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NCT Number: NCT05752747

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

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Key information

Conditions

Vaccine Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cold Massage Group

Other

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

Other

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.

Primary outcomes

  1. crying

    Time frame: 1 minute before the procedure

    crying time

  2. crying

    Time frame: 1 minute after the procedure

    crying time will be measured and noted.

  3. SpO2

    Time frame: 1 minute before the procedure

    Physiological parameters

  4. SpO2

    Time frame: 1 minute after the procedure

    Physiological parameters

  5. Pulse

    Time frame: 1 minute before the procedure

    Physiological parameters

  6. Pulse

    Time frame: 1 minute after the procedure

    Physiological parameters

  7. Body temperature

    Time frame: 1 minute before the procedure

    Physiological parameters

  8. Body temperature

    Time frame: 1 minute after the procedure

    Physiological parameters

  9. FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)

    Time frame: 1 minute before the procedure

    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.

  10. FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)

    Time frame: 1 minute after the procedure

    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.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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