Shotblocker® Use in Subcutaneous Injection

Chronic Spontaneous Urticaria Clinical Trial

Official title:

Use of Shotblocker® in Subcutaneous Injecting in Chronic Spontaneous Urticaria Patients: Randomized Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210323
• Other study ID #: SaglikBilimleriU
• Status: Completed
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: November 29, 2018

Study information

• Verified date: December 2019
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 29, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Urticaria

Intervention

Device:
• 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.
• Placebo group
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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 minutes
Secondary	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.	1 week
Secondary	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.	1 week