Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397352
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Brief Title:
Effects of Buzzy and ShotBlocker on Pain Anxiety and Satisfaction During the Administration of Vaccine
Sponsor:
Mehmet Akif Ersoy University
Organization:
Mehmet Akif Ersoy University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Gpower 308 software and power analysis was conducted With a 5 error rate 80 power and a medium effect size of 025 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
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 Gpower 308 software and power analysis was conducted With a 5 error rate 80 power and a medium effect size of 025 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None