The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters in Babies
NCT ID: NCT05752747
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2022-11-22
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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
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.
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.
Control Group
No intervention will be applied to the control group.
No interventions assigned to this group
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Months
6 Months
ALL
Yes
Sponsors
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Ordu University
OTHER
Responsible Party
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Dilek Kucuk Alemdar
Associate professor
Principal Investigators
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Dilek Küçük Alemdar
Role: PRINCIPAL_INVESTIGATOR
Assoc. Dr.
Locations
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Dilek alemdar
Ordu, , Turkey (Türkiye)
Countries
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Other Identifiers
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KAEK 07
Identifier Type: -
Identifier Source: org_study_id
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