The Effect on Pain and Satisfaction of Two Different Non-Pharmacological Methods Used During Coronavirus (Covid-19) Vaccination
1 other identifier
interventional
120
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedStudy Start
First participant enrolled
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedAugust 24, 2022
August 1, 2022
3 months
August 21, 2022
August 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Outcome Measure-1
pain intensity in mm
4 months
Primary Outcome Measure-2
the individuals' state of satisfaction in mm
4 months
Secondary Outcomes (3)
Secondary Outcome Measure-1
4 months
Secondary Outcome Measure-2
4 months
Secondary Outcome Measure-3
4 months
Study Arms (3)
The stress ball group
EXPERIMENTALWith 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.
The Buzzy® group
EXPERIMENTALIndividuals 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.
The control group
NO INTERVENTIONIndividuals included in the control group will receive no intervention before the vaccination procedure, and the routine Covid-19 vaccination procedure will be used.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elmas Baki, MSc
Bursa Uludağ University Health Applications Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The intervention and measurements were carried out by the researcher.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Bursa Uludag University, Department of Nursing
Study Record Dates
First Submitted
August 21, 2022
First Posted
August 24, 2022
Study Start
August 30, 2022
Primary Completion
November 15, 2022
Study Completion
November 30, 2022
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share