Clinical trial NCT05752747: The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters in Babies
Official title: The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters During Vaccine Injection in Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine
Pain
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 108
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was planned as randomized controlled experimental.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: crying
timeFrame: 1 minute before the procedure
measure: crying
timeFrame: 1 minute after the procedure
measure: SpO2
timeFrame: 1 minute before the procedure
measure: SpO2
timeFrame: 1 minute after the procedure
measure: Pulse
timeFrame: 1 minute before the procedure
measure: Pulse
timeFrame: 1 minute after the procedure
measure: Body temperature
timeFrame: 1 minute before the procedure
measure: Body temperature
timeFrame: 1 minute after the procedure
measure: FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)
timeFrame: 1 minute before the procedure
measure: FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)
timeFrame: 1 minute after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Dilek alemdar
Study officials:
affiliation: Assoc. Dr.
name: Dilek Küçük Alemdar
role: PRINCIPAL_INVESTIGATOR
References: