Chronic Spontaneous UrticariaNCT04210323
Shotblocker® Use in Subcutaneous Injection
A study testing ShotBlocker® in people with Chronic Spontaneous Urticaria, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study was to investigate the effect of subcutaneous injection with ShotBlocker® on patients with chronic spontaneous urticaria. Background: In chronic diseases such as CSU, after subcutaneous injection, problems such as pain, ecchymosis and hematoma may arise due to the injection technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- ShotBlocker®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2018to 29 Nov 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Communicative
- 18 years and older
- Body Mass Index (BMI) between 18.5-29.9 kg / m²
- CSU diagnosed
- Having regular subcutaneous omalizumab treatment
- Having not infection, scar tissue or incision on the posterior side of both upper arms and another parenteral treatment was not applied that side.
- Having not any haematological disease
- Volunteer to participate in the research
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul, Uskudar, 34668
About this study
Official title: Use of Shotblocker® in Subcutaneous Injecting in Chronic Spontaneous Urticaria Patients: Randomized Placebo Controlled Study
Aim: The aim of this study was to investigate the effect of subcutaneous injection with ShotBlocker® on patients with chronic spontaneous urticaria.
Background: In chronic diseases such as CSU, after subcutaneous injection, problems such as pain, ecchymosis and hematoma may arise due to the injection technique. This may lead to tissue loss at the injection site subsequent injections of subcutaneously administered omalizumab every twenty-eight days and increase the stress level.
Design: Randomized placebo controlled. Methods: Data were collected between June-November 2018 by including 90 patients out of 125 patients with Chronic Spontaneous Urticaria in Dermatology Clinic, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Patients were divided into three groups as intervention, control and shotblocker group. Patients in the placebo group were administered with the reverse side of ShotBlocker® during subcutaneous injection, and no intervention was performed in the control group. The group using ShotBlocker® for subcutaneous injection was compared with the placebo and control groups.
Read the detailed description
In chronic diseases such as CSU, after subcutaneous injection, problems such as pain, ecchymosis and hematoma may arise due to the injection technique. This may lead to tissue loss at the injection site subsequent injections of subcutaneously administered omalizumab every twenty-eight days and increase the stress level . It is stated in the literature that complications may be reduced significantly with appropriate technique in subcutaneous injection applications.
For this purpose, "ShotBlocker® (Bionix, Toledo, Ohio) was developed for subcutaneous and intramuscular injection applications. ShotBlocker® is a drug-free, non-invasive plastic device that can be applied for all age groups. It simulates the smaller nerves at the injection site and briefly blocks the pain gate in the central nervous system and slows down A-delta signals. ShotBlocker® is quick and easy to use, does not require any preliminary preparation, and has not been previously reported side effects. A surface of the device has a plurality of blunt spots these directly in contact with the skin. It is reported that the injection pain is reduced by applying light pressure to the contacting area with a short, non-sharp 2 mm thick blunt tip. There is a gap in the middle of the device to display the injection site and injection is applied through this gap.
In most international studies, it has been found that subcutaneous and intramuscular injection with ShotBlocker® has a substantial impact on reducing pain levels. It has been found the limited number of studies have been published in Turkey in order to evaluate the effectiveness of ShotBlocker® devices in pain. In the literature review, there was not found any published research about the use of Shot Blocker® in patients with CSU who received regular subcutaneous injections.
With the results of this research, it is believed that an effective method can be presented to reduce the pain and anxiety related with subcutaneous injection and increase the level of satisfaction in CSU patients, and to contribute the development of patient care with safe practices.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- ShotBlocker®, Placebo group
- Keywords
- omalizumab, subcutaneous, injection, ShotBlocker
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlocker®Device
The injection area gripped with ShotBlocker®, released after the drug administration and then the ShotBlocker® was removed. After injection, light pressure was applied to the injection area with dry cotton.
Placebo groupDevice
Also called The smooth surface of the ShotBlocker®
The smooth surface (opposite side) of the ShotBlocker® was placed in the injection area just before administration by an experience registered nurse and the drug was injected by holding it on the skin surface during the injection. The process was managed by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Shotblocker group | Experimental | ShotBlocker® was used by an experienced registered nurse under the researcher supervision. The injection area gripped with ShotBlocker®, released after the drug administration and then the ShotBlocker® was removed. After injection, light pressure was applied to the injection area with dry cotton. Receives: Device: ShotBlocker® |
| Placebo group | Placebo comparator | The smooth surface (opposite side) of the ShotBlocker® was placed in the injection area just before administration by an experience registered nurse and the drug was injected by holding it on the skin surface during the injection. The process was managed by the researcher. Receives: Device: Placebo group |
| Control group | No intervention | Subcutaneous injection was performed with normal subcutaneous drug administration steps by an experienced registered nurse and no additional method was applied. The application process of each patient was managed by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual comparison scales
Visual Analog Scales (VAS) were used in order to determine the pain and satisfaction of the administration. The scale comprise of a 10 cm long horizontal line with descriptive expressions at both ends (0 cm: no pain / no satisfaction and 10 cm on the right end: unbearable pain / very satisfied). Participants were asked to mark the pain level on this line.
Measured: 60 minutes
Secondary outcomes (2)
The state-trait anxiety inventory form TX-I
STAI was developed by Spielberger et al. In 1970 to measure state (TX-I) and trait anxiety levels (TX-II), and was adapted to Turkish society in 1985 by Öner and Le Compte. The State-Trait Anxiety Scale (TX-I) used in this study is a Likert-type scale consisting of 20 questions to determine how an individual feel at a given time and under certain circumstances. Each question has four options; 10 items are the reverse items (1,2,5,8,10,11,15,16,19 and 20), the lowest score is 20 and the highest score is 80. A higher score indicates a high level of anxiety and a lower score indicates a low level of anxiety.
Measured: 1 week
Visual comparison scales
Visual Analog Scales (VAS) were used in order to determine the pain and satisfaction of the administration. The scale comprise of a 10 cm long horizontal line with descriptive expressions at both ends (0 cm: no pain / no satisfaction and 10 cm on the right end: unbearable pain / very satisfied). Participants were asked to mark satisfaction level on this line.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start5 Jun 2018
- Primary completion5 Jun 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Kolcu, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210323
- Sponsor's protocol ID
- SaglikBilimleriU
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Shotblocker® in Subcutaneous Injecting in Chronic Spontaneous Urticaria Patients: Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04210323
- Acronym / sponsor ID
- SaglikBilimleriU
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- omalizumab, subcutaneous, injection, ShotBlocker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 24 Dec 2019 (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.
Aim: The aim of this study was to investigate the effect of subcutaneous injection with ShotBlocker® on patients with chronic spontaneous urticaria.
Background: In chronic diseases such as CSU, after subcutaneous injection, problems such as pain, ecchymosis and hematoma may arise due to the injection technique. This may lead to tissue loss at the injection site subsequent injections of subcutaneously administered omalizumab every twenty-eight days and increase the stress level.
Design: Randomized placebo controlled. Methods: Data were collected between June-November 2018 by including 90 patients out of 125 patients with Chronic Spontaneous Urticaria in Dermatology Clinic, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Patients were divided into three groups as intervention, control and shotblocker group. Patients in the placebo group were administered with the reverse side of ShotBlocker® during subcutaneous injection, and no intervention was performed in the control group. The group using ShotBlocker® for subcutaneous injection was compared with the placebo and control groups.
Detailed description
In chronic diseases such as CSU, after subcutaneous injection, problems such as pain, ecchymosis and hematoma may arise due to the injection technique. This may lead to tissue loss at the injection site subsequent injections of subcutaneously administered omalizumab every twenty-eight days and increase the stress level . It is stated in the literature that complications may be reduced significantly with appropriate technique in subcutaneous injection applications.
For this purpose, "ShotBlocker® (Bionix, Toledo, Ohio) was developed for subcutaneous and intramuscular injection applications. ShotBlocker® is a drug-free, non-invasive plastic device that can be applied for all age groups. It simulates the smaller nerves at the injection site and briefly blocks the pain gate in the central nervous system and slows down A-delta signals. ShotBlocker® is quick and easy to use, does not require any preliminary preparation, and has not been previously reported side effects. A surface of the device has a plurality of blunt spots these directly in contact with the skin. It is reported that the injection pain is reduced by applying light pressure to the contacting area with a short, non-sharp 2 mm thick blunt tip. There is a gap in the middle of the device to display the injection site and injection is applied through this gap.
In most international studies, it has been found that subcutaneous and intramuscular injection with ShotBlocker® has a substantial impact on reducing pain levels. It has been found the limited number of studies have been published in Turkey in order to evaluate the effectiveness of ShotBlocker® devices in pain. In the literature review, there was not found any published research about the use of Shot Blocker® in patients with CSU who received regular subcutaneous injections.
With the results of this research, it is believed that an effective method can be presented to reduce the pain and anxiety related with subcutaneous injection and increase the level of satisfaction in CSU patients, and to contribute the development of patient care with safe practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shotblocker group | Experimental | Device: ShotBlocker®ShotBlocker® was used by an experienced registered nurse under the researcher supervision. The injection area gripped with ShotBlocker®, released after the drug administration and then the ShotBlocker® was removed. After injection, light pressure was applied to the injection area with dry cotton. |
| Placebo group | Placebo comparator | Device: Placebo groupThe smooth surface (opposite side) of the ShotBlocker® was placed in the injection area just before administration by an experience registered nurse and the drug was injected by holding it on the skin surface during the injection. The process was managed by the researcher. |
| Control group | No intervention | –Subcutaneous injection was performed with normal subcutaneous drug administration steps by an experienced registered nurse and no additional method was applied. The application process of each patient was managed by the researcher. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Communicative
- 18 years and older
- Body Mass Index (BMI) between 18.5-29.9 kg / m²
- CSU diagnosed
- Having regular subcutaneous omalizumab treatment
Key exclusion criteria (1 listed)
- None
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®The injection area gripped with ShotBlocker®, released after the drug administration and then the ShotBlocker® was removed. After injection, light pressure was applied to the injection area with dry cotton. | Device | Shotblocker group |
| Placebo groupAlso: The smooth surface of the ShotBlocker®The smooth surface (opposite side) of the ShotBlocker® was placed in the injection area just before administration by an experience registered nurse and the drug was injected by holding it on the skin surface during the injection. The process was managed by the researcher. | Device | Placebo group |
Primary outcome
Visual comparison scales
Time frame: 60 minutes
Visual Analog Scales (VAS) were used in order to determine the pain and satisfaction of the administration. The scale comprise of a 10 cm long horizontal line with descriptive expressions at both ends (0 cm: no pain / no satisfaction and 10 cm on the right end: unbearable pain / very satisfied). Participants were asked to mark the pain level on this line.
2 secondary outcomes
The state-trait anxiety inventory form TX-I
Time frame: 1 week
Visual comparison scales
Time frame: 1 week
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 27 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
Not yet recruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
Chronic Spontaneous Urticaria
RecruitingPhase 3
Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks
Chronic Spontaneous Urticaria
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 ShotBlocker® in people with Chronic Spontaneous Urticaria, run by Saglik Bilimleri Universitesi 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 8 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 27 Dec 2019. 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 comparison scales (time frame: 60 minutes). 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 27 Dec 2019.