The Effect of Mechanical Vibration and Flick Tapping Methods in Reducing Pain During Hepatitis B Vaccine Administration in Infants
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice, Health Behavior
Sponsor: Berrin GOGER

Republic of Turkey 
Black Sea Technical University Rectorate 
Directorate of the Institute of Health Sciences 
Number: 27863166-302.14.04- 02/22/2024                                                             22.02.2024 
Subject: Thesis Proposal (Berrin GÖGER) 
TO THE DEPARTMENT OF NURSING 
Regarding the “Doctoral Thesis Proposal” of Berrin GÖĞER, a doctoral student in your 
department, a copy of the Institute Management Board decision dated 14.02.2024 and 
numbered 160 is attached. I kindly request your attention and action. 
 
 
Assistant Professor Efnan ABDIOĞLU FAZLI 
Director a. 
Deputy Director of the Institute 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

DETAİLED DESCRİPTİON OF THE WORK 
Title of the study 
The effect of mechanical vibration and flicking methods on reducing pain during the Hepatitis 
B vaccine administration in infants 
General Information 
The International Association for the Study of Pain defines pain as “an unpleasant sensory and 
emotional experience associated with actual or potential tissue damage” (1). The International 
Classification of Nursing Practice (2019) defines pain as “perceptual disorder: increased 
unpleasant sensations in the body, subjective reporting of pain, grimacing, changes in muscle 
tone, self-protection.” It has been defined as “behavior, narrowing of attention focus, altered 
perception of time, withdrawal from social contact, impaired thought processes, distracting 
behaviors, restlessness, and loss of appetite” (2). 
The American Pain Society has defined pain as the fifth vital sign and emphasized that 
healthcare professionals should systematically assess pain in the same way they assess 
temperature, pulse, respiratory rate, and blood pressure (3). The Turkish Language Association 
(TDK) defines pain as a feeling of discomfort arising from the intense stimulation of nerve 
endings anywhere in the body (4). Although pain is subjective, its definitions are based on 
previous pain experiences, and it is noted that early life experiences related to pain shape future 
pain responses (5, 6). 
Short-term effects of untreated procedural pain in infancy and early childhood include delayed 
wound healing, changes in immune system function, endocrine and biochemical changes, 
increased cortisol and catecholamine release, increased glucagon, growth hormone, 
aldosterone, renin, and antidiuretic hormone levels, and decreased insulin secretion. In addition, 
physiological changes such as apnea, bradycardia, tachycardia, skin color changes, 
hypertension, sweating of the palms, increased intracranial pressure, respiratory rate, and 
muscle tone, as well as behavioral changes and crying, are also present (7). It is also noted that 
it causes long-term sequelae, including anticipatory anxiety (8). These effects include decreased 
analgesic efficacy, increased sensitivity to pain and needle phobia, avoidance of routine health 
care checkups, and a tendency not to comply with medical treatment and preventive measures 
(6). 
From birth and throughout infancy, they are routinely exposed to painful procedures as part of 
routine preventive care (15). Depending on their stage of development, they may lack the 
communication skills and cognitive development necessary to describe the nature, location, 
severity, or intensity of their pain. It is a complex, multidimensional, and subjective condition 
that can be difficult to assess and manage, especially in infants and young children (16). 
However, ensuring a thorough assessment of their physiological status during painful 
procedures and developing evidence-based, appropriate pain control strategies with an 
understanding of the effects of pediatric pain is both a medical and ethical responsibility for 
pediatric nurses (1, 17). The World Health Organization (WHO) estimates that 12 billion It is 
estimated that injections are administered, with approximately 5% of these being childhood 
vaccinations (6).  Pain associated with vaccination is considered a significant adverse event 
following vaccination and therefore pain management should be part of every vaccination (9). 

To minimize these adverse events, the American Academy of Pediatrics and the International 
Neuropsychiatric Pain Group recommend reducing pain in infants and using non-
pharmacological pain relief methods as the primary option in newborns (18, 19). Studies 
indicate that non-pharmacological tactile stimuli such as vibration may have the potential to 
reduce pain due to the presence of numerous large fibers in the skin (11, 20-22). Infants are 
exposed to mechanical vibration through vibrating infant seats or swings to calm them in both 
hospital and home settings (23). However, it is known that vibration applied with a mechanical 
hand vibrator is also used as a method of chest physiotherapy in Neonatal Intensive Care Units 
(NICUs) to calm colicky infants (24, 25). 
It has been suggested that manipulations such as rubbing, applying pressure, and tapping 
directly on or below painful areas may also alleviate pain by releasing beta-endorphins into the 
bloodstream (13). It has been suggested that simple manual pressure applied to the injection 
site (similar in effect to the fiske method) may be a useful technique for reducing injection pain 
(7, 13, 26). The current literature shows that non-pharmacological mechanical vibration and 
fiske applications may be effective in reducing injection pain (7, 11). 
Based on this information, the aim is to evaluate the effect of mechanical vibration and fiske 
tapping methods in reducing pain during vaccination in one-month-old infants receiving 
healthcare as part of routine primary preventive healthcare services. 
Aim 
This study aims to investigate the effect of tapping the injection site prior to the second dose of 
Hepatitis B vaccine administered to the anterior surface of the vastus lateralis muscle during 
infancy and the application of mechanical vibration to the injection site throughout the 
vaccination procedure on acute pain, crying duration, and physiological parameters that may 
occur due to intramuscular injection. 
Research Hypotheses 
Main Hypotheses 
Hypothesis 0a (H0a): There is no difference in pain between the control group and the study 
groups when mechanical vibration is applied during Hepatitis B vaccination in infants 
compared to routine Hepatitis B vaccination.  
Hypothesis 1a (H1a): There is a difference in pain between the control group and the study 
groups when mechanical vibration is applied during Hepatitis B vaccination in infants 
compared to routine Hepatitis B vaccination. 
Hypothesis 0b (H0b): There is no difference in pain between the control group and the study 
groups when comparing the routine Hepatitis B vaccination with the tap method applied during 
Hepatitis B vaccination in infants. 
Hypothesis 1b (H1b): There is a difference in pain between the control group and the study 
groups in infants during routine Hepatitis B vaccination and during Hepatitis B vaccination 
administered using the finger-prick method. 
 
 

Method 
Type of Research 
The research is planned to be conducted as a randomized controlled trial to examine the 
analgesic and physiological effects of mechanical vibration and fiske methods in infant 
vaccinations.  
Location and Timing of the Research 
Research data will be collected at Gümüşhane Kelkit No. 1 ASM. According to the study 
schedule, ethical committee and institutional approval will be obtained before starting the 
research, following the submission and acceptance of the thesis proposal, and then the data 
collection process will begin. Data collection, obtaining expert opinions, and data entry will 
take place over a 12-month period. Data analysis and thesis report writing will be completed 
within a three-month period, and the research is expected to be carried out according to the 
planned schedule. 
Ethical Aspects of the Study 
Before starting the study, the necessary permissions will be obtained from the Scientific 
Research Ethics Committee of Karadeniz Technical University Health Sciences. After 
obtaining permission from the ethics committee, institutional permission will be obtained from 
the Gümüşhane Provincial Health Directorate, to which Gümüşhane Kelkit No. 1 ASM is 
affiliated, in order to carry out the study. All parents of newborn babies included in the study 
will be informed about the purpose, type, implementation process, and content of the study, the 
purpose for which the video images taken during the data collection process will be used, the 
fact that all data will be stored on the researcher's personal computer, and where the obtained 
data will be used. Verbal and written consent will be obtained from the parents. 
Study Population and Sample 
The study population will include infants whose mothers, who agreed to participate in the study, 
applied for the second dose of the Hepatitis B vaccine at the end of the first month as part of 
routine preventive care at Gümüşhane Kelkit No. 1 ASM and who met the inclusion criteria for 
the study. 
A power analysis was performed to select the patients to be sampled. The G*Power 3.1.9 
program was used to calculate the number of participants to be included in the study. During 
the calculation, the effect size was taken as 0.31 based on Kanbur's (2021) study for the 
parameters specified according to the type of test, the margin of error was taken as 0.05, the 
power value was taken as 0.80, the number of groups was taken as 3, and the number of 
measurements was taken as 3. The calculation resulted in a minimum participant number of 72. 
Accordingly, it was planned to include a minimum of 24 participants in each group (27). 
Research Inclusion Criteria 
The parent agrees to participate in the study/volunteers to participate, 
The gestational age is between 38 and 42 weeks, 
The birth weight is between 2500 g and 4000 g, 

No pain medication is administered prior to vaccination, 
Body temperature is within normal limits, 
Exclusion Criteria 
Parents who do not consent to participate in the study, 
Gestational age below 38 weeks or above 42 weeks, 
Infants with congenital diseases or birth defects will not be included in the study. 
Data Collection Tools 
Newborn Baby Identification Form  
The newborn infant information form created by the researcher consists of a total of nine 
questions, including the infant's group number, gender, gestational age, mode of delivery, birth 
weight and length at birth, postnatal age, current weight and height, and feeding method (27, 
29). 
Parent Information Form  
The parent information form created by the researcher consists of a total of six questions, 
including the parent's group number, mother and father's ages, education status, and occupation 
information (27). 
Newborn Baby Observation Form  
The observation form prepared by the researcher is a form on which physiological parameters 
will be recorded, including the baby's group, crying time with the start of the vaccination 
procedure, the baby's body temperature before and after the procedure, the baby's respiratory 
rate before and after the procedure, and oxygen saturation and heart rate before, during, and 
after the procedure. This information about the infant before, during, and after the procedure 
will be observed by the researcher and recorded on this form (27, 29). 
Neonatal Infant Pain Scale (NIPS)   
Developed by Lawrence and colleagues, it is used to measure the behavioral responses to pain 
in preterm and term infants during the first six weeks after birth. The scale ensures that the 
infant's behavior, which is the first step in meeting the newborn's needs, is objectively assessed 
at the bedside. The scale's reliability coefficient has been found to be between 0.92 and 0.97. It 
is stated that the scale can be used reliably and can measure the effectiveness of the intervention, 
and six behaviors in response to pain are evaluated (27). Facial expression, breathing pattern, 
arm movements, leg movements, and alertness are scored as 0 or 1, while crying is scored as 0, 
1, or 2. The total score ranges from 0 to 7, with a high score indicating severe pain. The Turkish 
adaptation of the scale was performed by Akdovan and Çiğdem in 1999 (28). 
Application Tools 
Mechanical Vibrator 

The Norco NC70209 brand mini vibration device, which is lightweight, portable, and battery-
operated, with silicone heads for small areas, vibrates at 5500 rpm and is intended for use on 
infants in the mechanical vibration group. 
Video Camera 
The digital camera of the Samsung Galaxy M31 phone is planned to be used to determine pain 
levels before, during, and after the Hepatitis B vaccination procedure in infants, to evaluate 
physiological parameters, to accurately calculate crying times, and to check for inter-observer 
agreement in the evaluation of pain scores. The camera has an 8-megapixel video resolution 
and features that allow images to be reviewed on a wide screen. 
Pulse Oximeter 
An ACCURATE handheld rechargeable pulse oximeter device is planned to be used at the 
patient's bedside to easily view measurement trends on the screen for determining oxygen 
saturation and heart rate in infants. The device is designed to monitor pulse and blood oxygen 
levels in premature infants, newborns, children, and adults. Values can be tracked by attaching 
it to the adjustable wrist, ankle, or finger. 
Thermometer 
A KANGJI brand, model GQ-129, non-contact infrared digital screen thermometer is planned 
to be used to measure the body temperature of infants. Body temperature measurement will be 
taken from the forehead, and the thermometer will be held 3-5 cm away from the infant's 
forehead. 
Data Analysis 
IBM SPSS 27 software will be used to analyze the data in this study. Continuous data will be 
presented as mean ± standard deviation, while categorical data will be presented as frequency 
and percentage. If the values obtained from the measurements taken for each variable 
throughout the study show a normal distribution, the parametric test ANOVA test will be used 
to compare repeated measurement results. If the values do not show a normal distribution, the 
non-parametric Friedman test will be used. For intergroup analyses, the parametric test, one-
way ANOVA, will be used for those showing a normal distribution, and the non-parametric 
test, Kruskal Wallis H test, will be used for those not showing a normal distribution. Statistical 
significance will be accepted as p<0.05 for all analyses. 
Research 
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