Needle and Shotblocker on Pain and Satisfaction in Intramuscular Injection Pain

NCT06443099 | Completed

• 1 other identifier: Shotblocker
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it is aimed to compare cold needle and shotblocker in intramuscular injection pain. This is a triple-blind randomized clinical trial. June September 2024, the universe of the research will be composed of patients who applied to the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital for cyanocobalamin injection. Considering that losses may occur during the data collection process, the study will be completed with a total of 120 patients. Intramuscular injection of the deltoid November will be applied to the intervention-1 group with a cold needle, intervention-2 group with a shotblocker, and the control group with the standard method. People will be determined by block randomization. After each application, the pain and satisfaction due to the injection will be evaluated. The data will be compared between the groups.

Conditions

Intramuscular Injection

Outcome Measures

Primary Outcomes (1)

• injection pain

  Visual Pain Scale (Visual Analog Scale-VAS) is a reliable measurement tool developed to measure individuals' pain levels. The scale is simple, interesting, quick to fill out, and easy to score. There are subjective descriptive expressions at both ends of a 10-cm ruler (0: lowest pain level and 10: highest pain level). The patient will be asked to mark the place on the line that expresses his/her pain.

  up to 2 months

Secondary Outcomes (1)

• injection satisfaction

  up to 2 months

Study Arms (3)

shotblocker group

EXPERIMENTAL

It is a C-shaped plastic tool with small blunt protrusions on one side that contact the skin. It does not have any side effects. The protruding surface of the ShotBlocker is pressed against the skin during injection and the injection is performed through the opening. It is thought to provide pain control as an application of gate control theory. In addition to the IM injection application procedure, after the skin is cleaned in the patient group, the protruding part of the ShotBlocker (Bionix, Press Firmly, USA) will be placed in contact with the skin. The ShotBlocker will be pressed firmly against the skin and the injection will be made through the central opening of the ShotBlocker. Once the injection is complete, the ShotBlocker will be removed from the skin.

Other: Different methods used after intramuscular injection

Cold needle group

EXPERIMENTAL

In addition to the IM injection procedure, a cold needle tip will be used in the needle tip changing procedure step. For this, before the application, the 25 Gauge orange syringe tip will be placed in a cold thermos and kept at 0-2 degrees Celsius with ice batteries. The appropriate temperature range will be checked with a digital thermometer.

Other: Different methods used after intramuscular injection

Control group

NO INTERVENTION

Applications will be carried out according to the IM injection application protocol. Identifying the deltoid region. Clean the area around the injection site (five cm) with 70% disposable alcohol cotton in circular motions, wait for the alcohol to dry in the area (5 seconds). Injecting the drug every 10 sec/ml. 10 seconds before withdrawing the needle. wait. Retracting the needle straight and steady at the angle at which the tissue was entered.

Interventions

Different methods used after intramuscular injection OTHER

Different methods will be used during intramuscular injection. One of them is shotblocker. There are studies reporting that it reduces pain according to the gate control theory. The other method is cold injection. In this method, the injector tips will be cooled to 0-2 degrees and used in injection application.

Cold needle group; shotblocker group

Eligibility Criteria

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

You may qualify if:

• Being between the ages of 18-65,
• No problems with speaking and understanding Turkish,
• Body mass index (BMI) between 18.5 and 30,
• Just starting the first dose of cyanocobalamin treatment,
• No history of allergy to the drug,
• No vision, hearing or perception problems,
• Having orientation to place and time,
• No sensorimotor deficit,
• No history of diabetes,
• Not taking oral or parenteral analgesic treatment before the application,
• VAS score before injection is "0",
• No deficiency in limbs,
• No pregnancy,
• Female individuals who are not in their menstrual cycle,
• Volunteering to participate in the research.

You may not qualify if:

• Another injection into the deltoid area,
• Development of drug-related allergy or other complications,
• Scar, incision, infection, sensitivity, burn, cut, etc. in the injection area. to be found,
• Wants to leave the research.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Teaching Member

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 5, 2024
• Study Start: July 10, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 30, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

TU (1)