ClinicalTrials.Veeva

Menu

Non-Pharmacological Methods in Reducing Injection Pain (Randomized)

S

Sakarya University

Status

Completed

Conditions

Fear
Preschool Age Children
Injection
Pain

Treatments

Other: ShotBlocker
Other: HSTT
Other: Palm

Study type

Interventional

Funder types

Other

Identifiers

NCT07367659
TiryakiÖ.

Details and patient eligibility

About

In emergency departments, various methods can be used to reduce the pain experienced by children. However, the most important requirement is that the selected method provides rapid and effective results. Accordingly, it is essential that interventions performed in emergency settings are carried out in a way that enables children to experience the least possible pain and anxiety and that the long-term effects of pain are prevented. Recently, the Helfer Skin Tap Technique (HSTT), which is applied to reduce stress and pain, and the palm stimulator, which is held in the palm and has raised projections on its surface to reduce pain perception by facilitating distraction, have attracted attention. ShotBlocker is a noninvasive, U-shaped plastic device with small projections that is used to reduce injection-related pain in children who are sensitive to pain. In addition, a bee-shaped device called Buzzy®, which combines external cold application and vibration, is also widely used. These methods have been proven to be effective in reducing pain in pediatric patients during invasive procedures such as intramuscular injections and intravenous cannulation.

Enrollment

120 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Children aged between 4 and 6 years,
  • An intramuscular (IM) medication order was prescribed by a physician,
  • The IM injection was administered in the pediatric emergency department,
  • No history of chronic pain-causing illness,
  • No diagnosis of neurodevelopmental disorders,
  • Had not received any analgesic medications in the past 6 hours,
  • No history of syncope (fainting) during previous injections,

No diagnosis of mental retardation,

  • No scar tissue or muscle atrophy at the intended injection site,
  • Body mass index (BMI) percentile between the 10th and 90th percentiles for age and gender,
  • Both child and parent provided informed consent to participate in the study.

Exclusion Criteria;

  • Participants were excluded from the study if:
  • The child was younger than 4 or older than 6 years,
  • There was scar tissue or muscle atrophy at the injection site,
  • The child or parent had communication difficulties,
  • The child's BMI was below the 10th percentile (cachectic) or above the 90th percentile (obese),
  • Either the child or parent declined to participate in the research.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 4 patient groups

intervention group Palm
Experimental group
Description:
Palm stimulator
Treatment:
Other: Palm
intervention group ShotBloker
Experimental group
Description:
ShotBloker device
Treatment:
Other: ShotBlocker
intervention group HSTT
Experimental group
Description:
HSTT application
Treatment:
Other: HSTT
Control group
No Intervention group
Description:
Rutin

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems