The Effect on Pain and Satisfaction of Two Different Non-Pharmacological Methods Used During Coronavirus (Covid-19) Vaccination
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Primary Outcome Measure-1
研究概览
简要总结
The aim of this study was to determine the effect on pain and satisfaction during the administration of Covid-19 vaccination of two different non-pharmacological methods: squeezing a stress ball and placing Buzzy® on the injection site.
The research was planned with a prospective, randomized controlled and experimental design. Data collection will take place at the Covid-19 Vaccination Clinic of the Health Research and Application Center of Bursa Uludağ University. The research sample will consist of individuals who on the date of the beginning of the data collection stage asked for or approved the Pfizer-BioNTech vaccination for themselves from the Turkish Ministry of Health, and who agreed to participate in the research.
The size of the study sample was statistically determined with the program G*Power 3.1.7. As a result of power analysis, the total minimum sample width was calculated as 120 people, with 40 in each group, accepting type I error level as 5% and in order to achieve an 80% power level. Individuals who meet the research criteria will be assigned to the implementation and control groups by means of a randomization list created by computer according to age and gender.
Research data will be collected face to face, using an Individual Description Form, a Visual Comparison Scale and a Visual Individual Satisfaction Scale.
The following interventions will be performed on the individuals in the intervention group in addition to the standard vaccination procedure:
Covid-19 vaccination procedure with individuals in the stress ball group: With this group, a yellow stress ball will be used which is 6cm in diameter, of medium hardness and made of high quality silicone, and which returns to its original shape after being squeezed. The researcher will explain to the individuals in the group how they should use the stress ball five minutes before beginning the vaccination and during the procedure. The individuals will be taught to take the stress ball in their right hand, the side on which the vaccination will not be given, and, counting from one to three, to squeeze and release the ball, continuing until the procedure is finished. It will be explained that during the procedure, they should give their attention to the stress ball and focus on squeezing it.
Covid-19 vaccination procedure with individuals in the Buzzy® group: Individuals in this group will use the Buzzy® device. Before the vaccination procedure, the researcher will place the Buzzy® device, which will be at room temperature, on the vaccination site, and it will vibrate in a non-discomforting way for one minute. After this, the Buzzy® device will be removed from the site, and the nurse will perform the vaccination. Because Buzzy® is a device which can be re-used, it will be disinfected after each vaccination procedure, and re-used with other individuals. The Buzzy® device also has ice wings which will not be used in this study, and only the body of the device will be used to provide vibration.
Covid-19 vaccination procedure with individuals in the control group: Individuals included in the control group will receive no intervention before the vaccination procedure, and the routine Covid-19 vaccination procedure will be used.
Immediately after the administration of the vaccination, an assistant researcher who is unaware of the injection method used will ask individuals from all groups to assess their pain levels with the Visual Comparison Scale and their satisfaction with the procedure by means of the Visual Individual Satisfaction Scale, and the scores will be recorded on the data collection forms.
详细描述
The aim of this study was to determine the effect on pain and satisfaction during the administration of Covid-19 vaccination of two different non-pharmacological methods: squeezing a stress ball and placing Buzzy® on the injection site.
The research was planned with a prospective, randomized controlled and experimental design. Data collection will take place at the Covid-19 Vaccination Clinic of the Health Research and Application Center of Bursa Uludağ University. The research sample will consist of individuals who on the date of the beginning of the data collection stage asked for or approved the Pfizer-BioNTech vaccination for themselves from the Turkish Ministry of Health, and who agreed to participate in the research.
The size of the study sample was statistically determined with the program G*Power 3.1.7. As a result of power analysis, the total minimum sample width was calculated as 120 people, with 40 in each group, accepting type I error level as 5% and in order to achieve an 80% power level. Individuals who meet the research criteria will be assigned to the implementation and control groups by means of a randomization list created by computer according to age and gender. That is, the group in which the individuals are placed will be determined by a randomization method according to a randomization list created on a computer.
Research data will be collected face to face, using an Individual Description Form, a Visual Comparison Scale and a Visual Individual Satisfaction Scale.
Individual Description Form: This form will contain questions on the individual's age, gender, education level, height, weight, and previous Covid-19 vaccinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The intervention and measurements were carried out by the researcher.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Approving the Pfizer-BioNTech vaccination from the Turkish Ministry of Health
- •Not having had an injection or vaccination in the deltoid muscle for at least three months
- •Participating voluntarily in the study
- •Being able to speak and understand Turkish
- •Being aged 18 years or older
- •Not having any vision or auditory problems
- •Not having any condition which might affect pain sensation
- •Not having developed any complication which would hinder a delta muscle injection.
排除标准
- •Not wanting to participate in the study, or during the course of the research, wishing to withdraw from the study
- •Having any condition which would affect the sensation of pain
- •Not being able to agree on a place or time
- •Being less than 18 years of age
结局指标
主要结局
Primary Outcome Measure-1
时间窗: 4 months
pain intensity in mm
Primary Outcome Measure-2
时间窗: 4 months
the individuals' state of satisfaction in mm
次要结局
- Secondary Outcome Measure-1(4 months)
- Secondary Outcome Measure-2(4 months)
- Secondary Outcome Measure-3(4 months)
研究者
Dilek Yilmaz
Bursa Uludag University, Department of Nursing
Uludag University