Two Different Tactile Stimulus Methods

NCT ID: NCT04594083

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-02-07

Brief Summary

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.

Detailed 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).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Palm Stimulator

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.

Group Type: EXPERIMENTAL

Palm Stimulator

Intervention Type: DEVICE

The Palm Stimulator, developed by the present researchers for the first time, is 1.6 cm in diameter, 4 cm in length, and has a cylindrical, non-slippery structure for an easy grip to ensure maximum contact with the palm The Palm Stimulator consists of blunt protrusions that will provide a tactile stimulus on the palm. The blunt protrusions do not penetrate into the skin. The simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin.

ShotBlocker

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.

Group Type: EXPERIMENTAL

ShotBlocker

Intervention Type: DEVICE

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Palm Stimulator

The Palm Stimulator, developed by the present researchers for the first time, is 1.6 cm in diameter, 4 cm in length, and has a cylindrical, non-slippery structure for an easy grip to ensure maximum contact with the palm The Palm Stimulator consists of blunt protrusions that will provide a tactile stimulus on the palm. The blunt protrusions do not penetrate into the skin. The simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin.

Intervention Type: DEVICE

ShotBlocker

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Adiyaman University Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mürşide Zengin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mürşide Zengin

Role: PRINCIPAL_INVESTIGATOR

Adiyaman University

Emriye Hilal Yayan

Role: PRINCIPAL_INVESTIGATOR

İnönü University

Locations

Kahta State Hospital

Adıyaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018/146

Identifier Type: -

Identifier Source: org_study_id