This study was a randomized controlled clinical trial conducted during routine vaccine injections.
Setting and samples
The research was conducted at a family health center (FHC) in the east of Turkey. According to records, this heath center had provided service for 11780 people and 352 infants during 2014. Data of the research was collected during working hours between March and June 2015. The research was carried out in vaccination room. The infants, whose mothers accepted to take part in the research, were brought to FHC at the end of first month for the second dose of Hepatitis B vaccine, and they were flicked at injection area just before they were vaccinated.
Population of the research includes all the infants who applied for second dose of Hepatitis B vaccine to FHC between March and June 2015.
Sample of the research includes the infants who applied for second dose of Hepatitis B vaccine to FHC during the research period and who met following criteria. Sample of the research includes 70 infants, 35 for experimental group, and 35 for control group. In the power analysis performed to determine the sample size, the calculated sample size was found to be 70 infants in order to achieve a 0.80 power in the test, at a significance level of 0.05 with a medium level of effect. Sample groups were randomly selected during the research period; the first infant arriving for vaccination was registered in the control group, whereas the second infant was registered in the experimental group, and so on. Each group included 35 infants.
The sample group, which was formed after written approval of parents, was selected by taking some criteria into consideration. Some of the criteria for infants are that gestational age is 37-42 weeks, term and healthy, birth weight is 2500 gr and above, 30-42 days old after birth, no previous treatment experience of intramuscular injection, no pain-killing medicine before vaccination.
Data Collecting Tools
The question form and Neonatal Infant Pain Scale(NIPS) were used in data collection and the infants’ responses to the procedure were video recorded.
This form, prepared by the researchers, based on relevant literature, comprised questions to collect participants’ demographic data, such as, gender, age, weight, duration of crying (1, 6, 10, 11, 18, 19). The form was filled out during face-to-face interviews held with the parents of the infants, who had volunteered to participate in the study.
Neonatal Infant pain Scale (NIPS)
NIPS was developed to evaluate neonate infants’ behavioral pain response before, during, and after injection attempt by Lawrance et al., (20). Validity and reliability for Turkish were completed by Akdovan in 1999 (21). Neonate infant pain scale is formed by 6 behavioral sections including facial expression, crying, breathing style, arm and leg movements, and being woken up. Crying has 3 points (0-1-2), and other behaviors have 2 points (0-1). Total score is between 0 and 7. Higher score shows that the pain is more intense. Akdovan found Cronbah alpha scores as 0,83-0,83-0,86 in his study (19, 21) Internal consistency Cronbach Alpha score of this scale was detected 0.81 before, 0.76 during, and 0.78 after operation.
Subsequently, research was carried out with those infants whose parents were willing to participate after informed consents were obtained from them. Data collection forms were completed by researchers. Neonates in both control and experimental group were vaccinated by the same staff working in the family health center (FHC). All infants were awake, had clean diapers at the time of injection, and their parents were in the procedure room.
The infants in the control group were regularly vaccinated, without any other attempt in FHC, and they were videotaped before, during, and after the vaccination. During the vaccination procedure, the parents of infants in both groups were allowed to calm their babies by touching and talking to them, but not to feed and do anything that would distract the infant’s attention, including giving them toys, showing them a dummy, or clapping.
Routine application of Hepatitis B vaccine
The infant was laid back, and the vaccination area was marked. The Hepatitis B vaccine was intramuscularly (IM) injected. The injection site was located at the ventrolateral section of the vastus lateralis muscle, which is in the upper 1/3 part of the thigh. The vaccination area was disinfected with alcohol, and the vaccine was injected into the upper 1/3 section of the vastus lateralis muscle at 90-degree angle.
Each infant in the experimental group was flicked once at the vaccination area (vastus lateralis) prior Hepatitis B vaccination.
The Nurse determined the vaccination area and disinfected it using cotton with 70 % alcohol. The muscle was held with the nurse’s left hand, and the vaccination area was flicked with the right hand. The flick was given as follows: the thumb was placed on the nail of middle finger, then the vaccination area was stimulated with a quick tap using upper nail part of middle finger (Fig. 1).
It was ensured that the hands of flicking staff were warm, and nails were clipped in order not to harm the infant. The staff waited to start the procedure until the infant calm down, if it was anxious; the procedure was not initiated if the infants were crying.
Infants in both the experimental and control group were videotaped before, during, and after vaccination until they stopped crying. After vaccination, filming was continued for 1 min, and, following ethical principles, the mothers were allowed to comfort their babies that continued crying for >1 min. Video records lasted about 1.5 - 2 min. The infant’s whole body and the crying sounds, which were indicative of pain, (22) were video recorded using a Canon Ixus 75 7.1 MP digital video camera.
The procedure was recorded using a video camera. Video records were evaluated independently by two specialist observers (pediatric specialist nurse, neonatal doctor). Observers were not informed which newborn belonged to the control group and which newborn belonged to the treatment group. After records were completed, they were evaluated twice by two experts at different times. Observers scored the NIPS by evaluating the pain experienced by the newborns. The concordance coefficient was calculated between observers. Average Neonatal Infant Pain Scale (NIPS) scores were calculated at the end of evaluations. Observers’ evaluations were found consistent (for each of 6 categories of NIPS, Kappa observers consistency test gives the result in range of 0.48 and 0.71).
The duration of neonates’ crying (sec) was recorded from the video records.
Data from the research were evaluated in SPSS (Statistical Package for Social Sciences) 13.0 software package. Percentage distribution, average, standard deviation, chi-square test, cronbach alpha coefficient of consistence, chi-square in comparing the groups, Independent Sample t test, and One-way Analysis of Variance were used in analysis of research results. P < 0.05 was considered significant in all analyses.
The study was approved by the local institution based on regulation No 2015.3/1 by the Ethical Board of Kafkas University, Medicine School. As responses should be given voluntarily in all researches, whereby information is obtained, it was ensured that the parents of the infants to be included in the study were volunteers. Moreover, the parents of the infants were informed of the aim and protocol of the research (why the babies were recorded, and for what purpose these recordings were going to be used), and both their written and oral consents (informed consent principle) were received (23). All infants’ parents agreed to fill out the question form and were aware that the video recording was going to be short and that their babies were not going to be imposed with any extra burden.