Testing Different Methods of Intramuscular Injection

NCT05577832 | Completed

• 1 other identifier: MusAlparlanU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare in different injection techniques. The main question\[s\] it aims to answer are:

• Is there a difference between the pain levels due to needle insertion in the injection made with the HST Technique, the ShotBlocker technique and the standard technique?
• Is there a difference between the hematoma levels of the injection made with the HST Technique, the ShotBlocker technique and the standard technique?
• Is there a difference between the comfort levels of the injection made with the HST Technique, ShotBlocker technique and standard technique?
• Is there a difference between the satisfaction levels of the patients with the injection made with the HST Technique, ShotBlocker technique and standard technique?
• Is there a difference between the injection fear levels of patients with HST Technique, ShotBlocker technique and standard technique?

Conditions

Injection Fear; Injection Site Bruising; Pain, Acute; Satisfaction, Patient; Hematoma

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS)

  Patients will be asked to indicate and mark their post-injection pain, comfort, satisfaction, and fear of injection, with a minimum of 1 and a maximum of 10.

  3 days

• Opsite-Flexigrid Measurement Registration Form

  The Opsite-Flexigrid Measuring Tool is an easy-to-use film cover with transparent adhesive and moisture permeability. Opsite-Flexigrid consists of a thin polyurethane membrane coated with an acrylic adhesive layer. It is used in the measurement of hematoma diameter due to its small squares and transparency. After each injection, this tape will be attached to the arm of the individual with the injection site exposed, and will be used to determine the presence of hematoma in the individual 48 hours later. It consists of squares of centimeters divided into 10 parts of 0.1mm. Hematoma sizes measured with a transparent tape will be considered as pinpoint = needle tip if a spot-shaped color change has occurred at the needle entry point, medium if it is between 0.2-1 cm2, and large hematoma if it is larger than 1 cm2. The obtained data will be recorded in the form.

  3 days

Study Arms (1)

Experimental

EXPERIMENTAL

3 different injection techniques in Single Group design, 1 ml intramuscular injection of dodex amp 1 ml will be applied to the deltoid muscle, one technique per week, for 1 weeks(3 day). The effects of the three techniques on pain, satisfaction with hematoma, comfort and fear of injection will be compared.

Procedure: Helfer Skin Tap Technique; Procedure: ShotBlocker Technique; Procedure: Standard Technique

Interventions

Helfer Skin Tap Technique PROCEDURE

In a single-group design, 3 technique injections will be administered to the patients, to be randomized. The HST technique will be applied to patients in any one of 1days in a randomized fashion.

Experimental

ShotBlocker Technique PROCEDURE

In a single-group design, 3 technique injections will be administered to the patients, 1 technique per week, to be randomized. The ShotBlocker technique will be applied to patients in any one of 1 weeks(3 days) in a randomized manner.

Experimental

Standard Technique PROCEDURE

Standard Technique In a single-group design, 3 technique injections will be administered to the patients, 1 technique per days, to be randomized. The standard technique will be applied to patients in any one of 1 weeks in a randomized fashion.

Experimental

Eligibility Criteria

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

You may qualify if:

• be over 18 years old
• Having intramuscular Dodex 1 ml amp injection treatment once a week for at least 3 consecutive weeks
• Not using anticoagulant drugs
• Absence of scarring, incision, lipodystrophy, infection at the injection site
• Absence of a history of drug allergy
• Absence of any disease that prevents perception of pain, fear and similar variables (vision, hearing, loss of sensation, cognitive disability, stroke, DM)
• Not using centrally or peripherally effective analgesics or sedatives
• Lack of arm limbs
• Body mass index within normal limits
• Prescribing Dodex amp 1 ml

You may not qualify if:

• Failure to show up 3 times for injection administration
• Drug-induced allergy development
• The patient's desire to withdraw from the study

Sponsors & Collaborators

• Muş Alparslan University: lead
• Ataturk University: collaborator

Study Sites (1)

Atatürk University

Erzurum, Erzusum, 25100, Turkey (Türkiye)

Location

Related Publications (1)

• Yildiz GN, Ciftci B. Deltoid muscle intramuscular injection methods examining pain comfort satisfaction and fear in ShotBlocker helfer skin tap and standard techniques. BMC Nurs. 2025 Apr 8;24(1):390. doi: 10.1186/s12912-025-02901-8.

  PMID: 40200340 DERIVED

MeSH Terms

Conditions

Iatrophobia; Acute Pain; Patient Satisfaction; Hematoma

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Hemorrhage; Pathologic Processes

Study Officials

• Bahar Çiftçi

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 13, 2022
• Study Start: May 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 25, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

TU (1)