Intramuscular InjectionNCT06443099
Needle and Shotblocker on Pain and Satisfaction in Intramuscular Injection Pain
A study testing Different methods used after intramuscular injection in people with Intramuscular Injection, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intramuscular Injection
- What is being tested?
- Different methods used after intramuscular injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2024to 30 Aug 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Needle and Shotblocker on Pain and Satisfaction in Intramuscular Injection Pain: A Randomized Controlled Trial
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.
Read the detailed description
This study aims to compare cold injection and ShotBlocker in intramuscular injection pain. This is a triple-blind randomized clinical trial. The population of the research will consist of patients who applied to the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital to receive cyanocobalamin injection between June and September 2024. Considering that losses may occur during the data collection process, the study will be completed with a total of 120 patients. The data of the study will be collected with the "Patient Diagnosis Form", "Visual Analog Scale (VAS)" and "Injection Satisfaction Scale". Block randomization method will be used to assign participants to groups. All injections will be performed by a single nurse working in the injection unit in accordance with the research procedure. Once the injection procedure is completed, participants will be asked to rate injection pain and satisfaction. Pain assessment will be performed by another emergency nurse who is independent from the study and contributes to the study. Researchers will participate in this process as observers. The people who will perform the application and evaluate the pain and satisfaction will be different. In this way, the person evaluating the pain will not know which application was performed on the participant, and blinding will be ensured. Additionally, the data of the study will be coded as A, B and C and entered into SPSS, thus ensuring statistical blinding. Thus, it is planned to conduct the research with triple blinding. All injections will be made using cyanocobalamin injection (1 ml), 5 cc syringe, 25 Gauge orange syringe tip. Before the injection, it will be checked whether the pain score is "0" with VAS. The participant will be given a Fowler position, the deltoid area will be checked on the arm to be treated, the arm will be flexed and brought closer to the body, and the position will be given. Injections will be given to each group according to the IM injection application protocol. Intramuscular injection will be applied to the deltoid muscle in the intervention-1 group, with a cold needle, in the intervention-2 group, with a shot blocker, and in the control group, with the standard method. Subjects will be determined by block randomization. All participants will be allowed to rest for two minutes after each injection. After two minutes, they will be asked to mark the level of pain caused by the procedure on the VAS. Similarly, they will be asked to mark their satisfaction with the procedure on the injection satisfaction scale. Then, the line marked by the person will be measured with a 10 cm ruler and the numerical equivalent of pain and satisfaction will be determined. Data will be compared between groups.
- Conditions
- Intramuscular Injection
- Being tested
- Different methods used after intramuscular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different methods used after intramuscular injectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 months
Secondary outcomes (1)
injection satisfaction
The injection satisfaction scale is a 0-10 cm ruler that will be used to evaluate patients' satisfaction with the injection application. Patients will mark their satisfaction with the injection application on the ruler.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start10 Jul 2024
- Primary completion20 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intramuscular InjectionStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yadigar Ordu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443099
- Sponsor's protocol ID
- Shotblocker
- Status last verified
- Oct 2024
- First submitted
- 29 May 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Needle and Shotblocker on Pain and Satisfaction in Intramuscular Injection Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06443099
- Acronym / sponsor ID
- Shotblocker
- Conditions
- Intramuscular Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 5 Jun 2024 (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.
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.
Detailed description
This study aims to compare cold injection and ShotBlocker in intramuscular injection pain. This is a triple-blind randomized clinical trial. The population of the research will consist of patients who applied to the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital to receive cyanocobalamin injection between June and September 2024. Considering that losses may occur during the data collection process, the study will be completed with a total of 120 patients. The data of the study will be collected with the "Patient Diagnosis Form", "Visual Analog Scale (VAS)" and "Injection Satisfaction Scale". Block randomization method will be used to assign participants to groups. All injections will be performed by a single nurse working in the injection unit in accordance with the research procedure. Once the injection procedure is completed, participants will be asked to rate injection pain and satisfaction. Pain assessment will be performed by another emergency nurse who is independent from the study and contributes to the study. Researchers will participate in this process as observers. The people who will perform the application and evaluate the pain and satisfaction will be different. In this way, the person evaluating the pain will not know which application was performed on the participant, and blinding will be ensured. Additionally, the data of the study will be coded as A, B and C and entered into SPSS, thus ensuring statistical blinding. Thus, it is planned to conduct the research with triple blinding. All injections will be made using cyanocobalamin injection (1 ml), 5 cc syringe, 25 Gauge orange syringe tip. Before the injection, it will be checked whether the pain score is "0" with VAS. The participant will be given a Fowler position, the deltoid area will be checked on the arm to be treated, the arm will be flexed and brought closer to the body, and the position will be given. Injections will be given to each group according to the IM injection application protocol. Intramuscular injection will be applied to the deltoid muscle in the intervention-1 group, with a cold needle, in the intervention-2 group, with a shot blocker, and in the control group, with the standard method. Subjects will be determined by block randomization. All participants will be allowed to rest for two minutes after each injection. After two minutes, they will be asked to mark the level of pain caused by the procedure on the VAS. Similarly, they will be asked to mark their satisfaction with the procedure on the injection satisfaction scale. Then, the line marked by the person will be measured with a 10 cm ruler and the numerical equivalent of pain and satisfaction will be determined. Data will be compared between groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| shotblocker group | Experimental | Other: Different methods used after intramuscular injectionIt 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. |
| Cold needle group | Experimental | Other: Different methods used after intramuscular injectionIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Different methods used after intramuscular injectionDifferent 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. | Other | Cold needle group, shotblocker group |
Primary outcome
injection pain
Time frame: up to 2 months
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.
1 secondary outcome
injection satisfaction
Time frame: up to 2 months
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 10 Oct 2024.
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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 Different methods used after intramuscular injection in people with Intramuscular Injection, run by Necmettin Erbakan 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 15 inclusion and 4 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 10 Oct 2024. 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?
injection pain (time frame: up to 2 months). 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 10 Oct 2024.