The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters in Babies

The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters During Vaccine Injection in 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.

Study Overview

• Status: Completed
• Conditions: Pain; Vaccine
• Intervention / Treatment: Other: Cold Massage Group; Other: ShotBlocker© Group

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey, 52000
    • Dilek alemdar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ
• Investigators: Principal Investigator: Dilek Küçük Alemdar, Assoc. Dr.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: KAEK 07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No