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

NCT ID: NCT05250804

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-07-12

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Helfer Skin Tap Technique

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Helfer Skin Tap Technique

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aylin Kurt

OTHER

Sponsor Role: lead

Responsible Party

Aylin Kurt

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bartın University

Bartın, Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021-SBB-0513

Identifier Type: -

Identifier Source: org_study_id