Two Different Tactile Stimulus Methods

Adiyaman University Research Hospital

Status: Completed

Conditions: Pain

Treatments: Device: Palm Stimulator; Device: ShotBlocker

Study type: Interventional

Funder types: Other

Identifiers

NCT04594083

2018/146

Details and patient eligibility

About

This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.

Full description

Objectives: This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.

Design: The study was conducted via a randomized controlled design. Setting: The study population consisted of children in the seven to 10 age group admitted to the emergency department of a public hospital (Kahta State Hospital) between February 2019 and July 2019 and who received an IM injection as part of the medical treatment.

Interventions: The study data were collected from the children, who were divided into Palm Stimulator, ShotBlocker, and control groups.

Main outcome measures: The children's pre-procedure fear levels were evaluated using the Children's Fear Scale (CFS), and their pain levels during the procedure were evaluated using the Facial Pain Scale-Revised (FPS-R). The children also reported injection-related pain levels using the Visual Analog Scale (VAS).

Enrollment: 159 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: children who

• had no diagnosed physical or mental disability or chronic illness;
• had no communication problems;
• received single injection,
• required Ampicillin + Sulbactam group of antibiotics for standardization; and
• received ventrogluteal muscle injection during the study.

Exclusion Criteria:

• Parents who were unable to collaborate in the fear and pain evaluation,
• overweight or underweight children (under the third or above the 97th percentile),
• children with any incision or scar tissue in the injection area,
• children who received a sedative, analgesic, or narcotic drugs (based on expert opinion) six hours before the procedure on the basis of parental statements and medical history

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 3 patient groups

Palm Stimulator

Experimental group

Description:

The Palm Stimulator was placed in the palm of the child's active hand 20 seconds before the injection. It ensured by researcher that the apparatus was held tightly in the child's palm throughout the procedure. The apparatus was taken back from the child after completing the injection process.

Treatment:

Device: Palm Stimulator

ShotBlocker

Experimental group

Description:

ShotBlocker was placed in the ventrogluteal area properly 20 seconds before injection. It was fixed at the injection site until the injection process was completed.

Treatment:

Device: ShotBlocker

Control

No Intervention group

Description:

The routine IM injection was applied to the children in the control group.