The Impact of Helfer Skin Tap and ShotBlocker Techniques on Emotional Responses to Intramuscular Injections in Children

Summary

Study Aim: This study aims to determine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional indicators, and physiological parameters during intramuscular (IM) drug administration in children aged 7-12 years.

Study Design This research is designed as a randomized controlled experimental study.

Study Setting and Characteristics The study will be conducted at the Pediatric Emergency Clinic of Fırat University Hospital. The Pediatric Emergency Clinic consists of two observation rooms with a total of 12 beds, where children's medication administration and follow-ups are carried out.

The study population comprises children aged 7-12 years who received Vastus Lateralis IM drug administration (ZOFER® 8mg/4ml Injectable Solution - Ondansetron Hydrochloride Dihydrate) at the Pediatric Emergency Clinic of Fırat University Hospital and met the inclusion criteria during the specified study period.

For sample size estimation, the pain scores from the study by Sivri, Bilgen, and Balcı (2019) were considered. Based on their findings (d = 0.82; α = 0.05), it was determined that a sample size of 40 children per group (HST, ShotBlocker, and control) would be sufficient. Considering potential dropouts, the sample size was increased by 10%, and the study was planned to include a total of 132 children who met the inclusion criteria and provided informed consent along with their parents.

Conditions

• Children

Interventions

OTHER

Helfer skin tap technique

In the unit where the study was conducted, IM drug administration is performed through the Vastus Lateralis muscle in children aged 7-12 years and with BMI in the appropriate percentile according to age. No anaesthetic etc. application is performed. In order to create similar conditions in the study, children who are requested to be administered IM (ZOFER® 8mg / 4ml Injectable Solution-Ondansetron hydrochloride dihydrate into the Vastus Lateralis) will be included in the study. IM injection will be performed by the same investigator into the Vastus Lateralis muscle of the patient. A 16mm or 22mm, 22-25gauge sterile disposable sterile disposable needle will be used in all patients for injection administration. the procedure will be performed with helfer skin tap technique. Forms will be applied to the children by the researcher before and after IM injection.

OTHER

Shotblocker technique

In the unit where the study was conducted, IM drug administration is performed through the Vastus Lateralis muscle in children aged 7-12 years and with BMI in the appropriate percentile according to age. No anaesthetic etc. application is performed. In order to create similar conditions in the study, children who are requested to be administered IM (ZOFER® 8mg / 4ml Injectable Solution-Ondansetron hydrochloride dihydrate into the Vastus Lateralis) will be included in the study. IM injection will be performed by the same investigator into the Vastus Lateralis muscle of the patient. A 16mm or 22mm, 22-25Gauge sterile disposable sterile disposable needle will be used in all patients. The procedure will be performed using Shotblocker method. Forms will be applied to the children by the investigator before and after IM injection.

Sponsors & Collaborators

• Inonu University

  lead OTHER

Principal Investigators

• Seher Cevik Aktura · Inonu University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-02

Primary Completion

2024-11-14

Completion

2025-01-15

Countries

• Turkey (Türkiye)

Study Locations