search
Back to results

The Effect of Helfer Skin Tap Technique on Pain, Fear, and Anxiety in Children Undergoing Intramuscular Injection

Primary Purpose

Pain, Acute, Fear Anxiety, Child, Only

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Helfer Skin Tap Technique
Sponsored by
Aylin Kurt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain, Acute

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The child is between the ages of 4-10
  • The child's application to the Pediatric Emergency Unit
  • Parent and child agreeing to participate in the project
  • Absence of speech and visual impairment of the child and his parents

Exclusion Criteria:

  • The child is not between the ages of 4-10
  • The child's application to another department except for the Pediatric Emergency Unit
  • Parent and child not agreeing to participate in the project
  • Having speech and visual impairment of the child and his parents

Sites / Locations

  • Bartın University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

No intervention

Arm Description

All registered participants in the intervention group, will receive the intramuscular injection with Helfer Skin Tap Technique.

All registered participants in the intervention group, will receive the intramuscular injection with Routine Technique. Routine Technique involved inserting the injection intra muscularly at 90 degree angle into Dorso gluteal muscles without tapping after cleaning with alcohol swab.

Outcomes

Primary Outcome Measures

Difference of the mean score of the "Wong Baker FACES Pain Rating Scale" between intervention and control groups
"Wong Baker FACES Pain Rating Scale" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will pain about intramuscular injection in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher pain. This scale will also be completed at during and 5. minutes after the intervention. The quantitative data will be used to measure a change in the children's pain level before, and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "Wong-Baker FACES Pain Rating Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Difference between the mean score of the "Child Fear Scale" between intervention and control groups
"The Child Fear Scale" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will fear about the intramuscular injection in children. A minimum of 0 points and a maximum of 20 points can be obtained from the scale. The higher scores mean the higher fear. This scale will also be completed at during and 5 minutes after the intervention. The quantitative data will be used to measure a change in the children's fear level before, and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "The Child Fear Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Difference between the mean score of the "Child Anxiety Meter-State" between intervention and control groups
"The Child Anxiety Meter-State" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will anxiety about the intramuscular injection in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher anxiety. This scale will also be completed at during and 5 minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety level before and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "The Child Anxiety Meter-State" between intervention and control groups will be examined. The Child Anxiety Meter-State total score mean of the children in the intervention group will be lower after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.

Secondary Outcome Measures

Change of the mean scores obtained by the children in the intervention group from the "Wong Baker FACES Pain Rating Scale" before and after the intervention.
"The Wong Baker FACES Pain Rating Scale" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address pain about the inhaler treatment with a nebulizer in children.A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher pain. This scale will also be completed at the intervention during and during and 5 minutes after the intervention. The quantitative data will be used to measure the change in the children's pain before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.
"The Child Fear Scale" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address fear about the inhaler treatment with a nebulizer in children. A minimum of 0 points and a maximum of 20 points can be obtained from the scale. The higher scores mean the higher fear. This scale will also be completed at the intervention during and 1. minutes after the intervention. The quantitative data will be used to measure the change in the children's fear before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Change of the mean scores obtained by the children in the intervention group from the " Child Anxiety Meter-State " before and after the intervention.
"The Child Anxiety Meter-State" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address anxiety about the inhaler treatment with a nebulizer in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher anxiety. This scale will also be completed at the intervention during and 1. minutes after the intervention. The quantitative data will be used to measure the change in the children's anxiety before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.

Full Information

First Posted
January 28, 2022
Last Updated
May 10, 2023
Sponsor
Aylin Kurt
search

1. Study Identification

Unique Protocol Identification Number
NCT05250804
Brief Title
The Effect of Helfer Skin Tap Technique on Pain, Fear, and Anxiety in Children Undergoing Intramuscular Injection
Official Title
The Effect of Helfer Skin Tap Technique on Pain, Fear, and Anxiety in Children Undergoing Intramuscular Injection: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aylin Kurt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to examine the effect of the Helfer Skin Tapping technique on pain, fear, and anxiety in children who received intramuscular injections. The research hypotheses are as follows: H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Wong-Baker FACES Pain Rating Scale", "Child Fear Scale", and "Child Anxiety Scale-State" during and after the Helfer Skin Tapping technique. H1: During and after the Helfer Skin Tapping technique, the mean score of the "Wong-Baker FACES Pain Rating Scale", "Child Fear Scale", and "Child Anxiety Scale-State" is significantly lower in the intervention group compared to the control group.
Detailed Description
In this study, there will be two groups as the intervention (who will receive an intramuscular injection with the Helfer Skin Tapping technique) and the control group (who will receive an intramuscular injection with Routine Technique). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 32 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The intramuscular injection will be applied to both the intervention and control groups. The children in the intervention group will receive an intramuscular injection with the Helfer Skin Tapping technique and the control group will receive an intramuscular injection with Routine Technique in the pediatric emergency service. A researcher and a nurse were employed for the intramuscular injection both for the intervention and control groups. A pediatric nurse performed the intramuscular injection for all children and the other researcher helped the children to assess their pain, fear, and anxiety level. Pain, fear, and anxiety in children were evaluated by the children and their parents before, during, 5 minute after the procedure. The intramuscular injection will be performed by the same nurse both in the intervention and control groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Fear Anxiety, Child, Only, Injection Site

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
All registered participants in the intervention group, will receive the intramuscular injection with Helfer Skin Tap Technique.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
All registered participants in the intervention group, will receive the intramuscular injection with Routine Technique. Routine Technique involved inserting the injection intra muscularly at 90 degree angle into Dorso gluteal muscles without tapping after cleaning with alcohol swab.
Intervention Type
Other
Intervention Name(s)
Helfer Skin Tap Technique
Intervention Description
Helfer Skin Tap Technique is a technique in which the researcher taps the Dorso gluteal muscle by counting 1-15 with the palmar aspect of fingers (non-dominant hand) in rhythmic manner before inserting the injection intra muscularly at 90 degree and remove the needle quickly again by tapping and counting 1-3.
Primary Outcome Measure Information:
Title
Difference of the mean score of the "Wong Baker FACES Pain Rating Scale" between intervention and control groups
Description
"Wong Baker FACES Pain Rating Scale" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will pain about intramuscular injection in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher pain. This scale will also be completed at during and 5. minutes after the intervention. The quantitative data will be used to measure a change in the children's pain level before, and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "Wong-Baker FACES Pain Rating Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Time Frame
12 months
Title
Difference between the mean score of the "Child Fear Scale" between intervention and control groups
Description
"The Child Fear Scale" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will fear about the intramuscular injection in children. A minimum of 0 points and a maximum of 20 points can be obtained from the scale. The higher scores mean the higher fear. This scale will also be completed at during and 5 minutes after the intervention. The quantitative data will be used to measure a change in the children's fear level before, and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "The Child Fear Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Time Frame
12 months
Title
Difference between the mean score of the "Child Anxiety Meter-State" between intervention and control groups
Description
"The Child Anxiety Meter-State" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will anxiety about the intramuscular injection in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher anxiety. This scale will also be completed at during and 5 minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety level before and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "The Child Anxiety Meter-State" between intervention and control groups will be examined. The Child Anxiety Meter-State total score mean of the children in the intervention group will be lower after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of the mean scores obtained by the children in the intervention group from the "Wong Baker FACES Pain Rating Scale" before and after the intervention.
Description
"The Wong Baker FACES Pain Rating Scale" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address pain about the inhaler treatment with a nebulizer in children.A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher pain. This scale will also be completed at the intervention during and during and 5 minutes after the intervention. The quantitative data will be used to measure the change in the children's pain before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Time Frame
12 months
Title
Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.
Description
"The Child Fear Scale" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address fear about the inhaler treatment with a nebulizer in children. A minimum of 0 points and a maximum of 20 points can be obtained from the scale. The higher scores mean the higher fear. This scale will also be completed at the intervention during and 1. minutes after the intervention. The quantitative data will be used to measure the change in the children's fear before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Time Frame
12 months
Title
Change of the mean scores obtained by the children in the intervention group from the " Child Anxiety Meter-State " before and after the intervention.
Description
"The Child Anxiety Meter-State" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address anxiety about the inhaler treatment with a nebulizer in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher anxiety. This scale will also be completed at the intervention during and 1. minutes after the intervention. The quantitative data will be used to measure the change in the children's anxiety before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The child is between the ages of 4-10 The child's application to the Pediatric Emergency Unit Parent and child agreeing to participate in the project Absence of speech and visual impairment of the child and his parents Exclusion Criteria: The child is not between the ages of 4-10 The child's application to another department except for the Pediatric Emergency Unit Parent and child not agreeing to participate in the project Having speech and visual impairment of the child and his parents
Facility Information:
Facility Name
Bartın University
City
Bartın
State/Province
Province
ZIP/Postal Code
74100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
12 months

Learn more about this trial

The Effect of Helfer Skin Tap Technique on Pain, Fear, and Anxiety in Children Undergoing Intramuscular Injection

We'll reach out to this number within 24 hrs