The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters in Babies
- Conditions
- VaccinePain
- Interventions
- Other: Cold Massage GroupOther: ShotBlocker© Group
- Registration Number
- NCT05752747
- Lead Sponsor
- T.C. ORDU ÜNİVERSİTESİ
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cold Massage Group 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. ShotBlocker© Group 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.
- Primary Outcome Measures
Name Time Method Body temperature 1 minute after the procedure Physiological parameters
SpO2 1 minute after the procedure Physiological parameters
Pulse 1 minute after the procedure Physiological parameters
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.
crying 1 minute after the procedure crying time will be measured and noted.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dilek alemdar
🇹🇷Ordu, Turkey