The Effect of Shotblocker on Pain Violence and Injection Satisfaction (Shotblocker)

The Effect of Shotblocker on Pain Violence and Injection Satisfaction in Subcutaneous Injectıon in Adults

This study was conducted to determine the effect of Shotblocker on pain level and injection satisfaction in SC injection administrations. The study was completed with 120 patients who were hospitalized in orthopedic clinic of a training and research hospital to receive treatment and met the inclusion criteria of the study. In addition to Standard practices for the clinic, the individuals in the intervention group received LMWH treatments via Shotblocker three times as once per day by administering SC from theside of the patients' upper armand thetreatment made with there ady injector of LMWH was ended within 20 seconds and the light pressure was applied to the injection site for 30 seconds. .

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Shotblocker

Detailed Description

I Intervention Group: Before starting the application, the researcher informed the patients in the intervention group about the purpose of the study and their verbal and written informed consents were obtained.

The individuals to be included in the intervention and control groups were randomized by a faculty member at the Biostatistics Department of a university in the computer environment. The application was initiated by including the patients meeting the inclusion criteria on 04.12.2017. During the study, no intervention was made on the routine treatments of the patients in the intervention and control groups. Before the application, patient information form of each patient was filled using face-to-face interview technique.

Since the patients included in the study were discharged early (mean hospitalization duration was 3 days), the first, third and fifth SC heparin injection (0.6 ml) administrations were performed by the researcher for three days. The application was made to the arm area due to the fact that Shotblocker was difficult to place in the abdominal area, and the outer side of the arm was preferred for subcutaneous injection administrations in the clinic where the study was conducted. Shotblocker was placed on the injection site determined on the outer side of the upper arm of the patient and the injection was administered by gently pressing the tool with the fingertips during the injection. Shotblocker was removed after removal of the injector. Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds. In the first minute after each SC injection application, the patients were asked about the pain level felt during the injection and the injection satisfaction status.

Control Group: Verbal and written informed consents of the patients included in the control group were obtained after they were informed by the researcher. Before the application, questions in patient information form were asked to each patient and how to use the VAS pain and injection satisfaction scale was explained. During injection, SC Clexan (0.6 ml) was injected on the site without using Shotblocker. Injections were completed in 20 seconds and the site was supported for 30 seconds. In the first minute after each SC injection administration, the patients were asked about pain level felt during the injection and injection satisfaction status.

In this study, the researcher administered all SC injections by throughout the study by considering the reliability of the study results.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Sevil Şahin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals whose treatment plan was Clexane 1x1 0.6 mg subcutaneous,
• Who were over 18 years of age,
• Who were conscious,
• Who had cognitive competence to answer the questionnaire,
• Who had no vision and hearing loss,
• Who had no bleeding clotting disorder,
• Who had platelet, INR and APTT values within normal limits,
• Who had no signs of scar tissue, incision or infection in the injection site,
• Who had no allergy history and agreed to participate in the study were included in the study.

Exclusion Criteria:

• The patients, who had amputation in the right/left arm region to be injected,
• Who had any scar tissue, incision, lipodystrophy or infection symptom on the injection site in the arm area,
• Who received hemodialysis treatment and had dialysis catheter,
• Who underwent mastectomy surgery and should not receive any practice/treatment on the arm on the operated side, were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Since the patients included in the study were discharged early (mean hospitalization duration was 3 days), the first, third and fifth SC heparin injection (0.6 ml) administrations were performed by the researcher for three days. The application was made to the arm area due to the fact that Shotblocker was difficult to place in the abdominal area, and the outer side of the arm was preferred for subcutaneous injection administrations in the clinic where the study was conducted. Shotblocker was placed on the injection site determined on the outer side of the upper arm of the patient and the injection was administered by gently pressing the tool with the fingertips during the injection. Shotblocker was removed after removal of the injector. Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds.	Device: Shotblocker; Shotblocker is a small plastic tool that can be used in all age groups in reducing pain due to injection, is non-medicinal, non-invasive, easy to use, and inexpensive and does not require material preparation
No Intervention: Control; Verbal and written informed consents of the patients included in the control group were obtained after they were informed by the researcher. Before the application, questions in patient information form were asked to each patient and how to use the VAS pain and injection satisfaction scale was explained. During injection, SC Clexan (0.6 ml) was injected on the site without using Shotblocker. Injections were completed in 20 seconds and the site was supported for 30 seconds. In the first minute after each SC injection administration, the patients were asked about pain level felt during the injection and injection satisfaction status. In this study, the researcher administered all SC injections by throughout the study by considering the reliability of the study results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level Measurement -Visual Analog Scale (VAS):	The scale developed by Priceet al., (1983) was used to evaluate the pain level perceived subjectively in many studies and found to be valid and reliable. The scale is composed of a 10-cm vertical or horizontal line starting with "no pain" and ending with "worst pain". The patient sare asked to indicate the severity of their pain by marking the appropriate point they see appropriate. The distance between the "no pain" starting point and this point is measured and recorded as "cm". The values range between 0 and 10 and the pain levels of patients are evaluated over 10 points as 0=no pain and 10=worst pain	Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds.

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): September 5, 2018

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Subcutaneous injection; ShotBlocker.
• Other Study ID Numbers: 2017/400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: there is no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No