HealthyNCT04634942
A Comparison of Two Different Methods to Reduce Intramusculer Injection Pain
A study testing Cryos REF 0971 Cold Spray and ShotBlocker BIONIX Press Firmly USA in people with Healthy, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cryos REF 0971 Cold Spray and ShotBlocker BIONIX Press Firmly USA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2010to 15 Aug 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Communication,
- Having no problems with vision and hearing,
- No pain, scar tissue, incision, lipodystrophy and signs of infection in the application area,
- Body mass index between 18.5 and 30,
- There is no history of allergy.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Turgut Ozal Medical Center
Malatya, 44000
About this study
Official title: A Comparison of Two dıfferent Methods to Reduce ıntramuscular ınjectıon paın; Cold Spray and ShotBlocker
When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.
The aim of the study is to use it to reduce pain associated with IM injection in adults.
To evaluate the effect of cold spray and ShotBlocker applications on pain.
Read the detailed description
When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.
The aim of the study is to use it to reduce pain associated with IM injection in adults.
To evaluate the effect of cold spray and ShotBlocker applications on pain. In this study, it was used to reduce pain associated with IM injection in adults.
It was aimed to evaluate the effect of ShotBlocker and cold spray application on pain. The research is planned to be completed between February 2020 and December 2020. The universe of the study, which was conducted as a randomized controlled trial model, consisted of all adult patients who received diclofenac sodium treatment in Malatya Turgut Özal Medical Center Emergency Service. 195 patients selected by the simple random sampling method (shotBlocker group = 39, shotBlocker placebo = 39 spray groups = 39, spray group placebo = 39, control group = 39) were included in the study. Participant Introduction Form and Visual Benchmarking Scale (VAS) were used to collect data. According to the characteristics of the data In independent groups, t test, ANOVA test, Mann Whitney U test, correlation were measured.
- Conditions
- Healthy
- Being tested
- Cryos REF 0971 Cold Spray, ShotBlocker BIONIX Press Firmly USA
- Keywords
- Intramuscular Injection, Pain, Cold Spray, ShotBlocker
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryos REF 0971 Cold SprayDevice
Cold Spray Coolant spray is manufactured from liquefied gases with high pressure. It acts by rapidly reducing the temperature in the body area where it is applied. The liquefied gas in the tube spreads on the skin in liquid form and takes the heat of the skin by turning into gas. The temperature of the area where it is applied drops from 30-32 degrees to 10-15 degrees. With the effect of the cold, the excitability of the nerve endings decreases, and thus the pain on the skin is felt by the person. Cold sprays, whose analgesic effect occurs immediately, are applied parallel to the muscle fibers in the area to be applied, from a distance of 15-45 centimeters, by squeezing for approximately 5-15 seconds. Cold sprays are suitable for long-term and multiple uses.
ShotBlocker BIONIX Press Firmly USADevice
ShotBlocker ShotBlocker is a plastic tool with a small and flat shape, with short and non-sharp protrusions on one side that connect with the skin. It resembles a horseshoe (C shaped) with its structure designed to expose the area to be injected. It is suitable for all age groups. It does not have any side effects. ShotBlocker can be used for both intramuscular and subcutaneous injections. The protruding surface of the ShotBlocker is held by pressing the skin during the injection and the process is performed from the part where the opening is.
| Study group | Role | What they receive |
|---|---|---|
| Cold Spray Group | Experimental | Cold spray group injection process step; In addition to the IM injection procedure steps, Cryos cold spray was applied to patients in this group after skin cleansing. Cryos cold spray sprayed 3 puffs from a distance of 20 cm to the skin, and the injection process was performed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle while entering the tissue on the VAS. Receives: Device: Cryos REF 0971 Cold Spray |
| ShotBlocker Group | Experimental | ShotBlocker group injection process step; In addition to the IM injection procedure steps, after cleansing the skin of the patients in this group, the protruding part of the ShotBlocker was placed in contact with the skin. ShotBlocker was pressed firmly against the skin and the injection was made through the central opening of the ShotBlocker. ShotBlocker was removed from the skin after the injection was completed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle while entering the tissue on the VAS. Receives: Device: ShotBlocker BIONIX Press Firmly USA |
| Control Group | No intervention | Control group injection process step; The individuals in this group were injected by following the routine IM injection procedure steps. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle entering the tissue on the VAS. |
| Cold Spray Placebo Group | Placebo comparator | Cold spray placebo group injection procedure step; In addition to the IM injection procedure steps, the patients in this group were treated with tap water in a cold spray bottle after cleansing the skin. After spraying 3 puffs of tap water in a placebo bottle at a distance of 20 cm to the skin, the injection was performed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle entering the tissue on the VAS. Receives: Device: Cryos REF 0971 Cold Spray |
| ShotBlocker Placebo Group | Placebo comparator | ShotBlocker placebo group injection procedure step; In addition to the IM injection procedure steps, in patients in this group, the non-protruding part of the ShotBlocker was placed in contact with the skin after skin cleaning. ShotBlocker was pressed firmly against the skin and the injection was applied through the central opening of the ShotBlocker. ShotBlocker was removed from the skin after the injection was completed. Receives: Device: ShotBlocker BIONIX Press Firmly USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of cold spray on intramuscular pain
The Visual Benchmark Scale (VAS) is a two-tailed 10 cm long scale used to measure pain, expressed by minimum no pain (0) and maximum very severe pain (10). Within 2 minutes of completing the injection, the individual was asked to mark his pain on the The Visual Benchmark Scale (VAS).
Measured: About 2 months
The effect of ShotBlocker on intramuscular pain
The Visual Benchmark Scale (VAS) is a two-tailed 10 cm long scale used to measure pain, expressed by minimum no pain (0) and maximum very severe pain (10). Within 2 minutes of completing the injection, the individual was asked to mark his pain on the The Visual Benchmark Scale (VAS).
Measured: About 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start25 Feb 2010
- Primary completion11 Jul 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, the randomization method was used to assign the patients to the groups to prevent manipulations that could be done consciously or unconsciously. A computer-assisted randomization program was used to make assignments to the groups. A random list was created in the computer environment by using random.org, assigning individuals to groups (117). 195 people, who will form the sample of the study, were divided into sets of 39, and sets were created by assigning numbers from 1 to 5 to each set. When the sets were obtained, the numbers from 1 to 5 were written on small papers, and group assignments were made by lot method. Group 1 = Control Group 2 = Cold Spray Placebo 3rd Group = Cold Spray 4th Group = ShotBlocker Group 5 = ShotBlocker Placebo
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634942
- Sponsor's protocol ID
- 2020/30
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research is a master thesis study. The research will be expected to be completed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two dıfferent Methods to Reduce ıntramuscular ınjectıon paın; Cold Spray and ShotBlocker
- ClinicalTrials.gov ID
- NCT04634942
- Acronym / sponsor ID
- 2020/30
- Conditions
- Healthy
- Keywords
- Intramuscular Injection, Pain, Cold Spray, ShotBlocker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 25 Feb 2010 (actual)
- Primary completion
- 11 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 18 Nov 2020 (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.
When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.
The aim of the study is to use it to reduce pain associated with IM injection in adults.
To evaluate the effect of cold spray and ShotBlocker applications on pain.
Detailed description
When the literature is reviewed, there are few studies evaluating cold spray or ShotBlocker in reducing pain associated with IM injection. Studies have shown that these applications are mostly used in children during vaccination or intravenous interventions. These methods are less commonly used on adults. Both methods without side effects are important in terms of being cheap, easy to use and reusable. As a result of the researches, these methods can provide a more comfortable injection experience and provide evidence for pain management, especially in adults sensitive to pain.
The aim of the study is to use it to reduce pain associated with IM injection in adults.
To evaluate the effect of cold spray and ShotBlocker applications on pain. In this study, it was used to reduce pain associated with IM injection in adults.
It was aimed to evaluate the effect of ShotBlocker and cold spray application on pain. The research is planned to be completed between February 2020 and December 2020. The universe of the study, which was conducted as a randomized controlled trial model, consisted of all adult patients who received diclofenac sodium treatment in Malatya Turgut Özal Medical Center Emergency Service. 195 patients selected by the simple random sampling method (shotBlocker group = 39, shotBlocker placebo = 39 spray groups = 39, spray group placebo = 39, control group = 39) were included in the study. Participant Introduction Form and Visual Benchmarking Scale (VAS) were used to collect data. According to the characteristics of the data In independent groups, t test, ANOVA test, Mann Whitney U test, correlation were measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- In the study, the randomization method was used to assign the patients to the groups to prevent manipulations that could be done consciously or unconsciously. A computer-assisted randomization program was used to make assignments to the groups. A random list was created in the computer environment by using random.org, assigning individuals to groups (117). 195 people, who will form the sample of the study, were divided into sets of 39, and sets were created by assigning numbers from 1 to 5 to each set. When the sets were obtained, the numbers from 1 to 5 were written on small papers, and group assignments were made by lot method. Group 1 = Control Group 2 = Cold Spray Placebo 3rd Group = Cold Spray 4th Group = ShotBlocker Group 5 = ShotBlocker Placebo
| Arm | Type | Receives |
|---|---|---|
| Cold Spray Group | Experimental | Device: Cryos REF 0971 Cold SprayCold spray group injection process step; In addition to the IM injection procedure steps, Cryos cold spray was applied to patients in this group after skin cleansing. Cryos cold spray sprayed 3 puffs from a distance of 20 cm to the skin, and the injection process was performed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle while entering the tissue on the VAS. |
| ShotBlocker Group | Experimental | Device: ShotBlocker BIONIX Press Firmly USAShotBlocker group injection process step; In addition to the IM injection procedure steps, after cleansing the skin of the patients in this group, the protruding part of the ShotBlocker was placed in contact with the skin. ShotBlocker was pressed firmly against the skin and the injection was made through the central opening of the ShotBlocker. ShotBlocker was removed from the skin after the injection was completed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle while entering the tissue on the VAS. |
| Control Group | No intervention | –Control group injection process step; The individuals in this group were injected by following the routine IM injection procedure steps. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle entering the tissue on the VAS. |
| Cold Spray Placebo Group | Placebo comparator | Device: Cryos REF 0971 Cold SprayCold spray placebo group injection procedure step; In addition to the IM injection procedure steps, the patients in this group were treated with tap water in a cold spray bottle after cleansing the skin. After spraying 3 puffs of tap water in a placebo bottle at a distance of 20 cm to the skin, the injection was performed. Within 2 minutes after the injection process was completed, the patient was allowed to mark the intensity of pain caused by the needle entering the tissue on the VAS. |
| ShotBlocker Placebo Group | Placebo comparator | Device: ShotBlocker BIONIX Press Firmly USAShotBlocker placebo group injection procedure step; In addition to the IM injection procedure steps, in patients in this group, the non-protruding part of the ShotBlocker was placed in contact with the skin after skin cleaning. ShotBlocker was pressed firmly against the skin and the injection was applied through the central opening of the ShotBlocker. ShotBlocker was removed from the skin after the injection was completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being 18 years or older
- Communication,
- Having no problems with vision and hearing,
- No pain, scar tissue, incision, lipodystrophy and signs of infection in the application area,
- Body mass index between 18.5 and 30,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Cryos REF 0971 Cold SprayCold Spray Coolant spray is manufactured from liquefied gases with high pressure. It acts by rapidly reducing the temperature in the body area where it is applied. The liquefied gas in the tube spreads on the skin in liquid form and takes the heat of the skin by turning into gas. The temperature of the area where it is applied drops from 30-32 degrees to 10-15 degrees. With the effect of the cold, the excitability of the nerve endings decreases, and thus the pain on the skin is felt by the person. Cold sprays, whose analgesic effect occurs immediately, are applied parallel to the muscle fibers in the area to be applied, from a distance of 15-45 centimeters, by squeezing for approximately 5-15 seconds. Cold sprays are suitable for long-term and multiple uses. | Device | Cold Spray Group, Cold Spray Placebo Group |
| ShotBlocker BIONIX Press Firmly USAShotBlocker ShotBlocker is a plastic tool with a small and flat shape, with short and non-sharp protrusions on one side that connect with the skin. It resembles a horseshoe (C shaped) with its structure designed to expose the area to be injected. It is suitable for all age groups. It does not have any side effects. ShotBlocker can be used for both intramuscular and subcutaneous injections. The protruding surface of the ShotBlocker is held by pressing the skin during the injection and the process is performed from the part where the opening is. | Device | ShotBlocker Group, ShotBlocker Placebo Group |
Primary outcome
The effect of cold spray on intramuscular pain
Time frame: About 2 months
The Visual Benchmark Scale (VAS) is a two-tailed 10 cm long scale used to measure pain, expressed by minimum no pain (0) and maximum very severe pain (10). Within 2 minutes of completing the injection, the individual was asked to mark his pain on the The Visual Benchmark Scale (VAS).
The effect of ShotBlocker on intramuscular pain
Time frame: About 2 months
The Visual Benchmark Scale (VAS) is a two-tailed 10 cm long scale used to measure pain, expressed by minimum no pain (0) and maximum very severe pain (10). Within 2 minutes of completing the injection, the individual was asked to mark his pain on the The Visual Benchmark Scale (VAS).
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 Nov 2020.
- Individual participant dataSharing planned: No. This research is a master thesis study. The research will be expected to be completed.
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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 Cryos REF 0971 Cold Spray and ShotBlocker BIONIX Press Firmly USA in people with Healthy, run by Inonu 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 6 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 18 Nov 2020. 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?
The effect of cold spray on intramuscular pain (time frame: About 2 months). 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 18 Nov 2020.