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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222216
• Other study ID #: Ali KAPLAN - Kayseri U
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Able to speak and understand Turkish,

2. Those between the ages of 18-65,

3. Oriented to place and time,

4. Having no vision or hearing problems,

5. Not using psychiatric medication due to any psychiatric disease,

6. Not using central nervous system medication,

7. Not using narcotic analgesics,

8. Having a Visual Comparison Scale pain score of zero at the time of application,

9. Those who have not had SC injection in the last month,

10. Low molecular weight heparin therapy is ordered (Enoxaparin Sodium 1*4000 IU),

11. Having an average pressure pain threshold of 8-16 pounds (Lb) with the Baseline Algometer device,

12. Has normal platelet, INR, and aPTT values,

13. Individuals who volunteer to participate in the study and sign the written voluntary consent form will be included in the research.

Exclusion Criteria:

1. Vital signs not within the reference range,

2. Those with signs of phlebitis, scar tissue, dermatitis, incision and infection in the area where the intervention will be performed,

3. Having had a mastectomy,

4. Patients who declare that they are addicted to alcohol and drugs will not be included in the research.

Related Conditions & MeSH terms

• Ecchymosis
• Pain
• Subcutaneous Injections

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Erciyes University Medical faculty hospital	Kayseri	Talas

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual Introduction Form	The form prepared by the researcher by examining the relevant literature; individuals' age, gender, marital status, etc. It consists of 7 questions that include socio-demographic characteristics such as. The individual identification form will be filled out by the researcher by meeting individuals face to face.	6 months
Primary	Visual Comparison Scale	The Visual Comparison Scale is a scale used to measure pain intensity. It is used to convert the pain value that cannot be measured numerically into numerical form. Two extreme definitions of the pain parameter are written at both ends of a 100 mm line, and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line, placing a dot, or pointing. It is a 100 mm (10 cm) ruler that can be used horizontally and vertically, with "painlessness" written on one end and "most severe pain possible" on the other end. "0 mm" means no pain, and "100 mm" means the most severe pain. The individual indicates the intensity of pain he feels on this ruler. Pain intensity score measurements will be evaluated in mm.	6 months
Primary	Octoberosis Tracking Chart	It is a form developed by researchers to track the development of ecchymosis in patients after subcutaneous injection, in which the date and time of SC injection and the ecchymosis at 24, 48, and 72 hours after injection are recorded.; In the project, an acetate pen will be used to measure ecchymosis in the injection area. In the literature, color changes smaller than 2 mm2 are not considered ecchymosis. Based on this information, in this study, color change smaller than 2 mm will be categorized as "no ecchymosis" and color change 2 mm and above will be categorized as "ecchymosis present".	6 months