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

NCT06397352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-05-02

No results posted yet for this study

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

Interventions

OTHER

ShotBlocker®

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.

OTHER

Buzzy® Group

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

Sponsors & Collaborators

  • Mehmet Akif Ersoy University

    lead OTHER

Principal Investigators

  • Hatice Erdem Önder · Mehmet Akif Ersoy University

  • Dilek Sari · Ege University

  • Nihal Taşkiran · Aydin Adnan Menderes University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-08-01
Completion
2023-09-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397352 on ClinicalTrials.gov