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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05752747
• Other study ID #: KAEK 07
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Vaccine

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Dilek alemdar	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	crying	crying time	1 minute before the procedure
Primary	crying	crying time will be measured and noted.	1 minute after the procedure
Primary	SpO2	Physiological parameters	1 minute before the procedure
Primary	SpO2	Physiological parameters	1 minute after the procedure
Primary	Pulse	Physiological parameters	1 minute before the procedure
Primary	Pulse	Physiological parameters	1 minute after the procedure
Primary	Body temperature	Physiological parameters	1 minute before the procedure
Primary	Body temperature	Physiological parameters	1 minute after the procedure
Primary	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
Primary	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