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

T.C. ORDU ÜNİVERSİTESİ

Status: Completed

Conditions: Vaccine; Pain

Treatments: Other: ShotBlocker© Group; Other: Cold Massage Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05752747

KAEK 07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 2 to 6 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups

Cold Massage Group

Experimental group

Description:

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.

Treatment:

Other: Cold Massage Group

ShotBlocker© Group

Experimental group

Description:

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.

Treatment:

Other: ShotBlocker© Group

Control Group

No Intervention group

Description:

No intervention will be applied to the control group.