Two Different Tactile Stimulus Methods

NCT04594083 | Completed

• 1 other identifier: 2018/146
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain management; child; nursing practice; Intramuscular Injection

Outcome Measures

Primary Outcomes (3)

• Children's Fear Scale (CFS)

  The Children's Fear Scale (CFS) is a scale used to assess the level of anxiety in children. The scale is a visual measurement tool with scores ranging from 0-4 points. It consists of five facial expressions, ranging from a neutral to a frightened expression, and is suitable for use with children aged 5-10 years (Inan \& Inal, 2019; McMurtry, Noel, Chambers, \& McGrath, 2011; Özalp Gerçeker, Ayar, Özdemir, \& Bektaş, 2018). The evaluation of the Turkish psychometric properties of the scale, which was developed by McMurty et al. for paediatric patients, was conducted by Özalp Gerçeker et al. (2018), and the scale was translated into the Turkish language (Özalp Gerçeker et al., 2018). The CFS has demonstrated good evidence of test-retest (r = 0.76, p \< 0.001), and inter-rater (0.51, P \< 0.001) reliability, as well as construct validity, (rs ¼ when used with children (McMurtry vd., 2011).

  5 months

• Faces Pain Scale-Revised (FPS-R)

  The Faces Pain Scale-Revised (FPS) is a scale used to assess the level of pain in children in the 4-12 age group (Hicks, Von Baeyer, Spafford, Van Korlaar, \& Goodenough, 2001). There are facial expressions that show the increasing levels of pain severity from left to right in the scale. Rated according to the severity of pain (between 0-10 points), the leftmost face refers to "no pain", and the rightmost face refers to "too much pain", comprising a total of six facial expressions. The faces exhibit an increase in pain severity to correspond with the scores 0, 2, 4, 6, 8, and 10 from left to right, respectively (Mohamed Mohamed Tork, 2017).

  5 months

• Visual Analog Scale (VAS)

  The VAS consists of a horizontal or vertical ruler 10 cm/100 mm in length, with the phrase "no pain" on one end and "the worst pain imaginable" on the other. The child is asked to mark the point on this line that most accurately reflects his/her pain. The distance between the child's mark and the left end of the scale is measured in cm and recorded as "points". It has been suggested that the widely researched scale should be used for children aged seven and older (Çelik \& Khorshid, 2015; Sivri Bilgen \& Balcı, 2019).

  5 months

Study Arms (3)

Palm Stimulator

EXPERIMENTAL

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.

Device: Palm Stimulator

ShotBlocker

EXPERIMENTAL

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.

Device: ShotBlocker

Control

NO INTERVENTION

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

Interventions

Palm Stimulator 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.

Palm Stimulator

ShotBlocker 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.

ShotBlocker

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Kahta State Hospital

Adıyaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Mürşide Zengin

  Adiyaman University

  PRINCIPAL INVESTIGATOR

• Emriye Hilal Yayan

  İnönü University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled, and experimental design

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: February 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: February 7, 2020
• Last Updated: January 14, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)