Pain, Vaccine
Conditions
Brief summary
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.
Detailed description
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.This study was planned as randomized controlled experimental single-blind. The population of the research will be 2-6 months old babies who come to Giresun Güce District State Hospital Family Health Center to receive DaBT-IPA-Hib vaccine between the dates of the research. The sample of the study will consist of infants who met the case selection criteria, accepted to participate in the study and were vaccinated between the specified dates. As a result of the power analysis, it was determined that a total of 99 infants, 33 of whom were to be applied cold massage, 33 to be administered ShotBlocker©, and 33 to the control group, who were 2-6 months old to be administered DaBT-IPA-Hib vaccine, met the case selection criteria and agreed to participate in the study. Considering the possibility of case losses, a total of 108 babies, 36 in each group, are planned to be included in the study.
Interventions
OTHERCold Massage Group
Just before the application, it will be taken out of the cabinet and the area to be vaccinated will be massaged with rollers with back and forth movements.
OTHERShotBlocker© Group
It is a small flexible drug-free plastic tool. It is a small, flat-shaped instrument with a short, blunt, skin-contact ridge on the bottom and a hole in the center to inject. It is placed on the skin before injection. The protrusions on the inside do not harm the skin.
Sponsors
Ordu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In order to prevent selection bias, the assignment of infants to groups will be made using stratification and randomization methods with blocks. Parents will not be informed which group their baby is in (ShotBlocker©, cold massage, control). In the study, the pain level of the infants will be evaluated by the family health worker, the researcher and their parents who administered the vaccine. At the end of the study, inter-observer agreement will be evaluated. Parents and family health workers will be informed by the researcher about the pain scale to be used in the research. In addition, the database of the research will be created by a university graduate statistician working in a statistical center independent of the research, apart from the researcher.
Intervention model description
This study was planned as randomized controlled experimental.
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* The baby is 2-6 months old, * DaBT- IPA- Hib vaccine will be administered, * The baby does not have a chronic disease, * Parents must be at least primary school graduate, * Parent's willingness to participate in the study.
Exclusion criteria
* Having a congenital or neurological health problem, * Have taken an analgesic drug in the last 4 hours, * Babies with a body temperature above 37.5 will not be included in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| crying | 1 minute before the procedure | crying time |
| SpO2 | 1 minute before the procedure | Physiological parameters |
| Pulse | 1 minute before the procedure | Physiological parameters |
| Body temperature | 1 minute before the procedure | Physiological parameters |
| FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale) | 1 minute before the procedure | The FLACC scale was first developed by Merkel et al.in 1997. In the research, it will be used to evaluate the pain levels of infants in the experimental and control groups before, during and after vaccination. The five behaviors (face, legs, activity, crying and consolation) evaluated on this scale are considered indicators of pain that can be detected and graded by an observer. Descriptors for each item are accepted as indicators of children's painful behavior. Each item is scored from 0 to two, resulting in a pain intensity score ranging from 0 to 10. And descriptors associated with each score level represent pain intensity. |
Countries
Turkey (Türkiye)
Outcome results
None listed