Effects of Buzzy® and ShotBlocker® on Pain, Anxiety and Satisfaction During the Administration of Vaccine

NCT06397352 | Completed

• 1 other identifier: MehmetAkifU-SBF-HEÖ-02
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to detect and compare the effects of ShotBlocker® and Buzzy® methods on pain, anxiety, and satisfaction during the administration of Tetanus-Diphtheria vaccine to school-aged children. This study was an experimental randomized controlled trial. The sample was included 138 children in a family health centers aged 13 years who underwent Tetanus-Diphtheria vaccine. The participants were randomly assigned to ShotBlocker®, Buzzy®, and control groups. Each group included 46 children, of whom 23 were female and 23 were male. The State-Trait Anxiety Inventory and Visual Analog Scale were used to collect the data.

Conditions

Pain; Anxiety; Satisfaction

Keywords

Buzzy; Shotblocker; pain; anxiety; satisfaction; vaccine

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  This scale consists of a 10-cm line (0-10 cm or 0-100 mm). The 0-line on the scale indicates "no pain," and the 10-line indicates "unbearable pain." The child is asked to mark the place that expresses the degree of pain. The distance from the point marked by the child to the 0 line is measured to determine the degree of pain. In children aged 8 and above, the Visual Analog Scale (VAS) is considered the most reliable method.

  Visual Analog Scale were completed immediately after the vaccination.

Secondary Outcomes (2)

• State-Trait Anxiety Inventory (STAI)

  State-Trait Anxiety Inventory (STAI) were completed immediately after the vaccination

• Satisfaction level

  Satisfaction were completed immediately after the vaccination

Study Arms (2)

ShotBlocker® Group

EXPERIMENTAL

The ShotBlocker® is a small, flexible, drug-free plastic device with several short, blunt skin contact points on the bottom and a hole in the center through which injections can be administered. It is positioned onto the skin before an injection is made. After positioning the ShotBlocker® and ensuring that the contacts were in contact with the children's skin, the injection was made through the central hole by the nurse. The ShotBlocker® was cleaned with 70% alcohol before use on another child.

Other: ShotBlocker®

Buzzy® Group

EXPERIMENTAL

Buzzy is a small plastic device powered by a vibrating motor and an ice pack. Buzzy is attached to the skin using a tourniquet 3 to 5 cm above the injection site just before the injection. Vibrations started 30 seconds before the procedure and continued until it was completed. The device was cleaned with 70% alcohol before use on another child.

Other: Buzzy® Group

Interventions

ShotBlocker® OTHER

All children underwent a standard procedure. The standard procedure involved taking the child into the vaccination room, providing information about the vaccination procedure, introducing the researcher, and obtaining consent. The STAI-S was completed immediately before the vaccination. Children were assigned to groups as specified in the randomization procedure. The vaccination of children was performed by an experienced nurse working in the unit where the study was conducted to control for practitioner-related factors.It is positioned onto the skin before an injection is made. After positioning the ShotBlocker® and ensuring that the contacts were in contact with the children's skin, the injection was made through the central hole by the nurse. The ShotBlocker® was cleaned with 70% alcohol before use on another child.

ShotBlocker® Group

Buzzy® Group OTHER

All children underwent a standard procedure. The standard procedure involved taking the child into the vaccination room, providing information about the vaccination procedure, introducing the researcher, and obtaining consent. The STAI-S was completed immediately before the vaccination. Children were assigned to groups as specified in the randomization procedure. The vaccination of children was performed by an experienced nurse working in the unit where the study was conducted to control for practitioner-related factors. Vibrations started 30 seconds before the procedure and continued until it was completed. The device was cleaned with 70% alcohol before use on another child

Buzzy® Group

Eligibility Criteria

• Age: 13 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years
• being conscious (with the ability to communicate)

You may not qualify if:

• having a physical and psychological condition
• taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
• having chronic or life-threatening disease
• refusing the shotblocker or buzzy intervention during vaccine injection.

Sponsors & Collaborators

• Mehmet Akif Ersoy University: lead

Study Sites (1)

Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Hatice Erdem Önder

  Mehmet Akif Ersoy University

  STUDY CHAIR

• Dilek Sari

  Ege University

  STUDY DIRECTOR

• Nihal Taşkiran

  Aydin Adnan Menderes University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dr.

Model Details: The participants were randomly assigned to ShotBlocker®, Buzzy®, and control groups.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: November 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)