Effectiveness of Two Different Methods During Intramuscular Antibiotic Injection: ShotBlocker, Local Vibration

NCT04851158 | Completed

• 1 other identifier: 20210067
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

In intramuscular injection applications, which are among the responsibilities and basic skills of nurses, different methods are used to reduce the pain caused by injection and increase the individual's satisfaction. ShotBlocker and local vibration are among the methods used for this purpose. The aim of the study is to examine the effectiveness of ShotBlocker and local vibration, which are among the non-pharmacological methods, on the perceived pain and satisfaction during ventrogluteal intramuscular antibiotic injection. This randomized, controlled experimental study will be carried out in the adult emergency clinic of a training and research hospital in Istanbul between February and April 2021.

Conditions

Injections; Pain; Satisfaction, Patient

Keywords

Intramuscular injection; pain; ShotBlocker; local vibration; nursing

Outcome Measures

Primary Outcomes (2)

• Using ShotBlocker and local vibrator device during intramuscular antibiotic injection reduces the patient's injection related pain.

  The change from baseline in pain scores will be measured immediately after intramuscular injection using Visual Analogue Scale (VAS) for pain. On a ten-centimetre long horizontal line, there are definitions of "no pain" at the left end and "unbearable pain" at the right end. High scores indicate a high level of pain.

  The procedure will take a total of 10 minutes.

• Using ShotBlocker and local vibrator device during intramuscular antibiotic injection increases the patient's injection related satisfaction.

  The change from baseline in satisfaction scores will be measured immediately after intramuscular injection using Visual Analogue Scale (VAS) for satisfaction. On a ten-centimetre long vertical line, there is the statement "Strongly dissatisfied" at the lower end of the line, and "Strongly satisfied" at the upper end. High scores indicate a high level of satisfaction.

  The procedure will take a total of 10 minutes.

Study Arms (3)

ShotBlocker

EXPERIMENTAL

ShotBlocker will be used on 35 patients. For the patient group that is applied ShotBlocker, after cleansing the skin, the protruding surface of the device is placed facing the skin surface. The injection is applied with the appropriate technique, then ShotBlocker is removed and a light pressure is applied to the area with a cotton pad for 15-20 seconds.

Device: Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injection

Local Vibration

EXPERIMENTAL

Local Vibration will be used on 35 patients. For the patient group that was subject to local vibration, local vibration was applied to the region with a vibrator for five minutes prior to injection, following a previous study on this subject. After that, 70% alcohol was used to cleanse the skin. The injection was applied with the appropriate technique, then a light pressure was applied to the area with a cotton pad for 15-20 seconds.

Device: Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injection

Control

NO INTERVENTION

For the control group (n=35), IM injection into the ventrogluteal region without using any tools is performed with the appropriate technique.

Interventions

Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injection DEVICE

Intervention: Verbal information was given to the participants prior to the intramuscular injection, and their written consents were obtained. The "Structured Information Form" consisting of five questions was applied by face-to-face interview method. Height and weight were measured, and BMI (kg/m2) was calculated and recorded in the "Structured Information Form". Application: ShotBlocker will be used on 35 patients during intramuscular injection. Final assessment: VAS will be applied immediately after the intramuscular injection to determine the pain and satisfaction levels of the participants.

ShotBlocker

Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injection DEVICE

Intervention: Verbal information was given to the participants prior to the intramuscular injection, and their written consents were obtained. The "Structured Information Form" consisting of five questions was applied by face-to-face interview method. Height and weight were measured, and BMI (kg/m2) was calculated and recorded in the "Structured Information Form". Application: Local vibrator device will be used on 35 patients during intramuscular injection. Final assessment: VAS will be applied immediately after the intramuscular injection to determine the pain and satisfaction levels of the participants.

Local Vibration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over the age of 18, Having no communication problem such as seeing, hearing and understanding problem,
• Having no disease that can cause sensory loss,
• Not having had IM injection in the last week, Having no complication related to IM injections such as pain, abscess, infection, tissue necrosis, and hematoma at the injection site.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Emergency Medicine Clinic

Göztepe, Istanbul, 34035, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kurtuluş Açıksarı

  Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Emergency Medicine Clinic

  STUDY CHAIR

• Alper Solakoğlu

  Göztepe Prof. Dr. Süleyman Yalçın City Hospital, Emergency Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The sample of the study consisted of volunteer patients who applied to the adult emergency service, and who were administered antibiotics (amoxicillin / cefuroxime sodium) upon the physician's request, and who met the inclusion criteria of the study. Criteria for inclusion in the study: * Being over the age of 18, * Having no communication problem such as seeing, hearing and understanding problem, * Having no disease that can cause sensory loss, * Not having had IM injection in the last week, * Having no complication related to IM injections such as pain, abscess, infection, tissue necrosis, and hematoma at the injection site.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The sample size was determined as 35 persons for each group at the 0.5 effect size and 0.05 error level with the power analysis performed by taking into account the numerical values of the findings obtained from a previous study on this subject. ShotBlocker group:35; Local vibration group: 35; Control group:35 person

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 20, 2021
• Study Start: April 20, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)