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

NCT05250804 | Completed

• 1 other identifier: 2021-SBB-0513
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Fear Anxiety; Child, Only; Injection Site

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (3)

• 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.

  12 months

• Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.

  12 months

• Change of the mean scores obtained by the children in the intervention group from the " Child Anxiety Meter-State " before and after the intervention.

  12 months

Study Arms (2)

Experimental

EXPERIMENTAL

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

Other: Helfer Skin Tap Technique

No intervention

NO INTERVENTION

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.

Interventions

Helfer Skin Tap Technique OTHER

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.

Experimental

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aylin Kurt: lead

Study Sites (1)

Bartın University

Bartın, Province, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 22, 2022
• Study Start: February 28, 2022
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months

Locations

TU (1)