Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05514262 |
| Other study ID # |
2022/15-2 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 30, 2022 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Uludag University |
| Contact |
Dilek Yilmaz, PhD |
| Phone |
+905073580330 |
| Email |
dilekk[@]uludag.edu.tr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Visual Comparison Scale (VCS): The VCS is a 10-cm-long scale used to assess pain intensity
felt during a procedure. One end represents no pain, and the other end the most severe pain
possible. In this study, a vertical scale will be used.
Visual Individual Satisfaction Scale: The individuals' state of satisfaction during the
administration of the vaccination will be assessed with the Visual Individual Satisfaction
Scale, which consists of a 10-cm vertical line, at one end of which is written "I am very
satisfied" and at the other "I am not at all satisfied".
Close attention will be paid to Covid-19 precautions when collecting research data. After
confirming the voluntary participation of the individuals, they will be assigned to the
intervention and control groups. After that, their descriptive characteristics will be
recorded on a data collection form, and then they will be given information on the use of the
Visual Comparison Scale and the Visual Individual Satisfaction Scale.
All of the individuals will receive the vaccination with the use of the 1-ml syringes
distributed specifically for the vaccinations according to the specifications of the Turkish
Ministry of Health. All vaccinations will be given to the deltoid muscle as one dose (0.3ml).
It is planned that all vaccinations will be administered by the same nurse working in the
Vaccination Unit, with individuals in an appropriate sitting position, into the deltoid
muscle of the left upper arm at an angle of 90° and without aspiration. Determination of the
deltoid area where the vaccination will be administered will be achieved in this way: an
imaginary horizontal line will be drawn on the outside surface of the arm to which the
vaccination is to be administered to the end of the humerus; each end of this imaginary line
will join in the axillary alignment to form an inverted triangle, and the area in the middle
of the triangle will be used as the injection area. The standard vaccination administration
procedure steps will be followed for all individuals in the intervention and control groups.
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.
