The Effect of Shotblocker on Pain Violence and Injection Satisfaction

NCT ID: NCT05647239

Last Updated: 2022-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-02
• Study Completion Date: 2018-09-05

Brief 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. .

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.

Conditions

Pain

Keywords

Subcutaneous injection; Pain; ShotBlocker.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Shotblocker

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Sevil Şahin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sevil Şahin

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2017/400

Identifier Type: -

Identifier Source: org_study_id