Clinical trial NCT06312228: The Effect of the Helper Skin Tap Technique and Buzzy® During Vaccination
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Keywords: pain
fear
Buzzy
Helfer skin tap teknik
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 96
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 children.Method: 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. Children's 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 G\*Power 3.1 programme. With a Type I error of 0.05 and a test power of 0.80 (α= 0.05, 1-β= 0.80), 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 Health's 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 parent's lap (on the knee) and the holding position was adjusted. The child's legs were placed between the parent's 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. 2.15.3 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 Fisher's exact test were used to compare qualitative variables. Statistical significance was accepted as p\<0.05.

Eligibility criteria: Inclusion Criteria:

* The child being at least 4 years old,
* The administration of the DTP vaccine,

  * Being at an appropriate weight for their age,
  * The child not having received any analgesic medication during the day,
  * The willingness of the parent to participate in the research

Exclusion Criteria:

- Having a neurological illness,

* Having a chronic illness,
* Having an allergy (egg allergy),
* Having a body temperature above 37.5 degrees Celsius

Primary outcomes:
measure: Child Information Form
timeFrame: 1 day
measure: Wong-Baker Scale (Pain Facial Expression Scale)
timeFrame: 1 day
measure: Child Fear Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus University
Study officials:
References:
citation: Ayinde O, Hayward RS, Ross JDC. The effect of intramuscular injection technique on injection associated pain; a systematic review and meta-analysis. PLoS One. 2021 May 3;16(5):e0250883. doi: 10.1371/journal.pone.0250883. eCollection 2021.
citation: Therese, A. M., & Devi, S. (2014). Effectiveness of Helfer skin tap technique and routine technique on pain reduction among patients receiving intramuscular injection at Government General Hospital, Puducherry. Int J Sci Res, 3(10).
citation: Jose, R. M., Sulochana, B., & Shetty, S. (2012). Effectiveness of Skin Tap Technique in Reducing Pain Response. International Journal of Nursing Education, 4(1).
citation: Mahato, E. (2019). Effectiveness of Helfer's Skin Tap Technique Versus Routine Technique on Pain Reduction among Patient's Receiving Intramuscular Injections. International Journal of Nursing Education, 11(1),41-44.
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citation: Shah V, Taddio A, McMurtry CM, Halperin SA, Noel M, Pillai Riddell R, Chambers CT; HELPinKIDS Team. Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis. Clin J Pain. 2015 Oct;31(10 Suppl):S38-63. doi: 10.1097/AJP.0000000000000281.
citation: Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. The influence of children's pain memories on subsequent pain experience. Pain. 2012 Aug;153(8):1563-1572. doi: 10.1016/j.pain.2012.02.020. Epub 2012 May 3.
citation: Koc T, Gozen D. The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2015 Oct;12(5):289-96. doi: 10.1111/wvn.12099. Epub 2015 Jul 28.