Trials / Recruiting

RecruitingNCT06222216

The Effect of Chilled Needle on the Development of Pain and Ecchymosis in Subcutaneous Injection in Adults

The Effect of Chilled Needle on the Development of Pain and Ecchymosis in Subcutaneous Injection in Adults: A Prospective, Randomized Controlled Study

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 60 (estimated)

Sponsor: TC Erciyes University · Academic / Other
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Not accepted

Summary

Detailed description

Subcutaneous (SC) injection applications are the process of administering the drug to the loose connective tissue under the skin and is one of the most frequently applied parenteral drug administration methods among nursing practices. SC injections, which are frequently performed by nurses, often result in complications such as hematoma, ecchymosis and pain at the injection site. Although the field of healthcare is developing day by day, injection applications can still be painful and uncomfortable. These procedures increase the individual's stress levels before the procedure, causing them to experience fear and anxiety and reducing patient satisfaction. This may cause the application to fail or be repeated. Factors affecting pain and ecchymosis caused by subcutaneous injection include injection time, injection site, drug injected, dose injected, and needle size. Many nonpharmacological methods are applied to prevent or reduce these local side effects in subcutaneous injection applications. Cold application is accepted as an effective and easy-to-use method for SC injection. Cold application may also constrict peripheral blood vessels, reducing blood flow to the tissue and thus preventing ecchymosis. When the national and international literature is examined, there are studies using cold application to reduce pain and ecchymosis due to SC injection in adults. This study aimed to evaluate the effectiveness of cold injection, which is considered an alternative to cold therapy, in reducing pain and ecchymosis due to SC injection application. No study has been found in the literature evaluating the effectiveness of cold injection in preventing pain and ecchymosis due to SC injection application. Therefore, it is thought that this study will make a significant contribution to the literature and create a simple, comfortable and cost-free innovation. Preparation and use of cold injection is simple, easy and comfortable. It is anticipated that patients will be able to easily follow the procedure steps during the procedure. Therefore, this study aimed to examine the effect of the cooled needle on the development of pain and ecchymosis in SC injection application in adults. The research will be conducted as a randomized controlled, experimental clinical trial. The population of the research will consist of patients who applied to Erciyes University Health Application and Research Center General Surgery Service between the dates of the study. As a result of the analysis, it was decided to include a total of 60 people in the sample of the research. In collecting research data, the Case Report Form consisting of the Individual Introduction Form, Visual Comparison Scale and Ecchymosis Tracking Chart, created by the researchers by scanning the relevant literature, will be used. The data obtained in the research will be analyzed using the SPSS 24.0 program. Care will be taken to comply with ethical principles at every stage of the research. Before starting the application, an Academic Board Decision, ethics committee approval from the ERÜ Faculty of Medicine Ethics Committee and institutional permission from the ERÜ Health Application and Research Center will be obtained. Participants will first be explained the purpose of the research, given information about the research, and their written consent (Informed Volunteer Consent Form) will be obtained.

Conditions

Interventions

Type	Name	Description
OTHER	Chilled Needle	Before subcutaneous injection, 26G sterile disposable needles will be kept in the refrigerated compartment of the refrigerator for at least 24 hours. Immediately before SC injection, the needle will be removed from the refrigerator, placed in the ice box and placed next to the patient's bed. The needle temperature will be kept at 0-2 degrees Celsius in the ice box and controlled using an LCD digital thermometer. If Enoxaparin Sodium is in the ready injector, the drug in the injector will be drawn into the injector suitable for 1 cc SC injection application without loss of dose. The needle of the prepared syringe will be replaced with a cooled needle. Afterwards, the injection will be made in the designated area (outer side of the upper arm) in accordance with the SC injection procedure steps. After the injection, the patient's pain assessment will be made and marked on the ILC, and ecchymosis assessment will be made after 24, 48 and 72 hours.
OTHER	Control Group	SC injection will be administered to the control group in accordance with the clinical routine. No different action will be applied. The injection will be made in accordance with the SC injection protocol with a needle at room temperature, without applying any tools or procedures. After the injection, the patient's pain will be evaluated and marked on the VAS, and ecchymosis will be evaluated after 24, 48 and 72 hours.

Timeline

Start date: 2024-03-01
Primary completion: 2024-10-01
Completion: 2024-10-01
First posted: 2024-01-24
Last updated: 2024-05-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06222216. Inclusion in this directory is not an endorsement.