PainNCT07258953
ShotBlocker, Cold Needling, and Both Methods in Combination Pain and Satisfaction
A study testing ShotBlocker+cold needle, Cold needle and ShotBlokcer in people with Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Intramuscular (IM) injections are one of the most frequently used pharmacological treatment methods in nursing practice. Reducing the pain experienced by patients during this procedure and ensuring patient satisfaction are important indicators of treatment quality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- ShotBlocker+cold needle, Cold needle and ShotBlokcer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 4 May 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be between 18 and 65 years of age.
- Must have no problems speaking and understanding Turkish.
- Must have been prescribed 1000 mcg (1 ml ampoule) of cyanocobalamin IM injection.
- Must use the deltoid region for the injection.
- Must not be in the menstrual cycle.
- Must not be pregnant.
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- Must have no history of diabetes.
- Must have a Body Mass Index (BMI) between 18.5 and 30.
- Must have no scars, incisions, lipodystrophy, or infection at the injection site.
- Must have no history of allergy to the medication.
- Must have no pain, fear, etc. The inclusion criteria for the study were: not having any illness that prevents the perception of variables (vision, hearing, sensory loss, cognitive impairment, stroke, etc.),
- not using centrally or peripherally acting analgesics or sedatives,
- not having limb impairments,
- having a VAS score of "0" before the injection,
- agreeing to participate in the study.
Who cannot join
- Chronic or acute pain,
- Receiving oral or parenteral analgesic treatment before the study,
- Receiving another injection in the deltoid region,
- Developing a drug-related allergy or other complication,
- Having a contact-related infectious disease,
- Participants wishing to withdraw from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intramuscular Injection Using ShotBlocker, Cold Needling, and Both Methods in Combination on Pain and Satisfaction: A Randomized Controlled Trial
Intramuscular (IM) injections are one of the most frequently used pharmacological treatment methods in nursing practice. Reducing the pain experienced by patients during this procedure and ensuring patient satisfaction are important indicators of treatment quality. Reducing injection-related pain should be a priority in nursing care for both patient safety and the effectiveness of the treatment process.
This study is a trpile-blind, randomized, controlled trial. It was designed to evaluate the effects of ShotBlocker, cold needle, and a combination of both methods during intramuscular injection on patient pain levels and satisfaction. The research will be conducted in the injection unit affiliated with the Adult Emergency Department of Konya City Hospital, Ministry of Health of the Republic of Turkey. The study population will consist of patients who presented for cyanocobalamin injections, and the sample will consist of 132 individuals who voluntarily agreed to participate in the study and met the inclusion criteria. Before conducting the study, ethical approval will be obtained from the Necmettin Erbakan University Health Sciences Ethics Committee and from the Konya City Hospital of the Ministry of Health of the Republic of Turkey. Collected data will be analyzed using the SPSS statistical package program (version 22.0; SPSS Inc., USA). The Kolmogorov-Smirnov test will be used to assess whether the data exhibit a normal distribution; statistical significance will be accepted as p<0.05.
Read the detailed description
In parallel with the changes and developments in the healthcare field worldwide and in Türkiye, it is crucial that nursing practices are based on scientific knowledge and are evidence-based. Nurses must integrate the most up-to-date information into their practices in patient care. Medication administration, a fundamental element of medical treatment, is among nurses' legal responsibilities and requires great professional care and meticulousness. Medication administration is performed by nurses through various routes, including parenteral, topical, inhalation, and oral administration.
Intramuscular injection is a parenteral drug administration method, administering the medication deep into muscle tissue. It is frequently used in clinical practice. It is a riskier procedure than other injection methods, so it should be performed by professionals.
Intramuscular injections can lead to serious complications if the correct technique is not used. These complications include nerve damage, vascular or tissue damage, infection, abscess, hematoma, tissue necrosis, muscle stiffness, tingling, and the rare Nicolau syndrome. The most common complication is pain during the injection. In one study, participants underwent intravenous, intramuscular, and spinal injections, and when pain levels were compared, it was determined that the highest pain level was felt during the intramuscular injection. This result suggests that intramuscular injections may cause more pain compared to other injection types. Reducing the pain felt due to needle insertion during intramuscular injection alleviates individuals' anxiety and fears about the procedure and contributes to an increase in their satisfaction with the injection procedure. There are studies on the level of satisfaction with intramuscular injection procedures. These are: Techniques such as acupressure , ShotBlocker , cold needling , helfer skin tap (HSTT) , and vibration stimulation have been found to increase patient satisfaction with the treatment. Pharmacological, non-pharmacological, and surgical techniques can be used to reduce pain. Firstly, the use of non-pharmacological methods to control pain is important. Accordingly, nurses utilize various nonpharmacological methods to reduce pain and increase patient comfort. Correct patient positioning, use of appropriate equipment, changing the needle tip after withdrawal, and applying the Z technique and the airlock technique for irritating medications are effective in reducing pain during intramuscular injections. Additionally, skin stimulation techniques such as massage, menthol application, ShotBlocker, vibration, hot-cold application, cold needle technique, Buzzy, TENS, manual pressure, and helfer skin tap, as well as cognitive methods such as listening to music, relaxation, and distraction are also helpful in relieving pain. According to Gate Control Theory, one of the theories used to reduce pain, mechanical stimuli such as touch or manual pressure activate large nerve fibers, blocking the pain signals carried by small fibers in the spinal cord. This prevents the brain from perceiving the pain signal. Manual pressure applied before the injection allows the release of natural pain-relieving hormones such as endorphins, which raises the pain threshold. It increases blood circulation, reduces the perception of pain, and promotes tissue healing. Thanks to these mechanisms, pain can be effectively reduced through non-pharmacological methods. Literature has shown that the helfer skin tap technique reduces pain in newborns, children, and adults. Internal rotation of the extremity during intramuscular injection has been found to be effective in reducing injection pain and relaxing muscles. Various clinical studies in different age groups have shown that Buzzy is effective in reducing pain during needle procedures. The ShotBlocker, with its ridged surface applied by pressing on the skin, helps reduce the perception of pain by providing a physical stimulus with its blunt tips during injection. Its mechanism of action is that the projections exert pressure on the skin by stimulating fast nerve endings, temporarily blocking slower pain signals. This method reduces pain. Studies on children and adults have found it effective in reducing pain. Studies on the use of cold application and cold spray have determined that these methods significantly reduce post-injection pain. Studies using the cold needle technique show that this method is effective in reducing pain felt during injections in both children and adults. This technique is implemented by cooling the syringe tip to 0-2°C before injection and aims to reduce the patient's perception of pain during the injection. A review of the literature reveals that many studies have been conducted using various methods to reduce pain during intramuscular injection. Studies comparing ShotBlocker with other methods are quite common. However, the number of studies on the cold needle technique is limited. Only one study has been found in the literature that evaluated the effects of ShotBlocker and cold needle methods on pain and satisfaction during injection.
This study is the first to compare the effects of ShotBlocker and cold needle methods on pain and satisfaction during intramuscular injection, and to examine the effects of using these two methods together on pain and satisfaction during intramuscular injection. The lack of any studies in the literature on the simultaneous use of these two methods makes this study scientifically original. In this context, the study will not only make an innovative contribution to existing knowledge but also have the potential to develop concrete and applicable solutions to increase patient satisfaction in nursing practice. It is believed that the data obtained regarding the combined use of these easy-to-implement, economical, and time-practical methods will make unique contributions to both clinical practice and the literature.
- Conditions
- Pain
- Being tested
- ShotBlocker+cold needle, Cold needle, ShotBlokcer, Control
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlocker+cold needleOther
During intramuscular injection, ShotBlocker and the cold needle will be used simultaneously.
Cold needleOther
A cold needle will be used during intramuscular injection.
ShotBlokcerOther
ShotBlocker will be used during intramuscular injection.
ControlOther
Intramuscular injection will be conducted according to standard technique.
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker+cold needle | Experimental | During intramuscular injection, ShotBlocker and the cold needle will be used simultaneously. Receives: Other: ShotBlocker+cold needle |
| Cold needle | Experimental | ShotBlocker will be used during intramuscular injection. Receives: Other: ShotBlokcer |
| ShotBlocker | Experimental | A cold needle will be used during intramuscular injection. Receives: Other: Cold needle |
| Control | Placebo comparator | Intramuscular injections will be performed according to standard technique. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Pain Scale (VAS)
After the injection, the pain level will be determined using VAS.The lowest VAS score is "0" and the highest is "10." A higher score indicates greater pain.
Measured: up to 5 months
Secondary outcomes (1)
Injection satisfaction
After the injection, patient satisfaction will be assessed. At this stage, patients will be asked to rate their satisfaction on a scale of 1-10.
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Apr 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: ShotBlocker Group 2: Cold Needle Group 3: ShotBlocker + Cold Needle Group 4: Control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 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
- Investigators
- Yadigar Yadigar, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258953
- Sponsor's protocol ID
- ShotBlocker and Cold Needle
- Status last verified
- May 2026
- First submitted
- 26 Sep 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intramuscular Injection Using ShotBlocker, Cold Needling, and Both Methods in Combination on Pain and Satisfaction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07258953
- Acronym / sponsor ID
- ShotBlocker and Cold Needle
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 2 Dec 2025 (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.
Intramuscular (IM) injections are one of the most frequently used pharmacological treatment methods in nursing practice. Reducing the pain experienced by patients during this procedure and ensuring patient satisfaction are important indicators of treatment quality. Reducing injection-related pain should be a priority in nursing care for both patient safety and the effectiveness of the treatment process.
This study is a trpile-blind, randomized, controlled trial. It was designed to evaluate the effects of ShotBlocker, cold needle, and a combination of both methods during intramuscular injection on patient pain levels and satisfaction. The research will be conducted in the injection unit affiliated with the Adult Emergency Department of Konya City Hospital, Ministry of Health of the Republic of Turkey. The study population will consist of patients who presented for cyanocobalamin injections, and the sample will consist of 132 individuals who voluntarily agreed to participate in the study and met the inclusion criteria. Before conducting the study, ethical approval will be obtained from the Necmettin Erbakan University Health Sciences Ethics Committee and from the Konya City Hospital of the Ministry of Health of the Republic of Turkey. Collected data will be analyzed using the SPSS statistical package program (version 22.0; SPSS Inc., USA). The Kolmogorov-Smirnov test will be used to assess whether the data exhibit a normal distribution; statistical significance will be accepted as p<0.05.
Detailed description
In parallel with the changes and developments in the healthcare field worldwide and in Türkiye, it is crucial that nursing practices are based on scientific knowledge and are evidence-based. Nurses must integrate the most up-to-date information into their practices in patient care. Medication administration, a fundamental element of medical treatment, is among nurses' legal responsibilities and requires great professional care and meticulousness. Medication administration is performed by nurses through various routes, including parenteral, topical, inhalation, and oral administration.
Intramuscular injection is a parenteral drug administration method, administering the medication deep into muscle tissue. It is frequently used in clinical practice. It is a riskier procedure than other injection methods, so it should be performed by professionals.
Intramuscular injections can lead to serious complications if the correct technique is not used. These complications include nerve damage, vascular or tissue damage, infection, abscess, hematoma, tissue necrosis, muscle stiffness, tingling, and the rare Nicolau syndrome. The most common complication is pain during the injection. In one study, participants underwent intravenous, intramuscular, and spinal injections, and when pain levels were compared, it was determined that the highest pain level was felt during the intramuscular injection. This result suggests that intramuscular injections may cause more pain compared to other injection types. Reducing the pain felt due to needle insertion during intramuscular injection alleviates individuals' anxiety and fears about the procedure and contributes to an increase in their satisfaction with the injection procedure. There are studies on the level of satisfaction with intramuscular injection procedures. These are: Techniques such as acupressure , ShotBlocker , cold needling , helfer skin tap (HSTT) , and vibration stimulation have been found to increase patient satisfaction with the treatment. Pharmacological, non-pharmacological, and surgical techniques can be used to reduce pain. Firstly, the use of non-pharmacological methods to control pain is important. Accordingly, nurses utilize various nonpharmacological methods to reduce pain and increase patient comfort. Correct patient positioning, use of appropriate equipment, changing the needle tip after withdrawal, and applying the Z technique and the airlock technique for irritating medications are effective in reducing pain during intramuscular injections. Additionally, skin stimulation techniques such as massage, menthol application, ShotBlocker, vibration, hot-cold application, cold needle technique, Buzzy, TENS, manual pressure, and helfer skin tap, as well as cognitive methods such as listening to music, relaxation, and distraction are also helpful in relieving pain. According to Gate Control Theory, one of the theories used to reduce pain, mechanical stimuli such as touch or manual pressure activate large nerve fibers, blocking the pain signals carried by small fibers in the spinal cord. This prevents the brain from perceiving the pain signal. Manual pressure applied before the injection allows the release of natural pain-relieving hormones such as endorphins, which raises the pain threshold. It increases blood circulation, reduces the perception of pain, and promotes tissue healing. Thanks to these mechanisms, pain can be effectively reduced through non-pharmacological methods. Literature has shown that the helfer skin tap technique reduces pain in newborns, children, and adults. Internal rotation of the extremity during intramuscular injection has been found to be effective in reducing injection pain and relaxing muscles. Various clinical studies in different age groups have shown that Buzzy is effective in reducing pain during needle procedures. The ShotBlocker, with its ridged surface applied by pressing on the skin, helps reduce the perception of pain by providing a physical stimulus with its blunt tips during injection. Its mechanism of action is that the projections exert pressure on the skin by stimulating fast nerve endings, temporarily blocking slower pain signals. This method reduces pain. Studies on children and adults have found it effective in reducing pain. Studies on the use of cold application and cold spray have determined that these methods significantly reduce post-injection pain. Studies using the cold needle technique show that this method is effective in reducing pain felt during injections in both children and adults. This technique is implemented by cooling the syringe tip to 0-2°C before injection and aims to reduce the patient's perception of pain during the injection. A review of the literature reveals that many studies have been conducted using various methods to reduce pain during intramuscular injection. Studies comparing ShotBlocker with other methods are quite common. However, the number of studies on the cold needle technique is limited. Only one study has been found in the literature that evaluated the effects of ShotBlocker and cold needle methods on pain and satisfaction during injection.
This study is the first to compare the effects of ShotBlocker and cold needle methods on pain and satisfaction during intramuscular injection, and to examine the effects of using these two methods together on pain and satisfaction during intramuscular injection. The lack of any studies in the literature on the simultaneous use of these two methods makes this study scientifically original. In this context, the study will not only make an innovative contribution to existing knowledge but also have the potential to develop concrete and applicable solutions to increase patient satisfaction in nursing practice. It is believed that the data obtained regarding the combined use of these easy-to-implement, economical, and time-practical methods will make unique contributions to both clinical practice and the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Group 1: ShotBlocker Group 2: Cold Needle Group 3: ShotBlocker + Cold Needle Group 4: Control
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker+cold needle | Experimental | Other: ShotBlocker+cold needleDuring intramuscular injection, ShotBlocker and the cold needle will be used simultaneously. |
| Cold needle | Experimental | Other: ShotBlokcerShotBlocker will be used during intramuscular injection. |
| ShotBlocker | Experimental | Other: Cold needleA cold needle will be used during intramuscular injection. |
| Control | Placebo comparator | Other: ControlIntramuscular injections will be performed according to standard technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Must be between 18 and 65 years of age.
- Must have no problems speaking and understanding Turkish.
- Must have been prescribed 1000 mcg (1 ml ampoule) of cyanocobalamin IM injection.
- Must use the deltoid region for the injection.
- Must not be in the menstrual cycle.
Key exclusion criteria (6 listed)
- Chronic or acute pain,
- Receiving oral or parenteral analgesic treatment before the study,
- Receiving another injection in the deltoid region,
- Developing a drug-related allergy or other complication,
- Having a contact-related infectious disease,
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 |
|---|---|---|
| ShotBlocker+cold needleDuring intramuscular injection, ShotBlocker and the cold needle will be used simultaneously. | Other | ShotBlocker+cold needle |
| Cold needleA cold needle will be used during intramuscular injection. | Other | ShotBlocker |
| ShotBlokcerShotBlocker will be used during intramuscular injection. | Other | Cold needle |
| ControlIntramuscular injection will be conducted according to standard technique. | Other | Control |
Primary outcome
Visual Pain Scale (VAS)
Time frame: up to 5 months
After the injection, the pain level will be determined using VAS.The lowest VAS score is "0" and the highest is "10." A higher score indicates greater pain.
1 secondary outcome
Injection satisfaction
Time frame: up to 5 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 18 May 2026.
- Individual participant dataSharing planned: No
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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.
Yadigar Yadigar principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShotBlocker+cold needle, Cold needle and ShotBlokcer in people with Pain, 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 6 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 18 May 2026. 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. Some participants in this study may receive a placebo. 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?
Visual Pain Scale (VAS) (time frame: up to 5 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 18 May 2026.