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NCT Number: NCT04990648

Buzzy® Application in Pain

The research was conducted as a randomized controlled experiment to investigate the effect of Buzzy® on pain level during the measles-rubella-mumps (MMR) vaccine injection in 12-month-old infants. This study was done with infants meeting the sampling criteria (buzzy group: 30, control group: 30) on November 2018-May 2019 in Istanbul Bakirkoy 9 Family Health Center.

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Key information

Conditions

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

Age range

12 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Okan University

Tuzla, Istanbul, 34959, Turkey (Türkiye)

About this study

To determine the effect of Buzzy® application on pain, which is a combination of cold and vibration, during measles-rubella-mumps (MMR) vaccine injection administration on 12-month-old infants. The study is a randomized contrlled experimental research. The research sample is composed of 60 infants (buzzy:30, control:30) who are 12-month-old injected MMR vaccine at Bakırköy No. 9 Family Health Center between November 2018-May 2019. As a data collection tool Data Collection Form, FLACC Pain Scale and Buzzy® device have been used. While Buzzy® was applied on infants in the trial group before, during and after the vaccine injection, the infants in the control group were applied routine vaccine injection. The pain response of the infants was evaluated by the nurse and the parent before, during and after the vaccine injection and the physiological parameters were evaluated by the nurse before and after the vaccine injection.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The baby has completed 12 months,
  • MMR vaccine will be applied,
  • Being at a suitable weight for the month,
  • The baby has not been given analgesic medication during the day,
  • It can be listed as the parent's willingness to participate in the research.

Exclusion criteria

  • It can be listed as having a body temperature above 37.5.

Treatment and study plan

Buzzy

Device

Buzzy ® device (Buzzy ® Mini Healthcare) has been used to reduce pain by using local cold application and vibration effect. Buzzy ® was developed by Dr. Amy Baxter in 2009. The size of the Buzzy ® device measures 2⅞ꞌꞌ x 1⅞ꞌꞌ x ⅞ꞌꞌ (7,2 cm x 4,8 cm x 2,2 cm). It is a bee-shaped device made of hard plastic with a vibrating motor (2 settings - fixed and pulsed), powered by a 2AAA battery. There are 4 ice packages and elastic fastening strap. On the part where the device touches the skin, there is an ice package in the shape of a wing. When the button on the device is pressed, it vibrates.

Primary outcomes

  1. The effect of Buzzy® administered during vaccine injection on the infant's pain level before vaccine injection.

    Time frame: 30 seconds

    FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).

  2. The effect of Buzzy® administered during vaccine injection on the infant's pain level during vaccine injection.

    Time frame: 30 seconds

    FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).

  3. The effect of Buzzy® administered during vaccine injection on the infant's pain level after vaccine injection.

    Time frame: 30 seconds

    FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).

  4. The effect of Buzzy® administered during vaccine injection on the infant's pulse before vaccine injection.

    Time frame: 30 seconds

    pulse rate

  5. The effect of Buzzy® administered during vaccine injection on the infant's pulse after vaccine injection.

    Time frame: 30 seconds

    pulse rate

  6. The effect of Buzzy® administered during vaccine injection on infant blood pressure before vaccine injection.

    Time frame: 30 seconds

    blood pressure

  7. The effect of Buzzy® administered during vaccine injection on infant blood pressure after vaccine injection.

    Time frame: 30 seconds

    blood pressure

  8. The effect of Buzzy® administered during vaccine injection on the infant's SpO2 before vaccine injection.

    Time frame: 30 seconds

    SpO2

  9. The effect of Buzzy® administered during vaccine injection on the infant's SpO2 after vaccine injection.

    Time frame: 30 seconds

    SpO2

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

The Effect of Buzzy® Application on the Pain Level During Vaccine Injection in Infants

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 4, 2021
Registry last updated
Aug 4, 2021

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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