The Effect of the Helper Skin Tap Technique and Buzzy® During Vaccination

March 13, 2024 updated by: Duygu Sonmez Duzkaya, Tarsus University

The Effect of the Helper Skin Tap Technique and Buzzy® Application on the Level of Pain and Anxiety Experienced by Children During Vaccination

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mersin, Turkey, 33400
        • Tarsus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Helper Skin Tap Technique Group
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. Slow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn.
Other: Helfer Skin Tap
Slow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn.
Experimental: Buzzy Group
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 ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds.
Other: Buzzy
The ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds.
No Intervention: Control Group
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. MMR vaccine injection was routinely administered in the area corresponding to the left deltoid muscle without any intervention or application to the injection site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Fear Scale
Time Frame: 1 day
The Child Fear Scale is used to assess the anxiety levels of children with five face shapes scored between 0-4: 0 = no anxiety, and 4 = severe anxiety. The scale can be evaluated by both the child and the researcher before, during, and after the intervention.
1 day
Child Information Form
Time Frame: 1 day
The information form has been prepared by reviewing the literature on the subject (Canbulat and Bal 2015; Canbulat et al 2014) and includes the child's age, gender, height, weight, presence of other children in the family, physiological parameters before and after vaccination injection, Wong-Baker pain score, and Fear score evaluated by the nurse, parent, and child before and after the vaccination injection. There are a total of 5 questions in the data collection form.
1 day
Wong-Baker Scale (Pain Facial Expression Scale)
Time Frame: 1 day
The Wong-Baker scale consists of faces representing increasing levels of pain from zero to five, moving from left to right. The face on the far left has a smiling expression, indicating a pain-free condition, while the face on the far right has a crying expression, representing the most severe pain. Each facial expression is accompanied by a brief description explaining the pain intensity: 0 - no pain, 1 - mild pain, 2 - a bit more pain, 3 - even more pain, 4 - quite a lot of pain, 5 - the most severe pain.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

October 2, 2023

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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