Clinical trial NCT06397352: Effects of Buzzy® and ShotBlocker® on Pain, Anxiety and Satisfaction During the Administration of Vaccine
Official title: Effects of Buzzy® and ShotBlocker® on Pain, Anxiety and Satisfaction During the Administration of Tetanus-Diphtheria Vaccine to School-Aged Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Satisfaction
Keywords: Buzzy
Shotblocker
pain
anxiety
satisfaction
vaccine
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 138
Sex: ALL
Minimum age (years): 13
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were randomly assigned to ShotBlocker®, Buzzy®, and control groups.
Primary purpose: OTHER

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.

Detailed description: This research aims to determine effects of Buzzy® and ShotBlocker® on pain and anxiety during the administration of tetanus-diphtheria vaccine to school-aged children.

The following hypotheses were determined for the present study. Hypothesis 1. ShotBlocker® is effective in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.

Hypothesis 2. Buzzy® is effective in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.

Hypothesis 3. Buzzy® is more effective than ShotBlocker in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.

This prospective, randomised controlled study was conducted in one family health centers of Manisa, Turkey, between November 2021- August 2023. A parallel trial design was used describing, shotblocker, buzzy, and control group as the third arm. This study was guided by the Consolidated Standards of Reporting Trials (CONSORT) checklist. This study was conducted in one family health centers with the same nurse. Children aged 13 years who underwent tetanus- Diftevaccine injection were eligible to participate in the study. The inclusion criteria were being 13 years and being conscious (with the ability to communicate). The exclusion criteria were having a physical and psychological condition; taking any analgesics, sedatives, or anticonvulsants in the past 24 hours; having chronic or life-threatening disease; and refusing the shotblocker or buzzy intervention during vaccine injection. The sample size for the research was determined using G\*power 3.0.8 software, and power analysis was conducted. With a 5% error rate, 80% power, and a medium effect size of 0.25 for the 3 groups with 2 repeated factors, it was calculated that 46 children should be taken for each group (Ellis, 2010). The study sample composed of 138 children. Childrens presenting for tetanus vaccine injection and fulfilling the inclusion criteria were assigned into three groups: Shotblocker®, Buzzy® and control groups (exposed to the conventional injection technique). So that effects of gender could be controlled, the childrens were first categorized according to their genders and then assigned into the three groups through block randomization. To ensure randomization and minimize all possible negative effects, the words shotblocker, buzzy and control, representing the three groups, were written on papers of the same color and shape and placed in a pink and a blue box. During the routine vaccination of children, which group would be included was determined by a lottery drawn by the child, just before the procedure started. The girls were asked to draw a paper from the pink box and boys from the blue box. This allowed keeping the effect of gender under control. Each group included 46 children, of whom 23 were female and 23 were male.

Eligibility criteria: Inclusion Criteria:

* 13 years
* being conscious (with the ability to communicate)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Visual Analog Scale were completed immediately after the vaccination.
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: State-Trait Anxiety Inventory (STAI) were completed immediately after the vaccination
measure: Satisfaction level
timeFrame: Satisfaction were completed immediately after the vaccination
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Mehmet Akif Ersoy University
Study officials:
affiliation: Mehmet Akif Ersoy University
name: Hatice Erdem Önder
role: STUDY_CHAIR
affiliation: Ege University
name: Dilek Sari
role: STUDY_DIRECTOR
affiliation: Aydin Adnan Menderes University
name: Nihal Taşkiran
role: STUDY_CHAIR
References: