Duration of IM Injection and Pain Intensity

NCT05822336 | Completed

• 1 other identifier: BiruniUn
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a single-group crossover clinical trial, where each participant acted as their own control. The study aimed to describe the relationship between perceived pain and the duration of intramuscular injections

Conditions

Pain Measurement

Keywords

Intramusculer Injection; Nurse; Pain Intensity

Outcome Measures

Primary Outcomes (2)

• Facial Pain Expressions Scale

  Between one to ten

  after implamention in 1-2 seconds

• Visual Pain Comparison Scale

  Six level: Between zero to six

  after implamention in 1-2 seconds

Study Arms (2)

Experimental arm

EXPERIMENTAL

In this group, the duration of IM injections was 40 seconds. The drug was the same for both groups, Clindamycin 600 mg/4 ml intramuscularly.

Other: Duration of Intramuscular Injections

Active arm

NO INTERVENTION

In this group, the duration of IM injections was 10 seconds. The drug was the same for both groups, Clindamycin 600 mg/4 ml intramuscularly.

Interventions

Duration of Intramuscular Injections OTHER

This study was a single-group crossover clinical trial, where each participant acted as their own control. Two intramuscular injections into the right and left Dorsal Gluteal Region (DRG) were recorded for each participant. One was administered by a nurse, according to the unit's routine, and took 5 seconds to complete. A day after, the same nurse gave the other injection in the opposite DGR, taking 40 seconds to administer. The five-second injections were considered the control group, while the 40 seconds injections were the intervention group. The order of interventions was randomized. The pain level was determined and recorded immediately after each injection.

Experimental arm

Eligibility Criteria

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

You may qualify if:

• Having a condition leads to prescribing Clindamycin 600 mg/4 ml intramuscularly Having no pain in the area of injection Absence of any tissue damage history at the site of injection

You may not qualify if:

• Asking for withdrawal after signing the informed consent Intensifying the disease/condition at the time of the second injection Taking any analgesic medication before the application.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Leman Şenturan

Istanbul, Zeytinburnu, 34010, 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
• Masking Details: Single blind masking
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Repeated measure

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 20, 2023
• Study Start: March 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2021
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

TU (1)