Pain MeasurementNCT05822336
Duration of IM Injection and Pain Intensity
A study testing Duration of Intramuscular Injections in people with Pain Measurement, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Duration of Intramuscular Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Pain Intensity and Intramuscular Injection
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
Read the 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.
- Conditions
- Pain Measurement
- Being tested
- Duration of Intramuscular Injections
- Keywords
- Intramusculer Injection, Nurse, Pain Intensity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of Intramuscular InjectionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Pain Expressions Scale
Between one to ten
Measured: after implamention in 1-2 seconds
Visual Pain Comparison Scale
Six level: Between zero to six
Measured: after implamention in 1-2 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Mar 2019
- Primary completion1 Apr 2019
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Repeated measure
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leman Şenturan, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822336
- Sponsor's protocol ID
- BiruniUn
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Pain Intensity and Intramuscular Injection
- ClinicalTrials.gov ID
- NCT05822336
- Acronym / sponsor ID
- BiruniUn
- Conditions
- Pain Measurement
- Keywords
- Intramusculer Injection, Nurse, Pain Intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Repeated measure
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Duration of Intramuscular InjectionsIn this group, the duration of IM injections was 40 seconds. The drug was the same for both groups, Clindamycin 600 mg/4 ml intramuscularly. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duration of Intramuscular InjectionsThis 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. | Other | Experimental arm |
Primary outcome
Facial Pain Expressions Scale
Time frame: after implamention in 1-2 seconds
Between one to ten
Visual Pain Comparison Scale
Time frame: after implamention in 1-2 seconds
Six level: Between zero to six
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Pain Measurement
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Recruiting
Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy
Postoperative Pain, Adenotonsillectomy
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Not yet recruitingObservational study
Pain Prediction Via Machine Learning: Electrical Thresholds and Interoception
University Students
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duration of Intramuscular Injections in people with Pain Measurement, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Pain Expressions Scale (time frame: after implamention in 1-2 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.