Duration of IM Injection and Pain Intensity

Sponsor

Biruni University (Other)

Overall Status

Completed

CT.gov ID

NCT05822336

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain Measurement	Other: Duration of Intramuscular Injections	N/A

Detailed Description

The study was a single-group crossover clinical trial, where each participant acted as their own control. The study sample included 50 patients aged 25 to 55 who met the inclusion criteria of signing an informed consent form and requiring administration of a specific antibiotic via intramuscular injection, as prescribed by physicians.

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.

The study was conducted between September 2019 to November 2019 in the emergency unit of an educational hospital in Istanbul. The data was collected using a Demographic Form, Facial Expressions Scale, and Visual Comparison Scale. Statistical analysis was performed using the Kolmogorov-Smirnov test, Mann-Whitney U test, Wilcoxon test, and Spearman correlation analysis, with a significance level of p < 0.05.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Repeated measureRepeated measure

Masking:

Single (Participant)

Masking Description:

Single blind masking

Primary Purpose:

Other

Official Title:

The Relationship Between Pain Intensity and Intramuscular Injection

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental arm 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 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.
No Intervention: Active arm 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.

Arm

Intervention/Treatment

Experimental: Experimental arm

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

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.

No Intervention: Active arm

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.

Outcome Measures

Primary Outcome Measures

Facial Pain Expressions Scale [after implamention in 1-2 seconds]
Between one to ten
Visual Pain Comparison Scale [after implamention in 1-2 seconds]
Six level: Between zero to six

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leman Şenturan	Istanbul	Zeytinburnu	Turkey	34010

Sponsors and Collaborators

Biruni University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leman Şenturan, Prof. Dr., Biruni University

ClinicalTrials.gov Identifier:

NCT05822336

Other Study ID Numbers:

BiruniUn

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 20, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Leman Şenturan, Prof. Dr., Biruni University

Intramusculer Injection

Nurse

Pain Intensity

Additional relevant MeSH terms:

Pain

Study Results

No Results Posted as of Apr 20, 2023