RecruitingNot ApplicableNCT06222216

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


Sponsor

TC Erciyes University

Enrollment

60 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria13

  • Able to speak and understand Turkish,
  • Those between the ages of 18-65,
  • Oriented to place and time,
  • Having no vision or hearing problems,
  • Not using psychiatric medication due to any psychiatric disease,
  • Not using central nervous system medication,
  • Not using narcotic analgesics,
  • Having a Visual Comparison Scale pain score of zero at the time of application,
  • Those who have not had SC injection in the last month,
  • Low molecular weight heparin therapy is ordered (Enoxaparin Sodium 1\*4000 IU),
  • Having an average pressure pain threshold of 8-16 pounds (Lb) with the Baseline Algometer device,
  • Has normal platelet, INR, and aPTT values,
  • Individuals who volunteer to participate in the study and sign the written voluntary consent form will be included in the research.

Exclusion Criteria4

  • Vital signs not within the reference range,
  • Those with signs of phlebitis, scar tissue, dermatitis, incision and infection in the area where the intervention will be performed,
  • Having had a mastectomy,
  • Patients who declare that they are addicted to alcohol and drugs will not be included in the research.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERChilled 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.

OTHERControl 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.


Locations(1)

Erciyes University Medical faculty hospital

Kayseri, Talas, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06222216


Related Trials