The Effect of Shotblocker on Pain Violence and Injection Satisfaction

NCT05647239 | Completed DMC

• 1 other identifier: 2017/400
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. .

Conditions

Pain

Keywords

Subcutaneous injection; Pain; ShotBlocker.

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Shotblocker 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

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Sevil Şahin

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: no masking done
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study was conducted in a randomized controlled study design in order to determine the effect of Shotblocker on pain and injection satisfaction in patients who were using DMAH and received subcutaneous injection after arthroplasty surgery in orthopedics training clinic.

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: December 12, 2022
• Study Start: April 2, 2017
• Primary Completion: May 1, 2018
• Study Completion: September 5, 2018
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)