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Completed

NCT Number: NCT04594083

Two Different Tactile Stimulus Methods

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.

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Key information

Conditions

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

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahta State Hospital

Adıyaman, 02100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Children's Fear Scale (CFS)

    Time frame: 5 months

    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).

  2. Faces Pain Scale-Revised (FPS-R)

    Time frame: 5 months

    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).

  3. Visual Analog Scale (VAS)

    Time frame: 5 months

    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).

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

A Comparison of Two Different Tactile Stimulus Methods on Reducing Pain

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 20, 2020
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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