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Duration of IM Injection and Pain Intensity

Primary Purpose

Pain Measurement

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Duration of Intramuscular Injections
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain Measurement focused on measuring Intramusculer Injection, Nurse, Pain Intensity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Leman Şenturan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental arm

Active arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Facial Pain Expressions Scale
Between one to ten
Visual Pain Comparison Scale
Six level: Between zero to six

Secondary Outcome Measures

Full Information

First Posted
March 17, 2023
Last Updated
April 19, 2023
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05822336
Brief Title
Duration of IM Injection and Pain Intensity
Official Title
The Relationship Between Pain Intensity and Intramuscular Injection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Measurement
Keywords
Intramusculer Injection, Nurse, Pain Intensity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated measure
Masking
Participant
Masking Description
Single blind masking
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Active arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Duration of Intramuscular Injections
Intervention Description
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.
Primary Outcome Measure Information:
Title
Facial Pain Expressions Scale
Description
Between one to ten
Time Frame
after implamention in 1-2 seconds
Title
Visual Pain Comparison Scale
Description
Six level: Between zero to six
Time Frame
after implamention in 1-2 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Leman Şenturan
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Duration of IM Injection and Pain Intensity

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