Clinical trial NCT04210323: Shotblocker® Use in Subcutaneous Injection
Official title: Use of Shotblocker® in Subcutaneous Injecting in Chronic Spontaneous Urticaria Patients: Randomized Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Spontaneous Urticaria
Keywords: omalizumab
subcutaneous
injection
ShotBlocker
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual comparison scales
timeFrame: 60 minutes
Secondary outcomes:
measure: The state-trait anxiety inventory form TX-I
timeFrame: 1 week
measure: Visual comparison scales
timeFrame: 1 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
state: Uskudar
Study officials:
References: