Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312228
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
The Effect of the Helper Skin Tap Technique and Buzzy During Vaccination
Sponsor:
Tarsus University
Organization:
Tarsus University
Study Overview
Official Title:
The Effect of the Helper Skin Tap Technique and Buzzy Application on the Level of Pain and Anxiety Experienced by Children During Vaccination
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Aim This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy application on the pain level during measles-mumps-rubella-mumps MMR vaccine injection in 4-year-old childrenMethod The study was a randomised controlled experimental study The sample of the study consisted of 96 children buzzy 32 helfer skin tap 32 control 32 who underwent MMR vaccination at Bakırköy Family Health Centre No 9 between May 2023 and October 2023 Data Collection Form Wong-Baker pain scale Fear scale and Buzzy device were used as data collection tools Buzzy and Helfer skin tap technique were applied to the children in the intervention group before and after the vaccine injection while routine vaccine injection was applied to the children in the control group Childrens pain and fear responses were evaluated by the nurse and parents before and after vaccine injection and physiological parameters were evaluated by the nurse before and after vaccine injection
Detailed Description:
This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy application on the pain level during measles-mumps-rubella-mumps MMR vaccine injection in 4-year-old children
Materials and Methods Setting The sample of the study consisted of 96 children buzzy 32 helfer skin tap 32 control 32 who underwent MMR vaccination at Bakırköy Family Health Centre No 9 between May 2023 and October 2023
Sample The population of the study which was planned as a randomised controlled experimental study consisted of 4-year-old children who applied to Bakırköy Family Health Centre FHC No 9 for MMR vaccination According to the power analysis for the sample size in line with the literature Mahato and Thakur 2019 Şıktaş and Uysal 2023 the power of the sample was calculated with the GPower 31 programme With a Type I error of 005 and a test power of 080 α 005 1-β 080 the minimum sample size 30 children in each group was calculated as 90 children Considering the losses that may occur from the sample for any reason during the study period the study was completed with 96 children including 32 children in the study and control groups
Data Collection In the study children who came to the Family Health Centre for MMR vaccination were first evaluated in terms of sampling criteria and infants who did not meet the criteria were excluded from the study The nurses who collected and administered the data are different According to the childhood vaccination calendar of the Ministry of Health MMR quadrivalent mixed vaccine DaBT-IPA diphtheria acellular pertussis tetanus inactive polio are administered at the age of 4 years The infants included in the study were first given MMR vaccine in the left arm and the other vaccine was given in the leg 10 minutes after the end of the administration
Application MMR vaccine was administered according to the vaccine administration technique in the Ministry of Healths Expanded Immunisation Programme 2009 Circular Vaccines are stored in the refrigerator under cold chain conditions between 2 0C - 8 0C Before vaccine injection it was ensured that the vaccination room was well lit and warm and children were in a comfortable environment The children in the Helfer Skin Tap Technique buzzy and control group who met the sampling criteria were first examined by the family physician and the parents of the children who did not have any objection to vaccination were informed about the research and their verbal and written consent was obtained and then the data collection form was filled out Before the vaccine injection body weight height and physiological parameters pulse blood pressure SpO2 body temperature were measured and behavioural pain responses were evaluated by the child nurse and parent using the Wong-Baker pain scale and fear scale The child was first seated on the parents lap on the knee and the holding position was adjusted The childs legs were placed between the parents legs and the arms were wrapped around the parent to hold the child After the vaccine injection pain and fear responses were evaluated by the nurse and parent using the Wong-Baker pain scale and fear scale In addition physiological parameters of the children were also measured and recorded
STATISTICAL ANALYSIS Statistical analyses were performed using R vers 2153 program Minimum maximum mean standard deviation median first quartile third quartile frequency and percentage were used to report the study data The Shapiro-Wilk test and graphical analysis were used to evaluate the compliance of quantitative data with normal distribution A dependent groups t-test was used to compare the values before and after the intervention An independent groups t-test was used to evaluate normally distributed variables between two groups One-way analysis of variance was used in the evaluations of variables with normal distribution between more than two groups The Mann-Whitney U test evaluated variables that did not show normal distribution between the two groups The Kruskal-Wallis test was used in the evaluations of variables that did not show normal distribution between more than two groups Pearson correlation analysis was used to determine the relationship between quantitative variables The Pearson chi-square test Fisher-Freeman-Halton exact test and Fishers exact test were used to compare qualitative variables Statistical significance was accepted as p005
Materials and Methods Setting The sample of the study consisted of 96 children buzzy 32 helfer skin tap 32 control 32 who underwent MMR vaccination at Bakırköy Family Health Centre No 9 between May 2023 and October 2023
Sample The population of the study which was planned as a randomised controlled experimental study consisted of 4-year-old children who applied to Bakırköy Family Health Centre FHC No 9 for MMR vaccination According to the power analysis for the sample size in line with the literature Mahato and Thakur 2019 Şıktaş and Uysal 2023 the power of the sample was calculated with the GPower 31 programme With a Type I error of 005 and a test power of 080 α 005 1-β 080 the minimum sample size 30 children in each group was calculated as 90 children Considering the losses that may occur from the sample for any reason during the study period the study was completed with 96 children including 32 children in the study and control groups
Data Collection In the study children who came to the Family Health Centre for MMR vaccination were first evaluated in terms of sampling criteria and infants who did not meet the criteria were excluded from the study The nurses who collected and administered the data are different According to the childhood vaccination calendar of the Ministry of Health MMR quadrivalent mixed vaccine DaBT-IPA diphtheria acellular pertussis tetanus inactive polio are administered at the age of 4 years The infants included in the study were first given MMR vaccine in the left arm and the other vaccine was given in the leg 10 minutes after the end of the administration
Application MMR vaccine was administered according to the vaccine administration technique in the Ministry of Healths Expanded Immunisation Programme 2009 Circular Vaccines are stored in the refrigerator under cold chain conditions between 2 0C - 8 0C Before vaccine injection it was ensured that the vaccination room was well lit and warm and children were in a comfortable environment The children in the Helfer Skin Tap Technique buzzy and control group who met the sampling criteria were first examined by the family physician and the parents of the children who did not have any objection to vaccination were informed about the research and their verbal and written consent was obtained and then the data collection form was filled out Before the vaccine injection body weight height and physiological parameters pulse blood pressure SpO2 body temperature were measured and behavioural pain responses were evaluated by the child nurse and parent using the Wong-Baker pain scale and fear scale The child was first seated on the parents lap on the knee and the holding position was adjusted The childs legs were placed between the parents legs and the arms were wrapped around the parent to hold the child After the vaccine injection pain and fear responses were evaluated by the nurse and parent using the Wong-Baker pain scale and fear scale In addition physiological parameters of the children were also measured and recorded
STATISTICAL ANALYSIS Statistical analyses were performed using R vers 2153 program Minimum maximum mean standard deviation median first quartile third quartile frequency and percentage were used to report the study data The Shapiro-Wilk test and graphical analysis were used to evaluate the compliance of quantitative data with normal distribution A dependent groups t-test was used to compare the values before and after the intervention An independent groups t-test was used to evaluate normally distributed variables between two groups One-way analysis of variance was used in the evaluations of variables with normal distribution between more than two groups The Mann-Whitney U test evaluated variables that did not show normal distribution between the two groups The Kruskal-Wallis test was used in the evaluations of variables that did not show normal distribution between more than two groups Pearson correlation analysis was used to determine the relationship between quantitative variables The Pearson chi-square test Fisher-Freeman-Halton exact test and Fishers exact test were used to compare qualitative variables Statistical significance was accepted as p005
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