The Effect of Shotblocker on Pain Violence and Injection Satisfaction

Pain Clinical Trial

— Shotblocker  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05647239
• Other study ID #: 2017/400
• Status: Completed
• Phase: N/A
• Start date: April 2, 2017
• Est. completion date: September 5, 2018

Study information

• Verified date: December 2022
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 5, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Sevil Sahin	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.