ShotBloker and Helfer Skin Tap Technique During Intramuscular Injection in Children

November 23, 2023 updated by: Atiye Karakul, Tarsus University

The Effect of ShotBloker and Helfer Skin Tap Technique on Pain and Fear During Intramuscular Injection in Children Aged 6-12 in the Pediatric Emergency Unit

To examine the effect of the Helfer skin tap technique and ShotBloker application on pain and fear experienced during intramuscular injection in children aged 6-12 in the pediatric emergency unit. It was planned as a randomized controlled experimental study to determine its effect on fear. The population of the study will be children aged 6-12 years who applied to the Tarsus State Hospital, and Pediatric Emergency Clinic and the sample will be 177 children who will undergo intramuscular intervention and meet the criteria for inclusion in the study. In data collection; Data collection form, Wong-Baker Scale, and Child fear scale will be used. In order to examine the mean scores of pain and fear according to intramuscular administration techniques in children, appropriate tests will be used by making an analysis of conformity to normal distribution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain is an experience of complex perceptions that overwhelms the patient, distorts their behavior and thoughts, prompts them to perform activities that require immediate attention and aim to stop the pain, and causes behavioral reactions and automatic changes.

To examine the effect of the Helfer skin tap technique and ShotBloker application on pain and fear experienced during intramuscular injection in children aged 6-12 in the pediatric emergency unit.

Type of Study: It was planned as a randomized controlled experimental study to determine the effect of Helfer skin tap technique and Shot Blocker application on pain and fear experienced during intramuscular injection in children aged 6-12 years who applied to the pediatric emergency clinic.

Research Population and Sample Selection The population of the study will be children aged 6-12 years who applied to the Tarsus State Hospital, Pediatric Emergency Clinic, and the sample will be 177 children who will undergo intramuscular intervention, meeting the criteria for inclusion in the research. According to the results of the G-power analysis for the sample size, in accordance with the literature of Canbulat and Bal (2015), Canbulat et al (2014) and Mutlu (2012) to find a medium power effect size difference of 0.25 between the groups, type I error 0.05, power of the test. While 0.80 (α= 0.05, β= 0.20), the minimal sample size was 177 (n=59 for each group).

Data collection Stages of Research Stage 1: A pilot study will be conducted with 20 children in order to evaluate the appropriateness of the forms and scales used before the research.

Stage 2: The purpose of the research and how to record the data will be explained to the nurse who will administer the intramuscular injection procedure using the ventrogluoteal region and to the nurse who will observe the child's pain and fear during the procedure. The children in the sample group and their parents will be informed about the path followed in practice and the research, and their verbal and written consent will be obtained.

Stage 3: The patients who meet the sample selection criteria will be randomly and equally distributed into 3 groups through a program in the computer environment, and randomization will be provided.

(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html) (1st experimental group Helfer skin tap technique suitable group, 2nd experimental group Shot Blocker group, 3rd group control group) Children in each group will be provided with their parents.

Stage 4: The nurse observing the children in all groups before the procedure will fill in the demographic data form, measure the child's pulse, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent.

Stage 5: Intramuscular injection will be given to the ventrogluoteal region by following the procedure steps for the children in all groups. The intramuscular injection procedure will be performed by the same nurse. During the procedure, the child's pain and fear will be observed by the observing nurse and recorded in the observation form.

At this stage;

  • First Experimental group; During the intramuscular injection to be applied to the ventrogluoteal region, the level of pain and fear will be examined using the Helfer skin tap technique.
  • Second Experiment group; During the intramuscular injection to be applied to the ventrogluoteal region, the level of pain and fear will be examined by using Shot Blocker.
  • To the control group; The level of pain and fear will be examined during intramuscular injection into the ventrogluotealregion without any intervention.

Stage 6: 5 minutes after the procedure, the pain and fear level of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse.

Stage 7: The analysis and reporting of the obtained data will be done.

Study Type

Interventional

Enrollment (Actual)

177

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
        • Tarsus State Hospital

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To be 6-12 years old,
  • Volunteering to participate in the research,
  • Not having a chronic disease, not having a mental or neurological disability,
  • Being able to communicate verbally,
  • Not taking any medication that has an analgesic effect at least 6 hours before applying to the emergency room.
  • Not have a life-threatening (sepsis, shock, respiratory/cardiogenic arrest, etc.) disease

Exclusion Criteria:

  • Not to be between the ages of 6-12,
  • Not volunteering to participate in the research,
  • Having a chronic disease, mental or neurological disability,
  • Taking any analgesic medication at least 6 hours before applying to the emergency room
  • Having a life-threatening (sepsis, shock, respiratory/cardiogenic arrest, etc.) disease

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: Helfer Skin Tap

Helfer Skin Tap (rhythmic tapping of the skin at the injection site to relax the muscles during injection) is an effective method in reducing pain in intramuscular applications in studies performed with the injection technique.

Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent.

During the intramuscular injection to be applied to the ventrogluteal region, the level of pain and fear will be examined using the Helfer skin tap technique.

5 minutes after the injection, the pain and fear level of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse.
Other: Helfer skin tap technique
Using the Helfer skin tap technique during intramuscular injection to the ventrogluteal region.
Experimental: Shotblocker

Shotblocker is a flat, horseshoe-shaped device with short, non-sharp 2 mm thick blunt protrusions that connect with the skin, and a hole in the middle to expose the injection site used to reduce pain during subcutaneous or intramuscular injection applications.

Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent.

During the intramuscular injection to be applied to the ventrogluteal region, the level of pain and fear will be examined by using Shot Blocker.

5 minutes after the injection, the pain and fear levels of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse.
Device: Shot Blocker
Shot Blocker will be used during intramuscular injection to be applied to the ventrogluteal region.
No Intervention: control group

Before the injection, the observer nurse will fill in the demographic data form, measure the child's heart rate, blood pressure and SpO2 values, and apply the pain and fear assessment scale. In addition, the pain and fear scale will be evaluated by the child and the parent.

The level of pain and fear will be examined during intramuscular injection into the ventrogluteal region without any intervention.

5 minutes after the injection, the pain and fear level of the children in all groups will be re-evaluated by the child, the mother and the observing nurse. After the procedure, pulse, blood pressure and SpO2 values will be measured and recorded by the observing nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wong-Baker Scale score
Time Frame: 1 day

Wong-Baker Scale (Pain Face Rating Scale): In the Wong-Baker scale, there are faces representing increasing pain severity from left to right, ranging from zero to five. The leftmost face has a smiling expression, indicating a pain-free state, while the right-most face has a crying expression, corresponding to the most severe pain. Below each facial expression is a short description describing the severity of pain: 0 - no pain, 1- a little pain, 2- a little more pain, 3- even more pain, 4- a lot of pain, 5- the most severe pain.

Before, during, and 5 minutes after the injection, the pain level of the children in all groups will be re-evaluated.
1 day
Child Fear Scale score
Time Frame: 1 day

Child Fear Scale: The Child Fear Scale is a scale used to assess the anxiety level of children with 5 face shapes scored between 0-4. 0 = no anxiety, 4 = severe anxiety.

Before, during, and 5 minutes after the injection, the fear level of the children in all groups will be re-evaluated.
1 day
mean arterial pressure
Time Frame: 1 day
The mean arterial pressureof the child was evaluated and recorded before during, and 5 minutes after the injection
1 day
heart rate
Time Frame: 1 day
The heart rate of the child was evaluated and recorded before during, and 5 minutes after the injection
1 day
saturation
Time Frame: 1 day
The saturation of the child was evaluated and recorded before during, and 5 minutes after the injection
1 day

Collaborators and Investigators

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

Sponsor

Tarsus University

Investigators

  • Principal Investigator: Duygu Sönmez Düzkaya, Tarsus University
  • Principal Investigator: Senem Andı, Tarsus Univesity

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)

April 10, 2022

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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