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临床试验/NCT06312228
NCT06312228已完成不适用

The Effect of the Helper Skin Tap Technique and Buzzy® Application on the Level of Pain and Anxiety Experienced by Children During Vaccination

Tarsus University2 个研究点 分布在 2 个国家目标入组 96 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
2
主要终点
Child Information Form

研究概览

简要总结

Aim: This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023. Data Collection Form, Wong-Baker pain scale, Fear scale and Buzzy® device were used as data collection tools. Buzzy® and Helfer skin tap technique were applied to the children in the intervention group before and after the vaccine injection, while routine vaccine injection was applied to the children in the control group. Children's pain and fear responses were evaluated by the nurse and parents before and after vaccine injection, and physiological parameters were evaluated by the nurse before and after vaccine injection.

详细描述

This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.

Materials and Methods Setting The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023.

Sample The population of the study, which was planned as a randomised controlled experimental study, consisted of 4-year-old children who applied to Bakırköy Family Health Centre (FHC) No. 9 for MMR vaccination. According to the power analysis for the sample size in line with the literature (Mahato and Thakur 2019; Şıktaş and Uysal 2023), the power of the sample was calculated with the G*Power 3.1 programme. With a Type I error of 0.05 and a test power of 0.80 (α= 0.05, 1-β= 0.80), the minimum sample size (30 children in each group) was calculated as 90 children. Considering the losses that may occur from the sample for any reason during the study period, the study was completed with 96 children, including 32 children in the study and control groups.

Data Collection In the study, children who came to the Family Health Centre for MMR vaccination were first evaluated in terms of sampling criteria, and infants who did not meet the criteria were excluded from the study. The nurses who collected and administered the data are different. According to the childhood vaccination calendar of the Ministry of Health, MMR, quadrivalent mixed vaccine (DaBT-IPA (diphtheria, acellular pertussis, tetanus, inactive polio) are administered at the age of 4 years. The infants included in the study were first given MMR vaccine in the left arm and the other vaccine was given in the leg 10 minutes after the end of the administration.

Application MMR vaccine was administered according to the vaccine administration technique in the Ministry of Health's Expanded Immunisation Programme (2009) Circular. Vaccines are stored in the refrigerator under cold chain conditions between +2 0C - +8 0C. Before vaccine injection, it was ensured that the vaccination room was well lit and warm, and children were in a comfortable environment. The children in the Helfer Skin Tap Technique, buzzy and control group, who met the sampling criteria, were first examined by the family physician, and the parents of the children who did not have any objection to vaccination were informed about the research and their verbal and written consent was obtained and then the data collection form was filled out. Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. The child was first seated on the parent's lap (on the knee) and the holding position was adjusted. The child's legs were placed between the parent's legs and the arms were wrapped around the parent to hold the child. After the vaccine injection, pain and fear responses were evaluated by the nurse and parent using the Wong-Baker pain scale and fear scale. In addition, physiological parameters of the children were also measured and recorded.

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
4 Years 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The child being at least 4 years old,
  • The administration of the DTP vaccine,
  • Being at an appropriate weight for their age,
  • The child not having received any analgesic medication during the day,
  • The willingness of the parent to participate in the research

排除标准

  • - Having a neurological illness,
  • Having a chronic illness,
  • Having an allergy (egg allergy),
  • Having a body temperature above 37.5 degrees Celsius

研究组 & 干预措施

Helper Skin Tap Technique Group

Experimental

Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. Slow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn.

干预措施: Helfer Skin Tap (Other)

Buzzy Group

Experimental

Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. The ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds.

干预措施: Buzzy (Other)

Control Group

No Intervention

Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. MMR vaccine injection was routinely administered in the area corresponding to the left deltoid muscle without any intervention or application to the injection site.

结局指标

主要结局

Child Information Form

时间窗: 1 day

The information form has been prepared by reviewing the literature on the subject (Canbulat and Bal 2015; Canbulat et al 2014) and includes the child's age, gender, height, weight, presence of other children in the family, physiological parameters before and after vaccination injection, Wong-Baker pain score, and Fear score evaluated by the nurse, parent, and child before and after the vaccination injection. There are a total of 5 questions in the data collection form.

Child Fear Scale

时间窗: 1 day

The Child Fear Scale is used to assess the anxiety levels of children with five face shapes scored between 0-4: 0 = no anxiety, and 4 = severe anxiety. The scale can be evaluated by both the child and the researcher before, during, and after the intervention.

Wong-Baker Scale (Pain Facial Expression Scale)

时间窗: 1 day

The Wong-Baker scale consists of faces representing increasing levels of pain from zero to five, moving from left to right. The face on the far left has a smiling expression, indicating a pain-free condition, while the face on the far right has a crying expression, representing the most severe pain. Each facial expression is accompanied by a brief description explaining the pain intensity: 0 - no pain, 1 - mild pain, 2 - a bit more pain, 3 - even more pain, 4 - quite a lot of pain, 5 - the most severe pain.

次要结局

未报告次要终点

研究者

发起方
Tarsus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duygu Sonmez Duzkaya

Principal Investigator

Tarsus University

研究点 (2)

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