ShotBlocker, Cold Needling, and Both Methods in Combination Pain and Satisfaction
NCT ID: NCT07258953
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
132 participants
INTERVENTIONAL
2026-02-01
2026-06-10
Brief Summary
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This study is a triple-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
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
All injections will be administered by a single nurse working in the unit where the injections will be administered. The researcher will participate solely as an observer, will not intervene, and will not know which patient is in which group.
Data obtained from the study will be coded as A, B, C, and D and submitted for statistical analysis.
By concealing the group information, the analysis will be conducted objectively.
Study Groups
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ShotBlocker+cold needle
During intramuscular injection, ShotBlocker and the cold needle will be used simultaneously.
ShotBlocker+cold needle
During intramuscular injection, ShotBlocker and the cold needle will be used simultaneously.
Cold needle
ShotBlocker will be used during intramuscular injection.
ShotBlokcer
ShotBlocker will be used during intramuscular injection.
ShotBlocker
A cold needle will be used during intramuscular injection.
Cold needle
A cold needle will be used during intramuscular injection.
Control
Intramuscular injections will be performed according to standard technique.
Control
Intramuscular injection will be conducted according to standard technique.
Interventions
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ShotBlocker+cold needle
During intramuscular injection, ShotBlocker and the cold needle will be used simultaneously.
Cold needle
A cold needle will be used during intramuscular injection.
ShotBlokcer
ShotBlocker will be used during intramuscular injection.
Control
Intramuscular injection will be conducted according to standard technique.
Eligibility Criteria
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Inclusion Criteria
2. Must have no problems speaking and understanding Turkish.
3. Must have been prescribed 1000 mcg (1 ml ampoule) of cyanocobalamin IM injection.
4. Must use the deltoid region for the injection.
5. Must not be in the menstrual cycle.
6. Must not be pregnant.
7. Must have no history of diabetes.
8. Must have a Body Mass Index (BMI) between 18.5 and 30.
9. Must have no scars, incisions, lipodystrophy, or infection at the injection site.
10. Must have no history of allergy to the medication.
12. not using centrally or peripherally acting analgesics or sedatives,
13. not having limb impairments,
14. having a VAS score of "0" before the injection,
15. agreeing to participate in the study.
Exclusion Criteria
2. Receiving oral or parenteral analgesic treatment before the study,
3. Receiving another injection in the deltoid region,
4. Developing a drug-related allergy or other complication,
5. Having a contact-related infectious disease,
6. Participants wishing to withdraw from the study.
18 Years
65 Years
ALL
No
Sponsors
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Necmettin Erbakan University
OTHER
Responsible Party
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Yadigar Ordu
Associate Professor
Principal Investigators
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Yadigar Yadigar
Role: PRINCIPAL_INVESTIGATOR
Necmettin Erbakan University
Central Contacts
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Other Identifiers
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ShotBlocker and Cold Needle
Identifier Type: -
Identifier Source: org_study_id