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

NCT06851182 | Completed

• 1 other identifier: Seher C Aktura
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intramuscular Injection Pain; Emotional Responses in Children; Helfer Skin Tap Technique; ShotBlocker

Outcome Measures

Primary Outcomes (1)

• Children's Emotional Indicator Scale

  The Children's Emotional Indicator Scale (CEIS) was developed by Li and Lopez (2005) to provide a simple, objective and consistent method for nurses to identify children's emotional behaviors during stressful medical procedures. The CSA consists of five categories of observable emotional behaviors (Facial expression, Vocalization, Activity, Interaction and Level of cooperation). Each category has a value between 1-5. The total score that can be obtained from the scale varies between 5-25. The higher the scores obtained from the scale, the higher the negative emotional indicators.

  1 month

Study Arms (3)

Helfer Skin Tap Group

EXPERIMENTAL

Helfer Skin Tap Group: The patient will be positioned in the most comfortable way possible. For the injection in the Vastus Lateralis muscle, the patient will be positioned appropriately lying down. After identifying the injection site, the skin will be gently tapped with the palmar surface of the dominant hand's fingers for approximately 5 seconds (about 15 strokes) to relax the muscles. After cleaning the skin with alcohol, the cap of the syringe in the dominant hand will be removed. The non-dominant hand's thumb and index finger will form a large V, and gentle taps will be applied to the skin again. The entire palm of the hand will be used to deliver three firm strokes to the muscle. The strokes (not slaps) should be firm to stimulate the large muscle fibers. After counting to three, the syringe will be inserted into the muscle at a 90° angle simultaneously.

Other: Helfer skin tap technique

Shotblocker Group

EXPERIMENTAL

1. Ensure that the patient takes the most comfortable position possible. For injection into the Vastus Lateralis muscle, the patient will be made to lie in the appropriate position. 2. While removing the cap of the injector needle and holding it between the index and thumb of the active hand, the Shotblocker will be placed appropriately on the injection site with the passive hand, light pressure will be applied. 3. The syringe will be inserted into the tissue smoothly at an angle of 90°. The needle will be prevented from moving in the tissue by holding the ajutage with the thumb and index finger of the passive hand. While holding the Shotblocker with the passive hand, the needle will be prevented from moving in the tissue by holding the ajutage with the thumb and index finger of the passive hand. Aspiration will be performed by pulling the piston back with the active hand. 4. The drug will be injected into the muscle at a rate of 1ml/10sec.

Other: Shotblocker technique

control

NO INTERVENTION

Children included in the control group will be administered IM Zofer drug (the drug will be injected into the muscle at a rate of 1ml/10 sec) with routine standard care of the ward.

Interventions

Helfer skin tap technique OTHER

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.

Also known as: Helfer skin tap

Helfer Skin Tap Group

Shotblocker technique OTHER

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.

Also known as: Shotblocker

Shotblocker Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 7 to 12 years old,
• BMI level in the appropriate range according to age,
• IM drug administered to the Vastus Lateralis muscle,
• No disease that causes chronic pain,
• Not taking any analgesic medication in the last 8 hours before the procedure,
• No mental or neurological disability,
• No visual or auditory problems preventing the application of the scales,
• Speaks and understands Turkish,
• Children whose parents and themselves agreed to participate in the study were included in the study.

You may not qualify if:

• \- BMI level is not in the appropriate range according to age,
• Forms with incomplete or incorrect answers,
• Children who did not volunteer to participate in the study were excluded from the study.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu university

Malatya, 44100, Turkey (Türkiye)

Location

Study Officials

• Seher Cevik Aktura

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 28, 2025
• Study Start: September 2, 2024
• Primary Completion: November 14, 2024
• Study Completion: January 15, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)