Official Title
The Effect on Pain and Satisfaction of Two Different Non-Pharmacological Methods Used During Coronavirus (Covid-19) Vaccination
Brief Summary

The aim of this study was to determine the effect on pain and satisfaction during theadministration 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 experimentaldesign. Data collection will take place at the Covid-19 Vaccination Clinic of the HealthResearch and Application Center of Bursa Uludağ University. The research sample willconsist of individuals who on the date of the beginning of the data collection stageasked for or approved the Pfizer-BioNTech vaccination for themselves from the TurkishMinistry 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 120people, with 40 in each group, accepting type I error level as 5% and in order to achievean 80% power level. Individuals who meet the research criteria will be assigned to theimplementation and control groups by means of a randomization list created by computeraccording to age and gender.Research data will be collected face to face, using an Individual Description Form, aVisual Comparison Scale and a Visual Individual Satisfaction Scale.The following interventions will be performed on the individuals in the interventiongroup in addition to the standard vaccination procedure:Covid-19 vaccination procedure with individuals in the stress ball group: With thisgroup, a yellow stress ball will be used which is 6cm in diameter, of medium hardness andmade of high quality silicone, and which returns to its original shape after beingsqueezed. The researcher will explain to the individuals in the group how they should usethe 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 onwhich the vaccination will not be given, and, counting from one to three, to squeeze andrelease the ball, continuing until the procedure is finished. It will be explained thatduring the procedure, they should give their attention to the stress ball and focus onsqueezing it.Covid-19 vaccination procedure with individuals in the Buzzy® group: Individuals in thisgroup will use the Buzzy® device. Before the vaccination procedure, the researcher willplace the Buzzy® device, which will be at room temperature, on the vaccination site, andit will vibrate in a non-discomforting way for one minute. After this, the Buzzy® devicewill 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 vaccinationprocedure, and re-used with other individuals. The Buzzy® device also has ice wings whichwill not be used in this study, and only the body of the device will be used to providevibration.Covid-19 vaccination procedure with individuals in the control group: Individualsincluded in the control group will receive no intervention before the vaccinationprocedure, and the routine Covid-19 vaccination procedure will be used.Immediately after the administration of the vaccination, an assistant researcher who isunaware of the injection method used will ask individuals from all groups to assess theirpain levels with the Visual Comparison Scale and their satisfaction with the procedure bymeans of the Visual Individual Satisfaction Scale, and the scores will be recorded on thedata collection forms.

Detailed 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.

Unknown status
Individual Satisfaction
Pain Management

Other: The stress ball

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.

Device: The Buzzy® device

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.

Eligibility Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Locations

Not Provided

Contacts

Dilek Yılmaz, PhD
+905073580330
dilekk@uludag.edu.tr

Münevver Kutlu, BN
+905079037634
201910003@ogr.uludag.edu.tr

Elmas Baki, MSc, Study Chair
Bursa Uludağ University Health Applications Research Center

The Scientific and Technological Research Council of Turkey
NCT Number
Keywords
Covid-19
COVID-19 vaccine
pain control
nonpharmacological method
satisfaction
MeSH Terms
COVID-19