Clinical trial NCT06851182: The Impact of Helfer Skin Tap and ShotBlocker Techniques on Emotional Responses to Intramuscular Injections in Children
Official title: Comparison of Two Different Skin Stimulation Techniques on Intramuscular Injection Pain and Emotional Responses in Children: Helfer Skin Tap Technique and ShotBlocker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Keywords: Intramuscular Injection Pain
Emotional Responses in Children
Helfer Skin Tap Technique
ShotBlocker
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 132
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This randomized controlled experimental study aimed to examine the effects of the Helfer Skin Tap Technique (HST) and ShotBlocker application on pain, emotional responses, and physiological parameters in children aged 7-12 years undergoing intramuscular (IM) drug administration. The study was conducted at the Pediatric Emergency Clinic of Fırat University Hospital between October 1, 2024, and January 31, 2025. The clinic consisted of two observation rooms with 12 beds, where children's medication administration and follow-ups were carried out. The study population included children aged 7-12 years who received Vastus Lateralis IM drug administration (ZOFER® 8mg/4ml Injectable Solution - Ondansetron Hydrochloride Dihydrate) and met the inclusion criteria.

The sample size was determined based on the pain scores from the study by Sivri, Bilgen, and Balcı (2019), with an effect size of d = 0.82 and α = 0.05, indicating that a sample of 40 children per group (HST, ShotBlocker, and control) was sufficient. To account for potential dropouts, the sample size was increased by 10%, resulting in a total of 132 children who met the inclusion criteria and provided informed consent along with their parents.

Participants' pre-test data were collected by the researcher before randomization. To ensure homogeneity, children were stratified based on age, gender, quality of life, and fatigue levels before being assigned to groups using a simple random sampling method. Blinding among researchers was not feasible, and patients in different groups were assigned to different hospital beds. To minimize selection bias, simple randomization was applied. The study protocol was registered in the ClinicalTrials.gov database, supported by the U.S. National Library of Medicine and the National Institutes of Health (NIH). Patients were unaware of their assigned groups (experimental or control).

Data Collection and Measurement Tools

Data were collected using the following tools:

Descriptive Characteristics Form (including age, gender, diagnosis, and history of IM injections).

Physiological Parameters Observation Form, which recorded pre- and post-injection heart rate, respiratory rate, and oxygen saturation using a pulse oximeter.

Faces Pain Scale-Revised (FPS-R), developed by Hicks et al. (2001), a self-reported scale ranging from 0 to 10, with higher scores indicating more severe pain.

Children's Emotional Indicator Scale (CEIS), developed by Li \& Lopez (2005), measuring observable emotional behaviors in five categories (facial expression, vocalization, activity, interaction, and cooperation level), with scores ranging from 5 to 25, where higher scores indicated increased distress. The scale had a Cronbach's alpha value of 0.92 in its original version, while its Turkish adaptation in this study achieved 0.94.

Study Implementation IM injections were administered to children aged 7-12 years with a BMI percentile appropriate for their age. The injections were performed on the Vastus Lateralis muscle using a 16mm or 22mm, 22-25 gauge single-use sterile needle by the same researcher under standard conditions. No local anesthetic or analgesic was applied before the procedure. The research forms were completed before and after the injection by the researcher.

This study provided valuable insights into the effects of skin stimulation techniques on pain perception, emotional distress, and physiological responses in pediatric IM injections, contributing to improved pain management strategies in clinical practice.

Eligibility criteria: Inclusion Criteria:

* - 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.

Exclusion Criteria:

* - 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.

Primary outcomes:
measure: Children's Emotional Indicator Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu university
Study officials:
affiliation: Inonu University
name: Seher Cevik Aktura
role: PRINCIPAL_INVESTIGATOR
References: