Shotblocker® Use in Subcutaneous Injection

NCT04210323 | Completed DMC

• 1 other identifier: SaglikBilimleriU
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spontaneous Urticaria

Keywords

omalizumab; subcutaneous; injection; ShotBlocker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The state-trait anxiety inventory form TX-I

  1 week

• Visual comparison scales

  1 week

Study Arms (3)

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.

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.

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.

Interventions

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.

Shotblocker group

Placebo group DEVICE

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.

Also known as: The smooth surface of the ShotBlocker®

Placebo group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Communicative
• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 24, 2019
• Study Start: June 5, 2018
• Primary Completion: June 5, 2018
• Study Completion: November 29, 2018
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)