The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters in Babies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
The sample size of the research will be determined with the help of power analysis. All calculations in the power analysis made G-Power 3.1.9.2. carried out through the program. In the power analysis, the effect size was determined by using the Cohen standard effect sizes, which are frequently used in the literature (Cohen, 1997). In the study, the type I error level, also known as false positivity and generally called α error, which expresses the possibility of finding an effect, difference or relationship that does not exist in reality, was accepted as 0.05 in the power analysis. On the other hand, II. error, known as false negativity, which is expressed as the probability of showing an effect, difference or relationship as if the results of the study do not exist, and which is generally called ß error. The type error level was accepted as 0.20. In this case, this work will be carried out with 80% power. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cold 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. |
Other: Cold 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.
|
| Experimental: ShotBlocker© 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. |
Other: ShotBlocker© 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.
|
| No Intervention: Control Group No intervention will be applied to the control group. |
Outcome Measures
Primary Outcome Measures
- crying [1 minute before the procedure]
crying time
- crying [1 minute after the procedure]
crying time will be measured and noted.
- SpO2 [1 minute before the procedure]
Physiological parameters
- SpO2 [1 minute after the procedure]
Physiological parameters
- Pulse [1 minute before the procedure]
Physiological parameters
- Pulse [1 minute after the procedure]
Physiological parameters
- Body temperature [1 minute before the procedure]
Physiological parameters
- Body temperature [1 minute after 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.
- FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale) [1 minute after 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The baby is 2-6 months old,
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DaBT- IPA- Hib vaccine will be administered,
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The baby does not have a chronic disease,
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Parents must be at least primary school graduate,
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Parent's willingness to participate in the study.
Exclusion Criteria:
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Having a congenital or neurological health problem,
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Have taken an analgesic drug in the last 4 hours,
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Babies with a body temperature above 37.5 will not be included in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dilek alemdar | Ordu | Turkey | 52000 |
Sponsors and Collaborators
- T.C. ORDU ÜNİVERSİTESİ
Investigators
- Principal Investigator: Dilek Küçük Alemdar, Assoc. Dr.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KAEK 07