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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold Massage Group | Experimental | 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. |
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| ShotBlocker© Group | Experimental | 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. |
|
| Control Group | No Intervention | No intervention will be applied to the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Massage Group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| crying | crying time | 1 minute before the procedure |
| crying | crying time will be measured and noted. | 1 minute after the procedure |
| SpO2 | Physiological parameters | 1 minute before the procedure |
| SpO2 | Physiological parameters | 1 minute after the procedure |
| Pulse | Physiological parameters | 1 minute before the procedure |
| Pulse | Physiological parameters | 1 minute after the procedure |
| Body temperature | Physiological parameters | 1 minute before the procedure |
| Body temperature | Physiological parameters | 1 minute after the procedure |
| FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dilek Küçük Alemdar | Assoc. Dr. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dilek alemdar | Ordu | 52000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study was planned as randomized controlled experimental.
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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.
| ShotBlocker© Group | Other | 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. |
|
| 1 minute before the procedure |
| FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale) | 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. | 1 minute after the procedure |