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Completed

NCT Number: NCT04883723

Effect of Manual Pressure and Shotblocker on Pain and Injection Satisfaction in Intramuscular Injection Application

This study was planned as a single blind randomized controlled experimental study to investigate the effect of manual pressure applied before injection and ShotBlocker's pain and injection satisfaction due to intramuscular injection. The sample of the study consisted of a total of 120 patients over the age of 18 who applied to the Emergency Service of a public hospital and were requested Diclofenac Sodium 75mg / 3ml. The patients were included in the experiment I (shotblocker), experiment II (manual compression) and the control group with the randomization list created on the computer.

In the ShotBlocker group, the ShotBlocker was kept throughout the injection, and in the manual compression group, manual pressure was applied to the injection area for 10 seconds before injection, and in the control group, IM injection was applied without using any tools. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. Visual Comparison Scale and Injection Satisfaction Scale were administered to the patient in the first minute after the injection. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled. Parametric or nonparametric statistical tests and correlation test were used in the analysis of the data.

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Key information

Conditions

Intramuscular Injection Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, 38380, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • He has not had an IM injection in the last week,
  • Upper respiratory tract infection patients in the Examination Department, where green field patients of the Emergency Service are located,
  • Over the age of 18,
  • No complications related to IM injections such as pain at the IM injection site, abscess, infection, tissue necrosis, hematoma,
  • Does not have pain anywhere in the body that will affect the work result,
  • Are conscious and have no communication problem,
  • No vision or hearing problems,
  • Not taking analgesic in the last 24 hours,
  • Does not have any known chronic disease,
  • No psychiatric disorder,
  • Diclofenac sodium ampoule has been ordered,
  • Can evaluate "Visual Comparison Scale and Injection Satisfaction Scale" correctly,
  • Individuals who volunteered to participate in the study and signed the written informed consent form were included.

Exclusion criteria

  • Not wanting to participate in the study,
  • Patients who did not meet the study acceptance criteria were not included.

Treatment and study plan

ShotBlocker

Device

Shotblocker is a small, flat, horseshoe-shaped plastic tool that can be used to reduce pain due to intramuscular injection, suitable for all age groups, without drug properties. It is used by keeping it on the skin surface during injection and has no side effects. Shotblocker has short, non-pointed blunt protrusions on one side that connect with the skin, there is a hole in the middle of the vehicle to expose the injection site. The protruding surface of the vehicle is placed in the area to be applied just before injection. The protrusions on the surface of the Shotblocker do not pierce the skin and provide a warning for the Door Control Theory, which is thought to exist regarding pain

Manual Pressure

Other

The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Pressure was applied to the determined injection area with the thumb of the active hand for 10 seconds. Immediately after the application of pressure was terminated, the injection site was cleaned with an alcohol cotton pad with circular movements of 5 cm diameter from inside to outside, and the alcohol was allowed to dry. With a single movement at a 90 ° angle, the compression area was entered quickly and the injection was performed. Manual pressure reduces pain within the framework of the gate control theory. According to the gate control theory, when pressure is applied to an area, a fiber transmits the feeling of pressure instead of pain and ultimately the pain sensation is alleviated. There are many studies in the literature that prove the effectiveness of this method.

Primary outcomes

  1. Visual Benchmark Scale

    Time frame: Immediately after the injection

    It is a one-dimensional scale used in the measurement of pain. It was found that the sensitivity of the visual comparison scale was higher than other methods in the assessment of pain severity. The scale consists of a 100 mm long line. On one end there are the words "No Pain" and "Unbearable Pain" on the other. The patient is instructed to mark a point on the line that accurately reflects his or her pain. Between the onset of no pain and this point marked by the patient, it is measured and recorded.

  2. Injection Satisfaction Rating Scale

    Time frame: Immediately after the injection

    The satisfaction level of the patients after injection was evaluated using a scale consisting of a 100 mm vertical line with "Very Satisfied" on one end and "Not Satisfied" on the other.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effect of Use of Manual Pressure and Shotblocker on Pain and Injection Satisfaction in the Application of Intramuscular Injection to the Ventrogluteal Region in Adult Patients

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 12, 2021
Registry last updated
May 13, 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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