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

NCT04883723 | Completed

• 1 other identifier: Ali KAPLAN-Erciyes University
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intramuscular Injection

Keywords

shotblocker; manual pressure; İntramuscular injection; pain; injection satisfaction

Outcome Measures

Primary Outcomes (2)

• Visual Benchmark Scale

  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.

  Immediately after the injection

• Injection Satisfaction Rating Scale

  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.

  Immediately after the injection

Study Arms (3)

Experiment I (Shotblocker) Group

EXPERIMENTAL

Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position. The determined injection site was cleaned with a cotton pad with alcohol, with circular movements of 5 cm diameter from inside to outside, and the alcohol was allowed to dry. The protruding surface of the Shotblocker was placed in the area just before the injection, so that the needle entry point would not be contaminated. It was lightly pressed into the shotblocker with fingertips and the injection was performed. ShotBlocker has been removed after removing the needle. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled.

Device: Shotblocker

Experiment II (Manual Pressure) Group

EXPERIMENTAL

Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. 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. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled.

Other: Manual Pressure

Control Group

NO INTERVENTION

The patients in the Manual Pressure group were given detailed information about the procedure and the research, and the patients who agreed to participate in the study were signed by an informed consent form. Before the injection, the heart rate and blood pressure values of the patient were measured and recorded. The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Injection was given using the normal intramuscular injection procedure. Visual comparison scale and injection satisfaction evaluation scale were applied to the patient in the first minute after the intramuscular injection. The obtained scores were recorded in the patient identification form. Pulse and blood pressure values were measured and recorded again. Finally, the patient introduction form was filled.

Interventions

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

Experiment I (Shotblocker) Group

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.

Experiment II (Manual Pressure) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: During the data collection, 120 individuals who met the inclusion criteria and were selected with the randomization list created on the computer constituted the sample of the study.

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: April 22, 2019
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)