 干预措施
Helfer Skin Tap Group
Helfer Skin Tap Group: The patient will be positioned in the most comfortable way possible. For the injection in the Vastus Lateralis muscle, the patient will be positioned appropriately lying down. After identifying the injection site, the skin will be gently tapped with the palmar surface of the dominant hand's fingers for approximately 5 seconds (about 15 strokes) to relax the muscles. After cleaning the skin with alcohol, the cap of the syringe in the dominant hand will be removed. The non-dominant hand's thumb and index finger will form a large V, and gentle taps will be applied to the skin again. The entire palm of the hand will be used to deliver three firm strokes to the muscle. The strokes (not slaps) should be firm to stimulate the large muscle fibers. After counting to three, the syringe will be inserted into the muscle at a 90° angle simultaneously.
干预措施: Helfer skin tap technique (Other)
Shotblocker Group
- Ensure that the patient takes the most comfortable position possible. For injection into the Vastus Lateralis muscle, the patient will be made to lie in the appropriate position.
- While removing the cap of the injector needle and holding it between the index and thumb of the active hand, the Shotblocker will be placed appropriately on the injection site with the passive hand, light pressure will be applied.
- The syringe will be inserted into the tissue smoothly at an angle of 90°. The needle will be prevented from moving in the tissue by holding the ajutage with the thumb and index finger of the passive hand. While holding the Shotblocker with the passive hand, the needle will be prevented from moving in the tissue by holding the ajutage with the thumb and index finger of the passive hand. Aspiration will be performed by pulling the piston back with the active hand.
- The drug will be injected into the muscle at a rate of 1ml/10sec.
干预措施: Shotblocker technique (Other)
control
Children included in the control group will be administered IM Zofer drug (the drug will be injected into the muscle at a rate of 1ml/10 sec) with routine standard care of the ward.
结局指标
主要结局
Children's Emotional Indicator Scale
时间窗: 1 month
The Children's Emotional Indicator Scale (CEIS) was developed by Li and Lopez (2005) to provide a simple, objective and consistent method for nurses to identify children's emotional behaviors during stressful medical procedures. The CSA consists of five categories of observable emotional behaviors (Facial expression, Vocalization, Activity, Interaction and Level of cooperation). Each category has a value between 1-5. The total score that can be obtained from the scale varies between 5-25. The higher the scores obtained from the scale, the higher the negative emotional indicators.
次要结局
未报告次要终点
研究者
seher ÇEVİK
Assistant Professor
Inonu University