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Completed

NCT Number: NCT05563233

ShotBloker and Helfer Skin Tap Technique During Intramuscular Injection in Children

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus State Hospital

Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Helfer Skin Tap Technique

Other

Using the Helfer skin tap technique during intramuscular injection to the ventrogluteal region.

Shot Blocker

Device

Shot Blocker will be used during intramuscular injection to be applied to the ventrogluteal region.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. heart rate

    Time frame: 1 day

    The heart rate of the child was evaluated and recorded before during, and 5 minutes after the injection

  5. saturation

    Time frame: 1 day

    The saturation of the child was evaluated and recorded before during, and 5 minutes after the injection

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2022
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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